Healio

FDA releases final rule on classification, reclassification of medical devices

Please provide your email address to receive an email when new articles are posted on . The FDA issued a final rule that implements modifications made by the FDA Safety and Innovation Act, as well as ...
Nasdaq

Wright Medical Group N.V. Announces Update to Medicare Transitional Device Pass-Through Payment for AUGMENT® Regenerative Solutions

AMSTERDAM, The Netherlands, July 20, 2020 (GLOBE NEWSWIRE) -- Wright Medical Group N.V. (NASDAQ: WMGI) today announced that the Centers for Medicare & Medicaid Services (CMS) published an update to ...
The Financial Express

Approvals for medical devices may ease with new classification

Experts said that there's a need to constantly update the list so that its purpose doesn't get defeated. (Image/Freepik) The Central Drugs Standard Control Organisation’s (CDSCO’s) draft rules for ...
health.economictimes.indiatimes

CDSCO issues Cardio, Neuro devices revised classification draft; Seeks industry comments by month-end

New Delhi: The nodal licensing and regulatory body for medical devices, CDSCO, has issued the draft list of revised risk-based classification of devices in the cardiovascular and neurological domains ...
Health Service Journal

Getting classification right: Why remote monitoring safety depends on using the right level of medical device assurance

“Classification isn’t an administrative detail; it’s the foundation of patient safety,” he says. “If a platform is being used to support clinical decision-making, issue alerts or guide escalation, ...