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.
Sudden cardiac arrest (SCA) kills millions of people worldwide each year, triggered by an electrical malfunction in the heart that causes it to unexpectedly stop beating, often without warning. Health care startup Transformative AI Ltd. wants to reduce those deaths. To that end, the company has secured $1.7 million in seed funding for artificial intelligence (AI)-driven software that predicts a patient’s risk of suffering SCA based on subtle physiological changes.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Color, Labcorp, Rapid Medical, Stratus Medical, Zebra Medical.
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