Class IIb medical devices: Medium-high risk level According to the EU Medical Device Regulation (MDR), Class IIb includes products with a medium to high risk. Typical examples are ventilators ...

The Wearable Medical Devices Market is expected to witness a healthy double-digit growth rate by 2028 ... often known as wearable medical devices, are a class of sophisticated electronic devices ...

On April 7, 2025, the U.S. Food and Drug Administration (“FDA” or “the agency”), classified Q’Apel Medical, Inc.’s (“Q’Apel” or “the company”) voluntary recall of 1,617 units ...

The Central Drugs Standard Control Organisation (CDSCO) has upgraded its online registration system and has asked all medical device manufacturers to re-submit market standing certificates and non ...

Augurex Life Sciences Corp., a leader in autoimmune biomarker-based diagnostics, today announced that Health Canada has approved SPINEstat™, a first-in-class diagnostic blood test for axial ...

manufactures Class I and II medical devices and sells disposable medical devices. The company operates with a modest gross profit margin of 25% and currently maintains a market capitalization of $ ...

Q'Apel has submitted three Medical Device Reportable events for the Hippo product to date; these adverse events include a reported tip detachment, retrieved without patient injury; a vessel rupture; ...

Despite the Trump administration's recent 90-day pause on reciprocal tariffs, hospitals and health systems remain concerned about the ongoing impact of tariffs on medical devices. Industry ...

SPINEstat™, a novel, first-in-class diagnostic blood test for axial spondyloarthritis (axSpA), has been approved by Health Canada. This approval marks an important milestone in addressing a ...

is a supplier of medical devices that develops and manufactures Class I and II medical devices and sells Class I and II disposable medical devices through operating subsidiaries in China.