Category: Digital Health

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Digital Health MedTech

EU Digital Health Funding Landscape 2025: Where and How to Raise Capital in Europe

With over €20 billion in public and private capital flowing into digital health ventures since 2020, the European Union has become a strategic launchpad for healthtech founders. But where exactly does this capital come from? And what’s the smartest path for early-stage startups looking to digital health funding?

This in-depth guide breaks down the EU digital health funding landscape in 2025 — covering both EU-level grants (like Horizon Europe, EU4Health, and the EIC Accelerator) and national innovation programs (from France’s Bpifrance to Germany’s HTGF). We also map out the private funding scene, spotlighting active VCs and corporate funds, and show how EU regulations like MDR and GDPR influence access to capital.

Whether you’re applying for your first public grant, looking to raise a blended round, or building a scalable platform for regulated care — this guide is for you.

The Big Picture: Why EU Digital Health Funding Matters in 2025

In 2024 alone, startups in Europe raised $4.8 billion in digital health VC — a 27% YoY increase (Galen Growth). Mega-rounds like Alan (€193M), Ōura (€200M), and Flo Health ($200M) highlighted the growing maturity of the region.

Public funding is also expanding. The European Commission committed over €14 billion to digital health via Horizon Europe, EU4Health, and the Digital Europe Programme. Countries like France, Germany, and the Nordics doubled down on national programs for startups, especially those focused on regulated innovation (e.g. DTx, AI diagnostics, RPM).

But with increased capital comes increased complexity: understanding how to access the right programs, meet regulatory expectations, and position your startup for both grants and venture capital is essential.

EU-Level Public Funding: Key Programs for Startups

1. Horizon Europe

The EU’s flagship R&D program with a €95.5 billion budget, Horizon Europe funds large-scale innovation consortia. While not startup-specific, early-stage digital health ventures can access funds by partnering in consortium projects (e.g. under Cluster 1: Health).

Pro tip: Join a consortium via national contact points or through platforms like CORDIS.

2. EIC Accelerator

For high-risk, high-impact innovation, the EIC Accelerator offers up to €2.5M in grant + €15M in equity. In 2024, only 71 out of 1,211 applicants (≈5.9%) were selected (EIC Results).

Eligible: single startups incorporated in the EU.
Selection: based on scalability, scientific merit, and impact.

3. EU4Health

A €4.4 billion program supporting digital infrastructure, health data, and cross-border health services. Includes funding for the upcoming European Health Data Space (EHDS).

Best fit: startups providing EHR, interoperability, cybersecurity, or public health software.

4. Digital Europe Programme

Targets adoption of digital capabilities like AI and cybersecurity. Useful for startups bridging research and deployment.

National-Level Public Funding: Country Breakdown

France – Bpifrance and France 2030

  • Over €2.3B deployed into health innovation via Bpifrance since 2021.
  • Grant programs: i-Lab, i-Nov, French Tech Emergence.
  • Digital Health Acceleration Strategy under France 2030.

Germany – High-Tech Gründerfonds (HTGF)

UK – Innovate UK

  • Smart Grants up to £2M.
  • Health-specific challenges (e.g. mental health, aging tech).
  • Access to NHS pilots via NIHR, NHS Innovation Accelerator.

Nordics (Finland, Sweden, Denmark, Norway)

  • Innovation agencies (e.g. Business Finland, Vinnova) offer R&D grants, public co-investment.
  • Highly digital healthcare systems ideal for pilots.

CEE (Poland, Estonia, Czechia, etc.)

  • Heavy use of EU structural funds via EIT Health and local programs.
  • Lower VC volumes but rising interest from pan-European funds.

Private Capital: VC and Corporate Investors in Digital Health

Top early-stage investors active in EU digital health (2024–2025):

VC/InvestorHQNotes
BpifranceFRPublic VC, top deal count in Europe
Octopus VenturesUKHealthtech-focused team, 7 deals in 2024
Heal CapitalDEBacked by German insurers
MTIPCHDigital health scale-up investor
Nina CapitalESSpecialized in early-stage health tech
Khosla VenturesUSActive in EU AI health rounds
Wellington PartnersDEKnown for Temedica, Kaia Health

EU Regulations and Their Impact on Fundraising

MDR (Medical Device Regulation)

If your product qualifies as a medical device (e.g. AI diagnostics, digital therapeutics), you must comply with MDR to enter the EU market.

Pro tip: CE-marked startups are more likely to receive both VC and public funding.

GDPR (General Data Protection Regulation)

Strong privacy and data governance are mandatory. Consider external audits, ISO27001 certification, and working with GDPR Sandboxes in countries like France or Spain.

EHDS (European Health Data Space)

Coming 2025, EHDS will define interoperability and data-sharing standards across Europe. Compliance could unlock access to new tenders and cross-border pilots.

