France is tightening access to the reimbursed health care market for digital medical devices. The national Digital Healthcare Agency (ANS) reported that a standard interoperability and safety system for digital medical devices is coming into force.
German regulators have unveiled their initial report covering the prescription and deployment of reimbursable health apps. The survey was carried out by Hamburg-based health insurance fund Techniker Krankenkasse (TK) in conjunction with Bielefeld University in North Rhine-Westphalia and health care economics analysis research bureau Vandage GmbH, also based in Bielefeld.
The U.S. FDA handed good news to Healthy IO Ltd. (Healthy.io) with 510(k) clearance for its smartphone-based Minuteful Kidney test, making kidney function testing – from sample to result – possible at home. The app calculates the albumin-to-creatinine ratio (ACR), a key indicator of kidney disease. By enabling people to complete the test using their phones, the company says it has increased the rate of testing in high-risk patients by 50%.
The U.S. Federal Trade Commission (FTC) has been moving aggressively on privacy issues in connection with health data in the past two years, but the agency has issued an advisory of sorts to collectors of these data points. The FTC said July 11 that it intends to crack down on violators in an effort to protect data privacy.
Kranus Health GmbH has raised $6.5 million in series A funding to ramp commercialization of its digital therapy for treating erectile dysfunction (ED). Eleven European investors participated in this fundraising. The round was led by early-stage health care venture capitalists Karista SAS, while Peak Pride Management GmbH also joined the funding round.
The U.S. FDA has given Resapp Health Ltd. the green light for its 510(k) Sleepcheckrx app to detect moderate to severe sleep apnea in adults as a prescription-only software-as-a-medical device. The FDA cleared the app as a class II medical device. Brisbane, Australia-based Resapp submitted the 510(k) premarket notification to the FDA in November 2021 for Sleepcheckrx for at-home sleep apnea screening.
Envision Technologies BV’s latest artificial intelligence (AI)-powered smart glasses for the blind and visually impaired are designed to help with reading, scanning faces and navigating everyday tasks. This visual assistant was introduced at California State University Northridge (CSUN) 2022 Assistive Technology Conference. Envision has updated its AI-based platform and ecosystem with improved optical character recognition (OCR) and better text recognition with contextual intelligence.
Ceros Capital Markets and Peregrine Ventures evidently liked what they heard about Cordio Medical Ltd.’s Hearo voice app that can detect deterioration in patients with congestive heart failure (CHF), leading them to invest $18 million in the company’s latest venture funding round.
Results from a new peer-reviewed study show people develop emotional bonds with artificial intelligence (AI) therapy chatbots in a similar way to in-person therapists. The study evaluated 1,205 people using a mental health app developed by Wysa Ltd. to assist symptoms of anxiety or depression. The chatbot guides users through therapy exercises including cognitive-behavioral techniques (CBT), dialectical behavior therapy, meditation, breathing and yoga to build mental resilience skills.
Eko Devices Inc. launched a redesigned app and smart stethoscope system to detect heart disease during a regular physical, potentially reducing the time to diagnosis and treatment for America’s number one killer. The system incorporates artificial intelligence (AI) to identify heart murmurs and atrial fibrillation with performance the company says is on par with cardiologists.