Much of the question of FDA regulation of artificial intelligence (AI) and machine learning (ML) is seen as revolving around changes to the statute, but that does not mean the FDA and other agencies are in wait-and-see mode. Representatives of both the FDA and Health Canada said on a March 22 webinar that guidances related to these algorithms will be posted later this year, thus opening the door to a more predictable premarket path for these products.
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.
Resapp Health Ltd. saw its stock shoot up 35% on the heels of positive clinical results for its new smartphone-based COVID-19 screening test. In a pilot clinical trial of 741 patients recruited in the U.S. and India, digital health company Resapp’s screening test, which uses machine learning to analyze the sound of a patient’s cough, correctly detected COVID-19 in 92% of people with the infection.
Pear Therapeutics Inc. partnered with Softbank Corp. to bring a digital therapy for sleep/wake disorders to the Japanese market. Pear will develop the app, while Softbank will evaluate Japanese market potential with an option to negotiate an exclusive license for Pear’s Japanese sleep/wake disorder therapeutics.
At this year’s Healthcare Information and Management Systems Society (HIMSS) 2022 conference in Orlando, Fla., digital health companies across the sector gathered to showcase new products and services. HIMSS CEO Hal Wolf urged the industry to focus on global health equity and a 2022 survey of health care leaders highlighted the elements of digital transformation that are causing the biggest buzz.
Oculogica Inc. has signed an agreement with Minnetronix Inc. to launch a diagnostic device that tracks eye movements to detect possible brain concussion, this after receiving FDA clearance in December for its fourth iteration of the artificial intelligence-driven, battery-operated Eyebox.
Woebot Labs Inc. secured a $9.5 million investment from Leaps by Bayer, the impact investment arm of Bayer AG, to speed development of its artificial intelligence (AI)-enhanced behavioral health platform and digital therapeutics. The new infusion tops up Woebots fundraising, bringing its total to date to $123.5 million. The Woebot investment marks Leaps by Bayer’s first foray into mental health.
Google Health is expanding the reach of its Care Studio technology to clinical software company Medical Information Technology Inc. (Meditech). The companies reported a partnership at HIMSS 2022 to integrate search functionalities from the Google product suite within Westwood, Mass.-based Meditech's web-based Expanse electronic health record (EHR). The aim is to combine data from different sources into a standard format and offer clinicians a full ‘holistic’ view of patient records.
The FDA has cleared Royal Philips NV’s latest Philips Capsule Surveillance system, setting the stage for deployment in the U.S. Designed to stream data from almost any connected medical device, Philips Capsule Surveillance aggregates patient data, analyzes it to generate actionable insights and alerts and relays timely notifications to patients’ caregivers so they can intervene before further deterioration occurs.
Neuton Health Co. Ltd.’s virtual reality (VR)-based therapy for acrophobia has been given class II medical device approval from China’s NMPA. The VR therapy, known as Specific Fear Rehabilitation Training Software, was co-developed with the Shanghai Mental Health Center. The digital therapy company said it is the first VR device of its kind for a specific phobia approved in the world.