Digital Health

23andMe Unveils Total Health to Become a HealthTech Company

23andMe, renowned for ancestry tracing, steps into healthcare with “Total Health”, a service set to decode your health secrets embedded in your genes for $1,188 a year.

23andme offering. Source: 23andme

This leap from mere curiosity to actionable health insights exemplifies 23andMe’s ethos of evolving with scientific advancements. It also addresses earlier concerns on the misinterpretation of the data, false positives, and consumers left without healthcare professional support that the company faced in the past.

23andme TotalHealth screenshots. Source: 23andme
23andMe journey into healthcare:
  • 2006: Founded with the aim to help people access, understand, and benefit from the human genome.
  • 2007: Launched Personal Genome Service.
  • 2013: FDA issues a warning letter prohibiting marketing of the Saliva Collection Kit and PGS until it received proper marketing authorization for the device
  • 2015: FDA authorized the marketing of a Bloom Syndrome carrier test, marking a significant regulatory milestone.
  • 2017: Expanded to offer risk reports for conditions like Parkinson’s and Alzheimer’s.
  • 2021: Acquired Lemonaid Health, stepping into telehealth.
  • 2023: Launches Total Health, transitioning into a holistic healthcare provider.

Total Health, employing exome sequencing, unravels the entire protein-coding region of your DNA, spotlighting “actionable” genes. With healthcare practitioners on board, 23andMe’s endeavor isn’t just to hand over a report, but to guide you through a personalized health regimen, marking a significant stride in proactive healthcare.

This service, available from November seems to be a significant milestone in pivoting 23andme from scientific entertainment and curiosity, towards a proper healthcare service.


Early Cancer Detection: The Promise of Protein Biomarker Analysis

Cancer detection has seen a revolutionary transformation, thanks to the emergence of a technique known as Protein Biomarker Analysis using Proximity Ligation Assays (PLA). This novel approach is a game changer in identifying cancer at its nascent stages, improving the chances of successful treatment and recovery. But what exactly is PLA, and how does it contribute to early cancer detection? Let’s delve into this promising frontier of medical technology.

Understanding Protein Biomarker Analysis

At its core, Protein Biomarker Analysis is about studying specific proteins – called biomarkers – that are often associated with the presence of cancer. Unlike the conventional methods which rely on identifying genetic mutations, this analysis focuses on proteins, offering a real-time glimpse into the presence of cancer.

A proximity ligation assay identifies complexes (red) containing the Notch1 receptor and the heparan sulfate proteoglycan Syndecan-3 in skeletal muscle satellite cells stained for Syndecan-4 (green). Pisconti et al. show that Syndecan-3 is required for Notch1’s cleavage by the metalloproteinase ADAM17 and downstream signaling controlling satellite cell proliferation and differentiation.
This image is available to the public to copy, distribute, or display under a Creative Commons Attribution-Noncommercial-Share Alike 3.0 Unported license.
Reference: Pisconti et al. (2010) J. Cell Biol.190, 427-441.
Published on: August 9, 2010.
doi: 10.1083/jcb.201003081

Some of the innovative approaches and technologies in Protein Biomarker Analysis are:

  1. Multiplexed Proximity Ligation Assays: A high throughput protein biomarker discovery tool has been developed that utilizes multiplexed proximity ligation assays in a homogeneous format. This innovative platform comprises four 24-plex panels profiling 74 putative biomarkers with sub-picomolar sensitivity, each consuming only 1 μl of human plasma sample​​.
  2. TaqMan® Protein Assays: TaqMan® Protein Assays represent an adapted form of PLA technology, invented by Ulf Landegren, Simon Fredriksson, and colleagues. This technology melds antibody-protein binding with real-time PCR-based detection of the reporter nucleic acid sequence. It’s an illustrative example of how PLA technology can be adapted and expanded for varied applications in protein analysis​.
  3. Multiplexed Protein Detection Procedure: A proximity ligation-based multiplexed protein detection procedure has been presented wherein several selected proteins can be detected via unique nucleic-acid identifiers. This method holds promise for a more comprehensive understanding and detection of protein complexes associated with cancer​​.
  4. Nanoparticle-Based Proximity Ligation Assay: This method enhances the traditional PLA by replacing antibody–DNA conjugates with nanoparticles. These nanoparticles create ultradetectable PCR templates by capturing biotinylated oligonucleotides and catalyzing ligation, thus potentially offering a more sensitive and quantitative assay for protein analysis​​.
Applied Biosystems™ TaqMan™ Protein Assays Core Reagents Base Kit; Source:
Applied Biosystems™ TaqMan™ Protein Assays Core Reagents Base Kit

