The Medical Device Innovation Consortium (MDIC) has launched a digital health initiative that will aid the FDA in its efforts to devise a workable regulatory system for these products, which includes a work stream for change control. This work stream promises to be a massive effort, but Joe Sapiente, MDIC's vice president for clinical science and technology, told BioWorld that MDIC needs subject matter experts in this and several other areas to sustain the group’s momentum and thus aid the FDA’s efforts to produce guidance for digital health products.

The FDA has designated Impedimed Ltd.’s Sozo digital health platform a breakthrough device for renal failure, paving the way for the first FDA approved device to measure fluid volume in the dialysis setting.

LONDON – Ibex Medical Analytics Ltd. has claimed a further advance in applying artificial intelligence (AI) to the interpretation of digitized pathology slides, reporting that the first commercial system in the world using AI to detect gastric cancers has gone live. The Galen Gastric system has been deployed at the pathology lab of Maccabi Healthcare Services, one of Israel’s leading HMOs, where it is now operational alongside Ibex’s breast and prostate cancer AI systems.

Vuno Inc. received approval from South Korea’s Ministry of Food and Drug Safety (MFDS) for Vuno Med Deepcars, its artificial intelligence (AI) medical device for cardiac arrest prediction. Approval in hand, Seoul-based Vuno will push for wider adoption of its biosignal-based AI technology. Vuno Med Deepcars predicts the probability of cardiac arrest occurring within a 24-hour period by analyzing a patient’s pulse, respiratory rate, diastolic and systolic blood pressure as well as body temperature. The data is collected from the electronic medical record of hospitalized patients.

Digital health has made only limited headway in the orthopedics space, but Zimmer Biome Inc. and Canary Medical Inc. have nudged the cause along with a smart implant that blends a 21st century sensor with a traditional knee replacement device. The marriage of Zimmer’s Persona knee implant and the Canary Medical Canturio TE sensor will give physicians a better way to track the patient’s recovery from knee replacement procedures.

PARIS – Researchers from the department of radiation oncology at the European Hospital Georges Pompidou (HEGP) and Stanford University School of Medicine have together developed a new artificial intelligence (AI) prediction tool for patients diagnosed with prostate cancer. These researchers have just published a validation of this interpretable AI model in Cancers. “It’s a question of distinguishing patients at risk of mortality from aggressive cancer that is spreading rapidly, from patients who might have far less aggressive cancer and who are not likely to die from it in under 10, 15 or even 20 years,” Jean-Emmanuel Bibault, radiotherapy oncologist at HEGP, told BioWorld.

The FDA has issued an emergency use authorization (EUA) for Becton, Dickinson & Co.’s (BD) Veritor At-Home COVID-19 test – a rapid COVID-19 digital antigen test. The test, which is designed for home use, uses a mobile app from Los Angeles-based Scanwell Health Inc. that provides instructions on how to collect and transfer the nasal swab sample to the test stick. The smartphone camera is then used to capture, analyze and interpret results within 15 minutes. BD said it will initially be rolled out to businesses, schools and governments looking to provide a self-testing option.

The use of voice recognition systems based on artificial intelligence (AI) in health care is emerging in India, which offers a potentially enormous market, according to Scribetech Healthcare (India) Pvt. Ltd., one of the leading voice recognition companies in the country.

Better Therapeutics Inc. has closed on a $50 million debt facility that advances the company’s push into the market for digital therapeutics for type 2 diabetes, a market that seems poised to expand drastically in the next few years. The $50 million debt facility by Hercules Capital is just one of several important financial benchmarks for Better, which is also planning to go public thanks to a merger with a special purpose acquisition company (SPAC) that may raise well in excess of $100 million, all of which seem to promise a bright future for Better and those with type 2 diabetes.

PERTH, Australia – The Australian government is investing AU$79 million (US$56.75 million) in medical research and innovation projects to develop new drugs, devices and digital health technologies through its AU$20 billion Medical Research Future Fund (MRFF).