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

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.

There are only 5 medical devices classified as Class II devices by the TFDA. They are breast enhancement products, physical therapy products, alcohol detectors, and HIV test kits for research and ...

This is largely due to the expanding medical device market in India as a result of increased health awareness, a growing middle class, and government health initiatives.

The classification of medical devices are done at the state and central level based on the risk profile of the devices. For instance, the manufacturing of class A and B devices, which have lower ...

Medical devices are revolutionizing healthcare. These devices improve patient outcomes, from tracking and recording vitals to measuring glucose levels to supporting cardiac conditions. The future ...

Eyebright Medical Technology has announced that its phakic intraocular lens (IOL), the Loong Crystal PR, has received Class III Medical Devices Certificate from the National Medical Products ...

The update comes about six weeks after an early alert flagged reports of 120 injuries and one death linked to reprocessing of the device. CEO Scott Whitaker said “an exemption was provided for most ...

Rajiv Nath, Forum Coordinator for the Association of Indian Medical Device Industry (AiMED), said, “Indian manufacturers compete more effectively in tier II and tier III cities, where supply ...