The Role of Proximity Ligation Assays (PLA)

Proximity Ligation Assays are the tools that enable this intricate analysis. They help in measuring and visualizing protein complexes, which in turn, provide critical insights into the presence and progression of cancer. The beauty of PLA lies in its ability to offer real-time information, which is crucial for early detection and subsequent treatment of cancer.

Advantages Over Traditional Methods

  1. Early Detection: As mentioned earlier, one of the standout benefits of PLA is its potential for early cancer detection. By identifying protein biomarkers, it’s possible to spot cancer long before symptoms surface.
  2. Real-Time Analysis: Unlike genetic mutation tests that might not provide a current status of cancer, PLA offers real-time information, which is invaluable in determining the most effective treatment plan.
  3. Enhanced Accuracy: By honing in on specific protein complexes, PLA tends to have a higher degree of accuracy compared to traditional testing methods.

The Future of Cancer Detection

Integrating Proximity Ligation Assays in routine cancer screening could herald a new era in oncology. By enabling early and accurate detection, PLA empowers healthcare professionals and offers hope to individuals and families affected by cancer.

Concluding Thoughts

The journey towards a cancer-free world is laden with numerous challenges, yet with innovative technologies like Protein Biomarker Analysis via Proximity Ligation Assays, we are inching closer to that goal. As research advances, there’s an optimistic outlook that PLA will become a cornerstone in cancer diagnostics, offering a beacon of hope for millions affected by this dreaded disease.

This exploration into the world of Protein Biomarker Analysis is a testimony to the relentless human endeavor to combat cancer. It’s a significant stride towards not only understanding this complex disease better but also combating it with more precision and effectiveness.

Note: this content has been created using experimental Generative AI features.
While edited, authored, and reviewed by humans it may include some biased or incorrect statements.

Digital Health MedTech

Pear Therapeutics: The Rise and Fall of a Digital Therapeutics Pioneer

Pear Therapeutics, once a leader in prescription digital therapeutics (PDT or DTx), has recently filed for bankruptcy. In this blog post, we’ll explore the history of the company, its milestones, and the reasons behind its unforeseen downfall, while also shedding light on its competitors in the digital therapeutics market.

Pear Therapeutics: History

Established in 2013 by Dr. Corey McCann, Pear Therapeutics aspired to revolutionize the treatment of various disorders by merging the power of software and medicine. Based in Boston, Massachusetts, the company aimed to develop, manufacture, and distribute FDA-approved software applications that would work in tandem with conventional medications to enhance their effectiveness.

Pear Therapeutics’ Key Achievements

FDA Approvals

Throughout its existence, Pear Therapeutics managed to obtain three FDA approvals for its products, establishing itself as a significant player in the digital therapeutics industry:

  1. reSET (2017) – The first FDA-approved PDT, reSET is designed for treating substance use disorder. This groundbreaking achievement demonstrated that software could be clinically effective in treating patients.
  2. reSET-O (2018) – A follow-up to reSET, this PDT is aimed at helping patients with opioid use disorder as an adjunct to outpatient treatment. It includes buprenorphine and contingency management, a behavioral therapy approach.
  3. Somryst (2020) – The first FDA-approved PDT for chronic insomnia, Somryst offers cognitive behavioral therapy for insomnia (CBT-I) through a digital platform, making it more accessible for patients who might not have access to in-person therapy.

Partnerships and Collaborations

Throughout its journey, Pear Therapeutics partnered with several industry giants to develop and distribute its PDTs. These collaborations included deals with Novartis, Sandoz, and Blue Cross Blue Shield, among others.

The Path to Bankruptcy: Crucial Factors

Market Penetration and Adoption Challenges

Despite the groundbreaking nature of its PDTs, Pear Therapeutics faced significant challenges in gaining market traction. The healthcare industry is often slow to adopt new technologies, and the novel concept of PDTs faced resistance from both physicians and insurers.

