A published thought leader and peer reviewer, Hiremath envisions a future where AI, smart implants, and digital health ...

Medical Device Companies should be aware of a recent en banc ruling by the Court of Appeals for the Ninth Circuit that has the potential to increase litigation involving class III medical devices.

NICE reviewed various technologies and recommended DERM as the only AI tool suitable for NHS use. It is the first dermatology ...

Teleflex (NYSE: TFX) announced that it received FDA 510(k) clearance for expanded indications of its QuikClot Control+ ...

Certain devices considered not to have undergone full review – such as, for example, Class IIb (non-well established technology) implantable and Class III medical devices approved via a route ...

RICHMOND, Texas, April 10, 2025 /PRNewswire/ -- Velentium, a leading engineering and manufacturing firm specializing in the design and development of Class II and Class III medical devices, is ...

and Class III devices have the least regulation. Class I devices are named “License” medical devices because they require full registration with the TFDA prior to sale or manufacturing.

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 ...