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FirstWord MedTech's Digital Ten is a regular round-up of the 10 most-read and noteworthy headlines related to digital health, including industry deals, alliances, collaborations, innovations and R&D news.
Sanofi teams up with consumer diagnostic start-up on smartphone-based COVID-19 test
French biopharma company Sanofi is mulling a partnership with US start-up Luminostics to co-develop a smartphone-based self-test for COVID-19 which would not require a healthcare professional to perform. The goal of this collaboration is to provide a consumer-based test that uses respiratory samples and provides results in under 30 minutes. The test would be based on Luminostics' proprietary diagnostic platform, which employs the optics in a consumer smartphone and an adapter, in combination with "glow-in-the-dark" nanochemistry and signal-processing artificial intelligence. An app would be used to instruct a user on how to run the test, capture and process data to display test results, and then to connect users with a telehealth service based on the results. Sanofi will bring its clinical research and testing capabilities to the partnership. If development and regulatory approval of the product goes smoothly, the test could be ready before the end of 2020, according to the companies.
Masimo and Samsung partner to distribute remote COVID-19 patient monitoring app
Masimo and Samsung are jointly developing the Masimo SafetyNet patient app designed to help clinicians care for patients remotely in both hospital and non-traditional settings. The app will be made available on select Samsung smartphones, pre-installed and pre-configured, to allow for broader, faster distribution to COVID-19 patients, especially older patients who are less likely to own a smartphone or to configure the app on their own. The app will be paired with Masimo’s tetherless, wearable single-patient-use SET sensor to monitor a patient's blood oxygen saturation and pulse rate, as well as respiration rate, perfusion index, and PVi (Pleth Variability Index, a measure of the dynamic changes in the Perfusion Index that occur during one or more complete respiratory cycles). It is designed to help manage the surge in COVID-19 patients while maintaining distance from other patients and providers, allowing hospitals to expand patient remote monitoring into alternative care spaces, including overflow locations, emergency recovery facilities, skilled nursing facilities, and home care settings.
Wearables make their mark in COVID-19 battle
Masimo isn't the only company whose wearable technology is being used in the fight against COVID-19. In the area of diabetes care, Abbott’s Freestyle Libre and Dexcom’s G6 are among the wearable continuous glucose monitors given special authorisation by the FDA for use in hospitalised COVID-19 patients to enable healthcare workers to take blood glucose readings quickly without coming into contact with these patients. Several companies are also developing continuous temperature monitors for tracking fevers in COVID-19 patients and in non-infected groups who might be at high risk of contracting the virus. Read our feature, Spotlight On: Beyond Ivds And Ventilators - Medtech’s Multifront Battle Against Covid-19, highlighting these and other wearable technologies that are in the market or being developed to help fight the ongoing pandemic.
Emerging digital health companies consolidate
Recognising the opportunity in remote monitoring and wearable technologies, not just during the COVID-19 pandemic but in the long term, Huma (formerly known as Medopad) has acquired two emerging companies to bulk up its digital health offerings. BioBeats is developing an app-and-wearable platform, Biobase, for managing mental health, while TLT is developing a cuffless, wearable continuous blood pressure monitoring device. Both companies, like its acquirer Huma, are based in the UK. Huma specialises in remote monitoring apps, and have developed a COVID-19-specific app.
Biofourmis acquires Takeda’s Gaido for digital oncology care
Biofourmis has acquired from Takeda’s venture investment arm a portfolio company specialising in the remote care of patients discharged from hospital after cancer treatment, such as CAR T-cell therapy. Gaido Health’s platform combines information on patients’ vital signs collected via remote monitoring in the home, patient surveys and analytics to detect early signs of complications caused by potential toxicities. The platform will be integrated into Biofourmis’ Biovitals analytics engine, which was FDA-cleared last year as a medical device for ambulatory physiological monitoring.
AI deployed to fast-track COVID-19 drug research
The use of artificial intelligence for accelerating drug discovery is now being applied to COVID-19 in hope of speeding up the development of a viable vaccine. Japanese IT giant NEC is among the companies working in this area, with the recent announcement that it has used its AI prediction platform - initially used to develop personalised neoantigen cancer vaccines - to design blueprints for SARS-CoV-2 vaccines that can drive potent T-cell responses in the majority of the global population. The team at NEC used these prediction algorithms to scan for epitopes (potential vaccine targets) across the entire repertoire of proteins in SARS-CoV-2, not only the spike surface protein, and used this data to identify "hotspots" in the viral proteome that contained overlapping and co-located epitopes from multiple HLA-alleles. The optimal constellation of "hotspots" was then selected by their algorithms to generate the optimal immune response with the broadest coverage of the human population, whilst prioritising hotspots that occurred in conserved regions of the viral proteome. These conserved regions are less likely to mutate in future strains, according to NEC.
FDA widens availability of digital therapeutics for psychiatric disorders during COVID-19
Consistent with its objective to ease patients’ access to the medical treatment they need during the COVID-19 pandemic, the US FDA has issued guidance to help expand the availability of low-risk, clinically-validated digital therapeutic programmes and devices for mental health and psychiatric disorders. These would encompass apps and online programmes to help manage depression, alcohol use disorder, anxiety, insomnia, suicidality, autism, attention deficit hyperactivity disorder, obsessive compulsive disorder, and post-traumatic stress disorder. Under this policy, the FDA indicated it "does not intend to object to the distribution and use of computerized behavioral therapy devices and other digital health therapeutic devices for psychiatric disorders" - even if they have not yet been officially cleared by the regulator - for the duration of the COVID-19 public health emergency.
Akili releases digital therapeutic for ADHD under FDA's relaxed policy
Akili has temporarily made its digital therapy for attention-deficit hyperactivity disorder (ADHD), ENDEAVOR, available to children at no cost and without a physician prescription, following the FDA’s new policy allowing the distribution of such digital therapies for psychiatric disorders during the COVID-19 pandemic. Akili had submitted ENDEAVOR last year to the FDA to get 510(k) clearance as a prescription treatment for use in paediatric ADHD. The app, which is based on gamification principles, will ultimately require 510(k) clearance, but this temporary release should provide the company with "highly valuable insights relevant for the commercial launch of the product further down the line," according to analysts.
Happify launches portal for faster mental health referral
Capitalising on the increasing demand for remote self-care, Happify Health has launched Happify Connect, a new screening and referral hub that makes it easier for employees and health plan members to immediately access the mental health support they need. The referrals are personalised to the individual and based on clinical assessment and pre-defined triggers. Happify’s signature app is designed to manage depression and anxiety; last year, the company inked a deal with Sanofi to develop digital therapeutics for multiple sclerosis patients that address co-morbidities related to mental well-being.
First speech therapy app gets FDA breakthrough device designation
The FDA has granted breakthrough device designation to The Learning Corp’s Speech Therapy (ST) app, the first cognitive linguistics app to be given such a status. The ST app is designed for rehabilitating stroke patients, helping them to improve their cognitive, speech and language abilities. It is a home-based digital therapy, driven by artificial intelligence, that allows clinicians to check in remotely on the patient’s progress.
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