Reimbursement Issues

One of the most significant hurdles for Pear Therapeutics was obtaining adequate reimbursement from insurance companies. Many insurers were hesitant to cover the costs of the treatments, which made it difficult for patients to access them.

High Development and Marketing Costs

Developing PDTs is a time-consuming and costly process. Pear Therapeutics had to invest heavily in research, development, and clinical trials to bring its products to market. Additionally, the company faced considerable marketing expenses to promote its PDTs in a market dominated by traditional pharmaceuticals.

Management Missteps

Some critics argue that Pear Therapeutics’ management made a series of missteps that ultimately contributed to the company’s downfall. This includes an overemphasis on partnerships at the expense of product innovation, and a lack of clear, focused strategies to address the challenges faced in the market.

COVID-19 Pandemic Impact

The COVID-19 pandemic brought about significant challenges for Pear Therapeutics, particularly in the area of patient access. As healthcare providers struggled to adapt to the new normal, digital therapeutics adoption was deprioritized, and this further impeded the company’s growth.

Competitors in the Digital Therapeutics Space

While Pear Therapeutics was a pioneer in the prescription digital therapeutics (PDT) field, it wasn’t the only company trying to make its mark. Some of the key competitors in the digital therapeutics market include:

Akili Interactive

Akili Interactive is a Boston-based company that has developed EndeavorRx, the first FDA-approved video game for treating attention deficit hyperactivity disorder (ADHD) in children. EndeavorRx is a digital intervention that aims to improve attention function in pediatric patients with ADHD.


Voluntis, a French digital therapeutics company, specializes in creating software to assist patients in managing chronic conditions. Their flagship product, Insulia, is an FDA-cleared digital therapeutic designed to help patients with type 2 diabetes manage their insulin dosages.

Big Health

Big Health, a UK-based company, focuses on developing digital therapeutics for mental health. Their two major products are Sleepio, a digital CBT-I program for insomnia, and Daylight, a digital CBT-based program for anxiety. While not FDA-approved like Pear’s Somryst, Sleepio has demonstrated clinical effectiveness in multiple studies.

Omada Health

Omada Health is a San Francisco-based digital health company that offers a suite of digital programs aimed at chronic disease prevention and management. Their flagship program, the Omada Diabetes Prevention Program, is a CDC-recognized digital intervention to help patients with prediabetes make lifestyle changes to prevent or delay the onset of type 2 diabetes.

Click Therapeutics

Click Therapeutics, a New York-based digital therapeutics company, is focused on developing software as a prescription medical treatment. One of their most prominent products, Clickotine, is a digital smoking cessation program designed to help users quit smoking. The company is also working on a digital treatment for major depressive disorder called CT-152, currently in clinical trials.


Pear Therapeutics was a trailblazer in the field of prescription digital therapeutics, achieving FDA approvals and forging partnerships with industry giants. However, the company’s inability to overcome market penetration, adoption, and reimbursement challenges, coupled with high development costs, management missteps, and the impact of the COVID-19 pandemic, ultimately led to its bankruptcy. With multiple players such as Akili Interactive, Voluntis, Big Health, Omada Health, and Click Therapeutics still in the game, it remains to be seen how the digital therapeutics landscape will evolve and what future innovations may emerge.

Digital Health MedTech

Bigfoot Medical: Pioneering Diabetes Management Solutions & Their Future Prospects

Beginning of March 2023 Bigfoot Medical announced it has FDA clearance for the Android version of the Bigfoot Unity® Mobile App, a necessary component of the Bigfoot Unity® Diabetes Management System. Given that 41 percent of U.S. smartphone users choose Android devices, this clearance enables expanded access to a large group of people with Type 2 diabetes. Bigfoot Unity has been compatible with iOS devices since May 2021. 

The medical device landscape is continuously evolving, with companies like Bigfoot Medical revolutionizing diabetes care through cutting-edge technology and artificial intelligence. In this post, we explore the history, achievements, and future prospects of Bigfoot Medical, an industry leader in diabetes management solutions.

Early Days: Laying the Groundwork for Success

Founded in 2014 by Jeffrey Brewer and Bryan Mazlish, Bigfoot Medical was driven by a personal connection to the challenges of diabetes management. Their goal is to create an integrated system that simplifies and enhances diabetes care using advanced technology and AI.

