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More Cancer Cases Tied To Breast Implants, FDA Says

 
• By Elizabeth Orr

The US agency announced this week that it’s reviewing multiple reports of a form of carcinoma that arises in the scar tissue around a breast implant.

Doctor holding a silicone breast implant and a pink ribbon.
• Source: Shutterstock

More people with breast implants have been diagnosed with a rare cancer, the US Food and Drug Administration said on 8 March.

The agency’s announcement focuses on squamous cell carcinoma (SCC), which forms in the capsule of scar tissue around breast...

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More from Regulation

FDA Regulations ‘Lock Out’ Clinically Proven Neuromodulation Devices

 
• By Natasha Barrow

Flow Neuroscience's neuromodulation headset for the treatment of depression is approved and marketed in the EU. However, two years on, the company is still waiting for US FDA approval despite being assigned breakthrough device designation.

EU Publishes Guidance On Interplay Between AI Act And Medtech Regulations

 
• By Amanda Maxwell

Overlapping clinical testing requirements and decision-making around significant changes to MDAI are among the tricky subjects that the new document explains.

UK MHRA Joins New Global Network For Safe Use Of AI In Healthcare

 
• By Natasha Barrow

The UK's regulatory agency is the first to join a new international network for oversight of AI in healthcare run by a non-profit organization, HealthAI, the global agency for responsible AI in health.

MHRA Opens Second AI Airlock Program For Applications

 
• By Natasha Barrow

"The AI Airlock program creates a supervised testing ground where novel technologies and challenge areas can be safely investigated," said James Pound, MHRA interim executive director of innovation and compliance.

More from Policy & Regulation

UK MHRA Joins New Global Network For Safe Use Of AI In Healthcare

 
• By Natasha Barrow

The UK's regulatory agency is the first to join a new international network for oversight of AI in healthcare run by a non-profit organization, HealthAI, the global agency for responsible AI in health.

Volta Files For US FDA Approval Of Next-Gen Cardio Mapping Software After Winning Labeling Expansion

 
• By Marion Webb

Volta Medical received a labeling expansion for its AF-Xplorer mapping software to treat A-fib, which provides the clinical evidence needed to broaden US access. The company hopes for FDA clearance for its improved second-gen AF-Xplorer II software.

£2Bn Industrial Strategy Boost For UK Life Sciences Growth Sector

 
• By Ashley Yeo

The Modern Industrial Strategy is the first of this summer’s UK blueprints for supporting life sciences industrial activity and transforming NHS healthcare delivery. The UK market must also benefit from its own innovation activity, says industry.