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.
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: 23andme23andMe 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.
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 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 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 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 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 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 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 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 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!
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
How to get a digital health application (DiGA) in Germany?
Arrange a doctor’s appointment
It is best to let your doctor advise you on your desired DiGA DTx.
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.
Submit
Submit the prescription to your health insurance company (Krankenkasse). This can be done online. If in doubt, contact customer service.
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.
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.
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.
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.
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.
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.
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 disrupting.healthcare 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.
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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