From day one, Bigfoot Medical focused on patient-centric solutions, which has been instrumental in their success and significant progress in the diabetes care sector.

Achievements: Transforming Diabetes Care with Bigfoot Unity™

Bigfoot Medical’s flagship product, the Bigfoot Unity™ Diabetes Management System, is an innovative solution that combines a continuous glucose monitor (CGM), insulin pen caps, and a mobile app to provide a seamless, data-driven experience for those living with insulin-requiring diabetes.

Key achievements of Bigfoot Medical include:

  1. FDA Approval: In 2021, Bigfoot Medical received FDA clearance for the Bigfoot Unity™ System, a major milestone in their journey.
  2. Enhanced Patient Outcomes: The Bigfoot Unity™ System has demonstrated improved glycemic control, reduced hypoglycemic events, and enhanced quality of life for users.
  3. Strategic Partnerships: Bigfoot Medical has formed alliances with industry leaders like Abbott, ensuring technology integration and broader patient reach.
  4. Awards and Recognitions: The company has garnered numerous accolades, such as being named one of Fast Company’s Most Innovative Companies in 2021.

Competition and Market Size: Navigating a Dynamic Industry

The global diabetes care devices market is substantial, with a value of $20.0 billion in 2020, and is projected to reach $38.3 billion by 2030, growing at a CAGR of 6.6% from 2021 to 2030. This significant market size is attributed to the increasing prevalence of diabetes, the need for better management solutions, and rising awareness about diabetes care. In such a dynamic industry, Bigfoot Medical faces competition from various established and emerging players, such as Medtronic, Dexcom, Insulet, and Tandem Diabetes Care, which offer insulin pumps, CGMs, and other diabetes management solutions.

Despite the competitive landscape, Bigfoot Medical differentiates itself through its unique, integrated approach to diabetes care, focusing on providing a seamless, data-driven experience for users. Additionally, the company’s commitment to leveraging AI and machine learning for personalized treatment plans offers a competitive edge that could attract patients seeking tailored solutions for their diabetes management. By continuing to innovate and staying ahead of the curve, Bigfoot Medical aims to secure a significant share of this growing market, providing millions of diabetes patients worldwide with advanced, user-friendly, and effective diabetes care solutions.

Future Prospects: Embracing Continued Innovation

With a strong foundation and proven success, Bigfoot Medical is poised to keep transforming diabetes care. Their future prospects encompass:

  1. Diversified Product Line: Bigfoot Medical plans to expand its product offerings, addressing a broader range of patient needs.
  2. Global Market Reach: The company aims to make its groundbreaking solutions accessible to patients worldwide.
  3. Personalized Medicine: Bigfoot Medical is committed to harnessing AI and machine learning to develop tailored treatment plans for diabetes patients, further enhancing outcomes and quality of life.
  4. Research and Collaborations: The company will continue to work with research institutions, healthcare providers, and industry partners to drive innovation and uncover new ways to improve diabetes care.

Bigfoot Medical’s dedication to enhancing the lives of diabetes patients is evident in their history of innovation and promising future. As they continue to evolve and expand, Bigfoot Medical will undoubtedly remain a leader in the medical device industry, shaping the future of diabetes management for millions around the globe. With a unique approach to diabetes care and a commitment to delivering personalized solutions, Bigfoot Medical is well-positioned to make a lasting impact on patients’ lives and redefine the standards of diabetes care in the years to come.

Digital Health MedTech

The Top 10 Medical Devices Types Revolutionizing Digital Health in 2023

Digital health in 2023 continues to advance rapidly. Medical devices that utilize digital technology are becoming increasingly popular and offer a wide range of benefits, including improved accuracy, increased convenience, and greater efficiency. In this post, we’ll take a look at the top 10 medical devices revolutionizing digital health in 2023.

Smart Inhalers

Smart inhalers are innovative medical devices that can help patients manage their asthma and other respiratory conditions more effectively. These devices are equipped with sensors that can track the usage of the inhaler, monitor patient symptoms, and provide feedback to help optimize treatment plans.

Wearable Glucose Monitors

Wearable glucose monitors are becoming increasingly popular for individuals with diabetes. These devices provide continuous monitoring of blood glucose levels and can alert the wearer when their levels are too high or too low, allowing for more timely and effective management of the condition.