2025 Outlook: Trends and Opportunities

  • AI dominance: ~60% of 2025 funding so far went to AI-driven health ventures (CB Insights).
  • Public-private blending: More startups combining EU grants + VC in same round.
  • Reimbursement as ROI: Germany (DiGA), France (PECAN), and Nordics offer clear digital reimbursement paths — critical for Series A+ readiness.
  • CEE Rising: Low costs + EU funds = surge of new startups in Poland, Romania, Hungary.

FAQs

What are the best EU digital health funding programs for early-stage startups?

Top options: EIC Accelerator, EU4Health, national innovation agencies (Bpifrance, HTGF), and Digital Europe grants for AI/infra.

How competitive are EU public grants?

Highly. For example, the EIC Accelerator had ~5.9% success in 2024 (source). “Seal of Excellence” can still unlock national funds.

Which EU country is best for starting a digital health company?

France (strong grants), Germany (DiGA reimbursement), UK (private VC and NHS pilots), Nordics (public adoption), and Poland (cost and EU access).

Want to go deeper into commercialization, regulatory strategy, or fundraising? Explore our insights on how Bigfoot Biomedical built a commercial model around a digital-first insulin delivery system and why Pear Therapeutics failed to secure sustainable revenue despite FDA-approved DTx.

This content has been enhanced by GenAI tools.

Categories
Digital Health MedTech

What Happened to 23andMe? The Rise, Fall, and Future of a Consumer Genetics Pioneer

23 and me kit

Understanding the 23andMe Journey

23andMe was founded in 2006 by Anne Wojcicki, Linda Avey, and Paul Cusenza with a bold vision: to put the power of genetics directly into the hands of consumers. The startup pioneered the direct-to-consumer (DTC) genetic testing market, offering affordable at-home DNA test kits that could reveal ancestry roots, inherited traits, and potential health risks.

The company made headlines early on with its $999 saliva-based DNA test, which later dropped to $99—making it accessible to millions. For the first time, individuals could decode their DNA without going through a doctor or lab. This democratization of genetic data made 23andMe a household name and a Silicon Valley darling.

But with innovation came regulatory friction. In 2013, the U.S. Food and Drug Administration (FDA) halted the marketing of 23andMe’s health reports, citing concerns over accuracy and consumer safety. After years of negotiations, the company received FDA clearance in 2017 for specific health risk reports, such as predispositions to Parkinson’s and Alzheimer’s.

The Business Model Shift

23andMe wasn’t just selling DNA kits—it was building a data-driven biotech engine. Over time, it accumulated one of the largest genomic databases in the world. This treasure trove of anonymized genetic data became a valuable asset for pharmaceutical research.

Image: GSK’s 2018 partnership with 23andMe marked a major turning point for the company’s therapeutics ambitions.

In 2018, 23andMe announced a high-profile partnership with GlaxoSmithKline (GSK), aiming to develop new drugs using its consumer data. The move signaled a pivot from consumer health to therapeutics.

The company went public in 2021 via a SPAC merger, reaching a valuation of nearly $3.5 billion. It was a landmark moment, but also the peak of its trajectory.

Why Did 23andMe File for Bankruptcy?

In early 2025, 23andMe filed for Chapter 11 bankruptcy protection—a stunning development for one of health tech’s most iconic players.

The reasons behind the collapse are multifaceted:

  • Declining demand for consumer DNA tests as the novelty wore off
  • Privacy concerns and increased scrutiny over genetic data usage
  • Limited success from the GSK partnership, with no therapies reaching late-stage trials
  • Rising operational costs amid a tougher funding environment for biotech startups

The consumer genetics market matured and contracted. With fewer new customers and limited revenue from therapeutics, 23andMe faced an unsustainable business model.

The Chapter 11 filing offers a path to restructure. However, it remains unclear whether the company will recover, pivot again, or sell off its most valuable asset—its genomic database.

Who Is Anne Wojcicki?

Anne Wojcicki, born in 1973, is the co-founder and CEO of 23andMe. A biology graduate from Yale, Wojcicki began her career as a healthcare investment analyst before disrupting the world of genomics.

She envisioned a more transparent, consumer-centric healthcare model—one where individuals could access and understand their own genetic code. Her leadership helped push personalized medicine into the mainstream.

Wojcicki is a prominent advocate for digital health, women in STEM, and healthcare innovation. She was formerly married to Google co-founder Sergey Brin and is the sister of former YouTube CEO Susan Wojcicki.

Even as 23andMe faces restructuring, Anne Wojcicki remains a powerful voice in biotech, known for challenging traditional healthcare and betting on the future of data-driven medicine.

Subscribe to Disrupting.Healthcare for more insights into MedTech, digital health trends, and the companies shaping the future of care.

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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.

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Digital Health MedTech

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

pear therapeutics bankruptcy (https://peartherapeutics.com/)
Pear Therapeutics bankruptcy (https://peartherapeutics.com/)

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

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.

Conclusion

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.

