Highlights & Summary
The last quarter of 2021 was filled with exciting regulatory approvals, product launches, partnerships, and acquisitions for the digital health space. We’ve rounded up the big headlines for you.
Overarching / Misc.
- FDA hopes draft guidance on device software will offer 'clarity, simplicity'
Regulatory Guidance | FDA
AI / Imaging
- Roche announces PathAI collaboration for artificial intelligence-based digital pathology applications for improved patient care
Partnership | Roche, PathAI
- Akoya Biosciences Announces a Groundbreaking Collaboration with PathAI to Combine Spatial Biology with AI-Powered Tools to Facilitate Discovery of Novel Predictive Biomarkers
Partnership | Akoya Biosciences, PathAI
- Royal Philips scores 510(k) for Liver Fat Quantification tool
Regulatory Approval | Royal Philips
- PrecisionOS receives FDA 510(k) approval for VR surgical planning tool
Regulatory Approval | PrecisionOS
Disease Management / Digital Therapeutics
- AppliedVR’s EaseVRx scores FDA De Novo clearance for treating chronic lower back pain
Regulatory Approval | AppliedVR
- Pear Therapeutics receives FDA breakthrough device designation to treat alcohol use disorder with its prescription digital therapeutic
Clinical Trial Launch | Grail
- Kry to roll-out digital mental health service across Europe
Product Launch | Kry
- Lyn Health emerges from stealth with platform for managing multiple chronic conditions
Product Launch | Lyn Health
Informatics / Healthcare IT Solutions
- Oracle snags Cerner in $28B mega deal to make a big move into healthcare
Acquisition | Oracle, Cerner
- AI-based assessment platform Ada Health joins forces with pharma giant Bayer
Funding | Exai Bio Partnership | Ada Health, Bayer
- Philips receives FDA 510(k) clearance for its most advanced acute patient monitors
Regulatory Approval | Philips
- Introducing the Truveta Platform: Unprecedented De-Identified Health Data Refreshed Daily with New COVID-19 Insights
Product Launch | Truveta
- Phreesia Acquires Insignia Health to Improve Patient Experience
Acquisition | Phreesia, Insignia Health
- MyRx.io launches to offer prescription management, price transparency
Product Launch | Prescryptive Health
Overarching Industry Updates
1 | FDA hopes draft guidance on device software will offer 'clarity, simplicity'
The FDA published draft guidance for software in a medical device and software as a medical device, in order to replace the current medical device guidance, which was issued over 16 years ago. The draft–which will apply to devices used in combination products, devices used in certain blood donor applications, Class III devices, and devices in which a software fault presents a probable risk of serious injury or death–outlines risk-based basic and enhanced documentation levels and their respective requirements. Basic-level devices do not require any information relating to Software Design Specifications (SDS), but enhanced-level devices must provide “the complete documentation, including sufficient information that would allow FDA to understand the technical design details of how the software functions."
AI / Imaging
Roche, a global leader in pharmaceuticals and diagnostics, and PathAI, a leader in artificial intelligence for pathology, have entered into a collaboration to develop image analysis workflow solutions for pathologists. PathAI’s image analysis algorithms will be applied to Roche’s uPath software for multiple cancer types to derive impactful diagnostic insights. This partnership will accelerate commercialization of AI based digital pathology and support biopharmaceutical partners by combining assays, scanners, image management systems, and AI algorithms into one end-to-end solution necessary for CDx development.
Akoya, an industry leading company in spatial biology, and PathAI, a leader in artificial intelligence for pathology, announced their collaboration in order to apply PathAI’s analytical capabilities to Akoya’s spatial phenotyping platform. This collaboration will provide a complete solution for biopharma partners to accelerate the discovery and validation of novel biomarkers, enhancing the partners ability to determine which patients are more likely to respond to the IO therapies being used in clinical trials.
Royal Philips announced that as part of the latest release of its ultrasound systems, EPIQ Elite and Affiniti, they have received 510(k) clearance for their liver fat quantification tool. This tool allows for a non-invasive diagnosis of non-alcoholic fatty liver disease (NAFLD). NAFLD is estimated to be present in about 25% of the global population. Previously the standard of care was traditional gray scale imaging, which would allow a radiologist to tell if the liver had a high degree of fat or normal. With more specific quantification the disease can be determined as mild, moderate, or severe, allowing for earlier intervention and diagnostic confidence, as well as better data for performing research on liver disease progression. Improved non-invasive imaging of liver fat content could be an important tool in identification, stratification, and monitoring of patients for NASH treatments, which many pharma companies are racing to develop.
The 510(k) clearance for the InVisionOS tool will allow surgeons to project a 3D construction of a CT scan on patients for planning surgery. Using the Oculus Quest 2 virtual reality device (from Meta, formerly Facebook), the surgeon can focus on specific anatomical regions before surgery. This can improve confidence and competency of surgeons to benefit patient outcomes by allowing surgeons to see the CT scan in real time instead of carrying a mental model from a computer screen to the OR.