Remote Patient Monitoring Systems

Remote patient monitoring systems enable healthcare providers to monitor patients remotely, reducing the need for in-person visits and improving patient outcomes. These systems typically involve wearable devices that can track vital signs, medication adherence, and other health metrics.

Virtual Reality Therapy Devices

Virtual reality therapy devices are a new and innovative way to treat a range of mental health conditions, including anxiety and PTSD. These devices allow patients to immerse themselves in a virtual environment, providing a safe and controlled space to address and overcome their fears.

Portable Ultrasound Machines

Portable ultrasound machines are an exciting development in medical imaging technology, allowing for easier and more accessible imaging in a range of clinical settings. These devices are also more cost-effective than traditional ultrasound machines, making them valuable tools for healthcare providers.

  • Philips CX50
  • Chison Sonobook 9
  • Mindray M7
  • GE Logiq e

AI-Powered Diagnostics Tools

AI-powered diagnostics tools are changing the game when it comes to early disease detection and diagnosis. These devices can analyze large amounts of data to detect patterns and anomalies that may indicate a health condition, enabling earlier intervention and improved patient outcomes.

Smart Pill Bottles

Smart pill bottles are an excellent tool for medication adherence, particularly for patients with chronic conditions who need to take multiple medications. These devices can track medication usage, remind patients to take their medication and alert healthcare providers if medication is missed

Robotic Exoskeletons

Robotic exoskeletons are a new and exciting development in the field of physical therapy. These devices can assist patients with mobility issues, providing support and assistance with movement and helping to reduce the risk of falls and other injuries.

Wireless ECG Monitors

Wireless ECG monitors are a convenient and effective way to monitor cardiac health. These devices can be worn for extended periods, providing continuous monitoring of heart rate and rhythm, and alerting healthcare providers to potential issues in real time.

Smart Contact Lenses

Smart contact lenses are an exciting new development in digital health, allowing for continuous monitoring of a range of health metrics, including glucose levels, intraocular pressure, and other vital signs. These devices could have a significant impact on patient outcomes, particularly for those with chronic conditions. We have seen early pioneers (Alcon+Verily, Mojo) failing to deliver on their promises, but the platform has its potential and the research continues. The most recent advance was when the Ulsan National Institute of Science and Technology (UNIST) scientists led by Dr. Seol Seung-Kwon and Professor Lim-Doo Jeong made a significant step forward in 3D-printed smart lenses.

Medical devices are revolutionizing digital health in 2023, offering patients and healthcare providers new tools to improve patient outcomes, reduce costs, and increase access to care. From wearable glucose monitors to smart inhalers and AI-powered diagnostics tools, the future of digital health looks bright. Are you working on any of the trends above? Do you have a new disrupting healthcare technology in mind? Let us know!

MedTech Pharma Marketing

Digital marketing in MedTech and Pharma

Is digital marketing in MedTech and Pharma similar? Understanding the specifics of MedTech and Digital Health digital marketing is essential to success.

MedTech digital marketing

The four main components of digital marketing in the medical devices industry are digital strategy consulting, digital content creation and management, digital campaign execution, and analytics.

  • Digital Marketing Consulting involves helping MedTech companies assess their priorities and strengths, optimize their operations and innovation, and develop effective go-to-market strategies.
  • Digital content creation and management involves producing engaging and informative content for various channels such as email, social media, blogs, webinars, etc. that showcase medical devices’ value proposition and benefits.
  • Digital campaign execution involves designing and implementing marketing campaigns that target specific segments of healthcare professionals (HCPs) or patients using digital tools such as CRM systems, marketing automation platforms, SEO/SEM techniques, etc.
  • Digital analytics involves measuring and evaluating the performance and impact of digital marketing activities using data-driven methods such as web analytics, customer feedback surveys, ROI calculations, etc.

Digital consulting is a vital component of digital marketing for medical devices and should be a first step. It helps MedTech companies to:

  • Define their vision and goals for digital transformation
  • Assess their current capabilities and gaps
  • Develop a roadmap and action plan for implementing digital solutions
  • Align their organization and culture with digital best practices

Digital marketing of medical devices in comparison to pharmaceuticals

Digital marketing for Medical Devices in many aspects is similar to the pharmaceutical industry, however, there are significant differences.

What are the similarities between MedTech and Pharma digital marketing?

