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AI Detection System, Critical Limb Ischemia Device Gain FDA 'Breakthrough' Status

 
• By David Filmore

Two companies disclosed Breakthrough Device designations from US FDA on Jan. 29, one for an artificial intelligence tool for detecting intracranial hemorrhage, and the other for a system to treat critical limb ischemia.

[Editor's note: For a list of publicly disclosed breakthrough devices and status details, check out Medtech Insight'sUS Breakthrough Devices Tracker.]

US FDA has recently selected an artificial intelligence (AI) software tool to help detect intracranial hemorrhage and a novel catheter/stent...

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More from Regulation

MHRA’s Tallon Hails PMS Regulation As Start Of UK Device Framework Transformation

 
• By Ashley Yeo

16 June marked the first major new regulatory instrument in the UK’s post-Brexit transition to a standalone device regulatory system for Great Britain.

Increasing Safety Concerns Spur Scrutiny of Device Plastics Use

 
• By Elizabeth Orr

With new regulations limiting the use of plastics popping up worldwide, the medtech industry sees arguments on both sides. Some argue hasty bans of PFAS ("forever chemicals") would harm patients, while others say phthalates should be phased out to protect the public.

UK Healthtech Center Of Excellence Given Key MHRA Digital Regulation Role

 
• By Ashley Yeo

Ahead of the 11 June UK spending review and its anticipated funding uplift for healthcare and life sciences, the MHRA announced an expansion of its digital expertise by creating a dedicated hub in Leeds, a renowned center of medtech excellence.

Where Do Questions Surrounding The EU’s AI Act Leave The Medtech Industry?

 
• By Amanda Maxwell

The EU’s Artificial Intelligence Act, which entered into force on 1 August 2024, is already facing turbulence.

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