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CMS Could Streamline Coverage For Breakthrough Medtech Under House Proposal

 
• By Sue Darcey

Newly introduced bill would seek to smooth the Medicare coverage and reimbursement pathway for breakthrough devices.

Newly proposed legislation in the US House could help innovative medtech products get market pick-up more quickly by permitting three years of transitional coverage by Medicare for products designated by FDA as “breakthrough devices."

The “Ensuring Patient Access To Critical Breakthrough Products Act,” H.R. 5997, introduced June 5 by Reps. Suzan Delbene, D-Washington,...

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Innovative Wants Injunction Against J&J Subsidiary After $442M Antitrust Verdict

 
• By Elizabeth Orr

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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.