  • Both Pharma and MedTech use digital tools to inform and influence HCPs and patients about their products and services.
  • Both industries rely on data and analytics to measure and optimize their digital marketing activities.
  • Medical Devices face regulatory challenges and compliance issues when engaging with their audiences online that are similar to those in pharmaceuticals.

The key differences between Pharma and Medical Devices digital marketing are that:

  • Medtech companies tend to have more complex products that require more technical expertise and demonstration than pharma companies.
  • Medtech companies have a wider range of stakeholders to consider, such as hospital administrators, payers, distributors, etc. than pharma companies.
  • Medtech companies have more opportunities to leverage digital health and digital therapeutics (DTx), such as connected devices, apps, sensors, etc. that can enhance their value proposition and customer experience than pharma companies

Outsourcing digital marketing services in the MedTech industry

Medical device companies may look for different services or support when deciding to outsource digital marketing, depending on their needs and goals.

Some possible services or support are:

  • Quality assurance: ensuring that the digital marketing activities comply with regulatory standards and best practices.
  • Content production and management: producing digital content or products such as websites, apps, videos, etc. that showcase the features and benefits of medical devices.
  • E-commerce: setting up and managing online platforms that allow customers to order and purchase medical devices easily and securely.
  • Virtual sales channels: creating and maintaining digital tools that enable sales reps to communicate and demonstrate medical devices to HCPs remotely.
  • Data analytics: collecting and analyzing data from digital marketing activities to measure performance, optimize campaigns, and generate insights

Generally, smaller MedTech companies may need more comprehensive and flexible services and support than larger companies, as they may have less experience and capacity for digital marketing. Larger companies may need more specialized and customized support than smaller companies, as they may have more complex and diverse needs for digital marketing.

Some possible factors that influence digital marketing service requirements are:

  • The type and complexity of medical devices that the company produces or sells.
  • The level of expertise and resources that the company has internally for digital marketing.
  • The scope and scale of digital marketing activities that the company wants to undertake.
  • The budget and timeline that the company has for digital marketing outsourcing.

The skillset of MedTech digital marketer

Some of the skills of a digital marketing expert from pharma are transferrable to provide medical device digital marketing services too. For example, both sectors require:

  • Knowledge of regulatory requirements and compliance standards.
  • Ability to create engaging and informative content for different audiences and channels.
  • Proficiency in using various digital tools and platforms to design, execute, and measure campaigns.

However, there are also some differences between pharma and medical device digital marketing that may require additional skills or adaptation. The key differences are that:

  • Medical device customers have different expectations and needs than pharma customers. They may be more interested in product features, benefits, demonstrations, or testimonials than in disease mechanisms or outcomes.
  • Medical devices are more diverse and complex than drugs. They can range from tissue grafts to prostheses to digital devices and apps. They may also have different modes of action, indications, or usage scenarios.
  • Medical devices may have shorter product life cycles than drugs. They may face more competition or innovation from other players in the market. They may also require more frequent updates or upgrades.

Therefore, a digital marketing expert to excel in the Medical Devices industry may need to understand the nuances of device marketing and how to tailor their strategies accordingly. MedTech digital marketing specialist has to learn about the specific types of devices they are marketing and how they work, who they serve, and what value they offer. Finally, digital marketer in MedTech industry has to be flexible and agile in responding to changing market conditions and customer feedback.

Regulatory requirements for medical device digital marketing

Regulatory requirements for medical device digital marketing vary depending on the type of device, the market, and the channel. Some of the general requirements are:

  • Medical device digital marketing must be truthful, accurate, and not misleading.
  • Medical device digital marketing must comply with the relevant laws and regulations of each country or region where they operate.
  • Medical device digital marketing must respect the data privacy and security of customers and users.

Some examples of specific regulatory requirements for medical device digital marketing are:

  • The Medical Devices Regulation (MDR) applies since 26 May 2021 in the European Union. It sets out new rules for placing medical devices on the market, including requirements for clinical evidence, post-market surveillance, labeling, and advertising.
  • The In Vitro Diagnostic Devices Regulation (IVDR) applies since 26 May 2022 in the European Union. It replaces Directive 98/79/EC and introduces new classification rules, conformity assessment procedures, performance evaluation requirements, etc. for in vitro diagnostic devices.
  • The Food and Drug Administration (FDA) provides guidance documents with digital health content for medical device manufacturers in the United States. They cover topics such as software as a medical device, mobile medical applications, clinical decision support software, cybersecurity, artificial intelligence/machine learning, etc.
Digital Health

Germany leading in DTx reimbursement with 42 DiGA-approved apps

With four more Digital Therapeutics (DTx) added in January, Germany is a leader in reimbursing of prescribed digital health applications. The DiGA directory lists now 42 digital therapeutics available to be prescribed and reimbursed for German patients.

