Eko Devices Inc. said Tuesday that it is collaborating with British pharma giant Astrazeneca plc to speed the development of digital health tools to improve early detection of cardiovascular diseases, including heart failure. The partnership could lead to more personalized care for heart failure patients, improving long-term outcomes.
The Trump administration has issued an executive order designed to improve access to telehealth for Medicare beneficiaries in rural America, making permanent numerous changes that had been temporarily added for the COVID-19 pandemic. The news arrives as the Centers for Medicare and Medicaid Services (CMS) posted the draft Medicare physician fee schedule (MPFS) complete with expanded use of telehealth for a number of services.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abiomed, Biotricity, Siemens Healthineers.
A number of entities have sounded off on the FDA’s discussion paper for artificial intelligence (AI), including several medical societies that would like to see autonomously operating algorithms subjected to more stringent review than supervised algorithms. Vibhor Rastogi, general partner at Symphony AI of Los Altos, Calif., told BioWorld that the company is on board with many of these concerns, adding that the FDA discussion paper does a “good job of balancing innovation and patient safety.”
HONG KONG – Singapore is Biofourmis Inc.’s latest destination for its Biovitals Sentinel platform to remotely monitor COVID-19 patients, with the country’s Ministry of Health (MOH) becoming the company’s latest customer.
Keeping you up to date on recent developments in neurology, including: Quanterix biomarker technology used to measure neuronal injury in COVID-19 patients; AI could speed up and improve Alzheimer's diagnosis; Mental fatigue of MS linked to inefficient recruitment of neural resources.
More than 70% of individuals using Big Health’s newest digital therapeutic, Daylight, achieved remission of generalized anxiety disorder (GAD) within 10 weeks, and the benefit persisted for at least six months, according to results published in Depression and Anxiety.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Arthrex, Image Processing Technologies, Smith & Nephew.
PARIS – Therapixel SA, of Nice, France, has obtained 510(k) clearance from the U.S. FDA for its Mammoscreen technology, a software platform based on artificial intelligence (AI) and used by radiologists for reading screening mammograms. “Obtaining FDA clearance is the result of working with radiologists over the past three years in order to develop a powerful tool providing relevant assistance in their day-to-day work,” Matthieu Leclerc-Chalvet, CEO of Therapixel, told BioWorld.
HONG KONG – Chugai Pharmaceutical Co. Ltd. is hoping to start phase I trials for an as-yet-unnamed digital solution for measuring pain levels in endometriosis patients that it is co-developing with Biofourmis Inc.
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