Roche Diagnostics International Ltd. is joining forces with Bristol Myers Squibb Co. (BMS) to develop two new digital pathology algorithms to support cancer assay use in clinical trials. Roche Digital Pathology will create an artificial intelligence (AI) based image analysis algorithm to assist pathologists in interpreting the company’s FDA-approved Ventana D-L1 (SP142) assay for urothelial carcinoma patients. BMS will use the algorithm to generate biomarker data from clinical trial samples.
SK Biopharmaceuticals Co. Ltd.'s three-pronged plan for tackling epilepsy is going strong, with lead drug cenobamate for drug-resistant focal-onset seizures nearing the finish line, and earlier-stage programs for a mRNA-based approach and a digital therapeutic in the works.
Digital health company Recora Inc. has surfaced from stealth mode with $20 million in series A funding to advance its comprehensive care management vision for heart disease patients.
Astrazeneca plc is selling its disease management platform Amaze to U.K. digital therapeutics company Huma Therapeutics Ltd. through a new collaboration agreement. The companies said they will work together to launch Software as a Medical Device (SaMD) companion apps for several therapeutic areas and accelerate adoption of decentralized clinical trials (DCTs). The partnership marks Astrazeneca’s first major deal in the digital health space.
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.
RSS
