Calgary-based healthtech startup RetinaLogik has closed $1.1 million CAD in convertible note financing and secured a Class II ...

These include a Category 2 Medical Device License from the Food and Drug Administration (FDA) of Thailand; Class B licenses from the FDA of the Philippines and the Department of Medical Equipment ...

For those with Class IIa or above AI-related devices, compliance with the EU’s AI Act is likely to be akin to the EU MDR.

EM2AI has received a Category 2 Medical Device Licence from the Food and Drug Administration (FDA) of Thailand; a Class B Medical Device Licence from the Food and Drug Administration (FDA) of the ...

Globus Medical's financial advisor is Morgan Stanley & Co. LLC and Wyrick Robbins Yates & Ponton LLP is serving as legal ...

Globus Medical (NYSE:GMED) announced today that it agreed to acquire chronic pain treatment developer Nevro (NYSE:NVRO).

European Medicines Agency (EMA), in close collaboration with the European Commission, has established a standard procedure ...

Obesity-drug maker Metsera Inc.'s stock jumped 47% on Friday as the biggest gainer among three initial public offerings bucking a swoon in the equity market to rise in their stock-market debuts Friday ...

Steps 1 and 2 ... for devices with AI-enabled device software functions. This guidance fits within FDA’s Total Product Life Cycle (“TPLC”) approach to reviewing and monitoring medical ...

ColdVentures enters exclusive distribution partnership with Medco Sports Medicine: Los Angeles Monday, January 27, 2025, 16:00 Hrs [IST] ColdVentures, a leading medical device com ...

Medical devices that use ML, in part or in whole ... This document provides guidance to manufacturers who are submitting a new or amendment application for Class II, III and IV MLMD under the ...