Disease Management / Digital Therapeutics
AppliedVR has received FDA De Novo clearance for EaseVRx, a virtual reality system that treats chronic lower back pain. This news comes just after it raised $36 million in Series B funding. The virtual reality system includes a VR headset, controller, and “Breathing Amplifier” used to train the patient in deep breathing. A series of 56 VR sessions uses cognitive behavioral therapy to treat pain, offering exercises in breathing, mindfulness, relaxation-response, and executive function. Researchers report that 66% of EaseVRx users reported >30% reduction in pain, compared to only 41% of users in the control group.
Pear Therapeutics, Inc., received a Breakthrough Device Designation (BDD) for its reSET-A™ prescription digital therapeutic (PDT) for the treatment of alcohol use disorder (AUD) ahead of its merger with Thimble Point. The BDD is Pear’s second following the recent designation for their reSET-O™ for the treatment of opioid use disorder (OUD). The PDTs are based on cognitive behavioral therapy for outpatients being treated for substance abuse. Approximately 14 million adults in the US aged 18 or older suffer from AUD in 2019, yet there are few treatment options for AUD with less than 10% of diagnosed individuals receiving any treatment and a resulting $7.6 billion in annual hospital medical costs. PDT’s such as reSET-A™ provide an easily accessible and much needed routine treatment for substance abuse illnesses such as AUD and OUD.
Kry, a digital healthcare firm, will implement its internet cognitive behavioural therapy (ICBT) program throughout Europe following a $300 million Series D funding round. The ICBT is accessible through the Krya app on smart devices and allows users to book treatment for depression, anxiety, and other mental health disorders. A recent study by the University of Sheffield’s Centre for Psychological Services Research in the UK found that depressed patient’s patient health questionnaire (PHQ-9) scores improved significantly over a 8-12 week treatment period comparable to traditional in-person cognitive behavioral therapy, representative of an emerging trend throughout Europe for the regulatory approval and implementation of ICBT services for digital treatment of mental health disorder patients.
Backed by Summer VC, Lyn Health emerges from stealth and plans to officially launch early 2022. Its main offering is a platform that helps manage multiple chronic conditions such as heart disease, diabetes, and arthritis by working with health plans, employers, and providers. The platform will act as a single point of contact that patients can access virtually at any time and help with managing medications and providing behavioral health support. Lyn Health has recently hired Brian Marcotte, former President and CEO of Health Business Group, to its board of advisors.
Informatics / Healthcare IT Solutions
Oracle intends to acquire Cerner in a deal valued at $28.3 billion in a move to grow its presence in the healthcare industry. Setting the record for the biggest deal in Oracle history, this acquisition will further entrench Oracle technology in healthcare and be a step towards expanding this technology in countries throughout the world. With the acquisition, Oracle also expressed intentions to create a new generation of digital tools to allow easier access to information via a hands-free voice interface to secure cloud applications. An official filing with the U.S. SEC has been made, and the merger awaits regulatory approval.
AI-based platform Ada Health partners with Bayer to offer a digital solution to help people be more proactive about preventative care. They will release a free app that provides personalized insights and actionable advice via AI chatbot to help advise people on health issues they may think are too insignificant to warrant a doctor’s visit. It will work much like a WhatsApp chat with a trusted doctor and will be available 24/7. Timely detection of disease can shorten the time to diagnosis and connect patients with appropriate care.
Philips receives 510(k) clearance for its most advanced acute patient monitors yet, the MX750 and MX850, which received the CE mark in 2019. Data can flow seamlessly between these patient monitors and the Philips Acute Care Telehealth command center, which will help simplify clinical workflow and help care teams better manage patient care.
Truveta introduced the Truveta Platform, which offers unprecedented real-time de-identified clinical data from 10,000+ care sites across 42 states. This dataset represents a massively diverse cut of the country across age, geography, race, ethnicity, and gender. The first insights shared via the platform are COVID-19-related, most notably that 9-15% of people with breakthrough infections are hospitalized, with J&J patients having the highest rate of hospitalized breakthrough infections (15%).
Phreesia has announced it is acquiring Insignia Health as part of Phreesia’s efforts to empower patients to be active participants in their care. Insignia Health holds a worldwide license for PAM (patient activation measure), which has results that show it can be used to improve risk identification, guide patient support, and evaluate impact as a patient-reported outcome measure. Phreesia considers Insignia Health’s PAM the gold standard for patient activation measures and hopes to leverage it in the future.
Prescryptive Health, a health tech company, has launched MyRx.io, a mobile platform that provides users access to pharmacy services such as finding prescription benefit information, medication shopping, and vaccination appointment scheduling. In the U.S., 8 in 10 adults say prescription drug prices were unreasonable, and an A RAND Corporation report found that U.S. drug prices are more than 2.5 times higher than those seen in 32 other countries. MyRx.io is a solution amongst others such as GoodRx whose aim is to make prescription drugs more accessible and their prices more transparent.
Headlines are curated by Olivia Qiu, Lauren Brodsky, and Alex Amram.