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Digital Health MedTech

Bigfoot Medical: Pioneering Diabetes Management Solutions & Their Future Prospects

BigFoot Unity (www.bigfootbiomedical.com)
BigFoot Unity (www.bigfootbiomedical.com)

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.

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Digital Health MedTech

The Top 10 Medical Devices Types Revolutionizing Digital Health in 2023

man woman internet connection
Photo by Darlene Alderson on Pexels.com

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!

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Digital Health

Germany leading in DTx reimbursement with 42 DiGA-approved apps

DiGA directory - screenshot
DiGA directory - screenshot

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.

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Digital Health

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

NOCD logo and graphics. Source: Youtube
NOCD logo and graphics. Source: Youtube

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.

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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.gov

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.



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Digital Health

Artificial Intelligence and Machine Learning (AI/ML) in Medical Devices

Do you know that FDA already approved 521 Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices?  

PAPNET. The failure of the pioneering AI/ML-enabled test.

Five hundred apps may not surprise you in January 2023, given the noise around Open AI and its GPTChat. However, the first such device, PAPNET Testing System, was approved over 28 years ago. In 1995, the year of Johnny Mnemonic and Ghost in the Shell movies!

Fig.1 Neural net-based (PAPNET, Neuromedical Systems, Suffern, NY) display of squamous cells (Papanicolaou stain) from a balloon smear showing effects of radiotherapy. Marked cell enlargement and vacuolization of cytoplasm are easily recognized.
Source: Koss, Leopold & Morgenstern, Nora & Tahir-Kheli, Naveed & Suhrland, Mark & Schreiber, Katie & Greenebaum, Ellen. (1998). Evaluation of Esophageal Cytology Using a Neural Net–Based Interactive Scanning System (the PAPNET System): Its Possible Role in Screening for Esophageal and Gastric Carcinoma. American journal of clinical pathology. 109. 549-57. 10.1093/ajcp/109.5.549.

PAPNET was using a neural network to analyze and interpret cytology from Pap smears. While this early system generated a lot of interest and Google Scholar lists 217 peer-reviewed articles on PAPNET results, the business side of it was not that great. The cost-effectiveness of the system in comparison to manual screening by cytotechnician was not there. Neuromedical Systems Inc, the company behind PAPNET went bust in 1999, and now its intellectual property is a part of Becton, Dickinson and Company portfolio.

List of FDA-approved Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices

If you look at the list of approved AI/ML-enabled medical devices, you will notice that the vast majority (392 medical devices, 75% of the whole) are for Radiology. Cardiovascular (57,11%), Hematology (15, 3%), and Neurology (14, 3%) are the remaining three significant categories.

Fig. 2: Split of approved AI/ML-enabled medical devices by Specialty Panel.
Source: FDA.gov, graphics by disrupting.healthcare

There are only 15 companies that have more than five AI/ML-enabled medical devices approved. Five of those companies are actually subsidiaries of GE, which in total owns 42 AI/ML-enabled medical devices. Then there is Siemens with 27 devices, Canon with 15, Aidoc Medical with 13, and Zebra Medical Vision with 9 devices. Philips, which also submitted its devices via different subsidiaries has in total 10 approved AI-enabled devices

Table 1. Companies with over 5 approved AI/ML-enabled medical devices
CompanyAI/ML-enabled medical devices
GE Medical Systems42
Siemens Healthineers27
Canon17
Aidoc Medical13
Philips Healthcare10
Zebra Medical Vision9
Quantib BV6
Arterys Inc.5
Clarius Mobile Health Corp.5
HeartFlow, Inc.5
RaySearch Laboratories AB5
Viz.ai, Inc.5
Source: FDA.gov, disrupting.healthcare

The future of AI-enabled and data-driven MedTech

The market for Artificial Intelligence / Machine Learning – enabled Medical Devices seems to be poised for growth. At a recent HLTH 2022 conference in Las Vegas, Michelle Wu, CEO of NyquistData, a company offering an AI-supported intelligence platform dedicated to MedTech companies discusses the advantages of using AI to unlock the potential of unstructured data from medical devices.

Leveraging Artificial Intelligence, Data to Improve Medical Devices
Source: Xtelligent Healthcare Media

Cleerly. An example of an AI-enabled medical device for a heart-attack-free future.

A good example of upcoming Artificial Intelligence / Machine Learning – enabled Medical Device may be Cleerly. The startup has raised $279 million from investors including Fidelity, T. Rowe Price, Novartis and Peter Thiel.

Founded by cardiologist James Min, former professor at Weill Cornell Medical College and director of the Dalio Institute of Cardiovascular Imaging at New York-Presbyterian, Cleerly uses AI to improve diagnostics cutting down on the time it takes to flag patients at risk.

Its proprietary AI algorithms analyze CCTA images to generate a 3D model of patients’ coronary arteries, identify their lumen (the cavity or channel within a tube or tubular organ such as a blood vessel) and vessel walls, locate and quantify stenoses, as well as identify, quantify and categorize plaque.

Source: Cleerly