It has been almost two years since we have been discussing the approval of Deprexis, the 11th DiGA-approved digital therapeutics. The pace of the German regulator, the Federal Institute for Drugs and Medical Devices (BfArM) increased dramatically.

BfArM has so far received 165 applications. By the 22nd of February 2023, there were 43 positive decisions. Sixteen DTx are DiGA-approved permanently, 27 are approved provisionally (gathering additional RWE), and five were removed from the directory (two of them on developer request).

BfArM - DiGA assessment of digital therapeutics results
BfArM – DiGA assessment of digital therapeutics results

How to get a digital health application (DiGA) in Germany?

  1. Arrange a doctor’s appointment

    It is best to let your doctor advise you on your desired DiGA DTx.

  2. Get a prescription

    You get a red prescription. If you do not receive one, the health insurance company can also pay for the DiGA without a prescription.

  3. Submit

    Submit the prescription to your health insurance company (Krankenkasse). This can be done online. If in doubt, contact customer service.

  4. Receive code

    Your cash register will send you an activation code for three months (90 days) of DiGA usage. After that, you will need to submit a prescription again.

  5. Download the app

    Download the app to your mobile phone. Every DiGA is available in the google play store or app store. Some can also be used via browser.

  6. Enter code

    Where exactly you have to enter the code in the app depends on the DiGA. However, the application should query for the code itself.


What is MedTech all about?

You can read a lot about MedTech. There are websites (like disrupting healthcare), news resources, and companies focused on one thing. MedTech. But what is MedTech? What does a MedTech company do? Is Medtech in a hospital or can you have it at home, on your wrist, or inside your body?

To make your journey into the world of MedTech easier, let’s discuss basic facts about MedTech.

Photo by Natanael Melchor on Unsplash

What is MedTech?

It is just an ugly abbreviation. MedTech stands for medical technology. And as you can guess there are very many technologies in the medical sector.

What are medical technologies?

MedTech is a very wide subject, but it can be categorized into three categories.

  1. Medical Devices
  2. In-vitro Diagnostics (IVDs)
  3. Digital Health Solutions  and Digital Therapeutics (DTx)

What are Medical Devices?

Photo by Myriam Zilles on Unsplash

Medical Devices is yet another very wide term in the MedTech world. It covers any product, service, or solution used to prevent, diagnose, monitor, or treat people. As you can now understand, it can be literally anything, an instrument, appliance, software, implant, reagent, material, or even a service for processing some vital data. Under Medical Devices, you will find all known gadgets of the medical profession, syringes, needles, stethoscopes, big machines to perform X-Ray or MRI, or the special chair in your dentist. Wheelchairs and canes, and hospital beds are also medical devices. And of course, everything that can be put on or in your body in medical procedure – sensors, cardiac pacemakers, and so on.

To become a Medical Device and be used in a healthcare setting, an object or service has to meet certain regulations to ensure its safety and reliability.

What is In Vitro Diagnostics?

Photo by on Unsplash

In vitro means literally in the glass. In vitro diagnostics (IVD) is any diagnostic procedure taken outside of the patient body. It is a non-invasive test made on a sample taken from your body, used to determine the status of a patient’s health. The sample can be blood, urine, tissue, or saliva. COVID-19 tests are IVDs. IVD never comes into direct contact with a person, they provide information based on scientific measurement of the sample. IVDs are not used for treatment, they are supposed to inform patients and healthcare professionals to make decisions.

What is Digital Health?

Photo by Luke Chesser on Unsplash

Digital Health covers all tools and services that combine information and communication technologies in prevention, diagnosis, and treatment. Digital Health plays an increasingly important role in healthcare. It allows for gathering and analyzing health data on an unprecedented scale, allowing scientists to discover patterns and insights. Digital Health speeds up and facilitates research and development of new therapies. It also allows remote monitoring of vital signs, early prevention and diagnosis, and at-home or ambulatory treatment. Finally, there are specific Digital Health solutions called Digital Therapeutics (DTx). Digital Therapeutics is usually Software as Medical Device – or in layman’s terms software application, that can be prescribed and used as medicine. There are more and more such DTx available, we have been covering examples such as Deprexis and NOCD.

What is MedTech – summary

Now, you know what is MedTech! It is any technology that is used in healthcare. MedTech covers Medical Devices, In vitro Diagnostics and Digital Health Solutions. On we discuss MedTech with a focus on Digital Health on the exciting journey to improve the health and well-being of patients around the world.  

Digital Health

NOCD receives $34M funding, investors include Cigna and Kaiser Permanente

This Series B round of funding for the startup was led by Cigna Ventures and 7wireVentures, with participation from Longitude Capital, Kaiser Permanente Ventures, F-Prime Capital, Eight Roads Capital, and Health Enterprise Partners. It brings the total funding of NOCD to $84M.

NOCD – Company Overview

NOCD is the world’s leading provider of treatment for obsessive-compulsive disorder (OCD) and Community-Driven Therapy. Founded in 2018, the company aims to help get proper diagnosis and treatment to 180 million people suffering from OCD.

According to NOCD, it takes an average of 17 years for people with OCD to get proper treatment due to high costs and a shortage of specialists. NOCD offers Exposure and Response Prevention (ERP) therapy, the most proven OCD treatment, and partners with insurance plans to make it affordable. Inside the NOCD platform, patients can do live video sessions with a licensed ERP therapist, and get support between sessions from self-help tools and peer communities.

About NOCD. Source: Youtube

Stephen Smith – NOCD Founder and CEO

Stephen Smith – NOCD CEO. Source: LinkedIn

NOCD founder, Stephen Smith is himself an OCD patient. It is his own experience in the search for a diagnosis and effective treatment, that has driven him to start NOCD. Listen to the interview with Stephen Smith by Alex Wess from The Pulse by Wharton Digital Health below:

NOCD – Results so far

According to the research data, the Virtual ERP at NOCD Therapy has demonstrated clinically significant outcomes, including a 35% reduction in OCD symptom severity and an over 40% reduction in anxiety, stress, and depression symptoms.

NOCD has been successful in its coverage expansion, it is now available in all 50 States of USA and in the United Kingdom. In the US it is working with main insurance plans. The company assesses, that 2 of 3 US patients would have the service covered.

NOCD has over 300 ERP therapists and is providing more than 20,000 virtual therapy sessions per month. It also offers access to the largest online OCD community with over 100,000 community member engagements per month.

Digital Health

Meet Troy Tazbaz, a new director of the FDA Digital Health CoE

Troy Tazbaz Linkedin profile. Source: Linkedin

Troy Tazbaz has been appointed as a Director of the Digital Health Center of Excellence at the FDA. Mr. Tazbaz combines a long career in IT with long and personal involvement in healthcare.

Most media outlets focus on Mr. Tazbaz’s recent career as a cloud infrastructure at Oracle and earlier at social software Ning. For us, however, the most important is his voluntary and very personal engagement in patient care, especially in Hematology and Oncology.

Since 2010 Troy Tazbaz has been involved in campaigning for The Leukemia & Lymphoma Society, a Patient Advocacy Group, and the largest nonprofit dedicated to fighting blood cancer. Since 1949, the LLS has donated over $1.6 billion to support research on leukemia, lymphoma, Hodgkin’s disease, and myeloma.

Mr. Tazbaz has very personal experience in oncology treatment and care. He was supporting his wife, Brynn Fowler in her patient journey as documented on her blog, The Millenial with Cancer. Mrs. Fowler was diagnosed with Stage IV Colon Cancer at the age 37. Now, after Mrs. Fowler has passed away, the website is still maintained by Mr. Tazbaz as The Continuum Diaries.

FDA DHCoE Infographics. Source:

FDA Digital Health Center of Excellence is part of the Center for Devices and Radiological Health (CDRH). It is responsible for envisioning a future of safe and effective healthcare delivery with a focus on advancing public health goals with the use of technology. It performs technology evaluation, policy development, and strategic partnerships, as well as maintains a network of Digital Health experts.