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MHRA's AI as medical device pilot opens for applicants

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has put out a call for developers of artificial intelligence as a medical device (AIaMD) technology to join its new regul

News

Vanda slams FDA rejection of gastroparesis drug

The FDA has declined to approve Vanda Pharma's tradipitant for delayed gastric emptying (gastroparesis), prompting a furious response from the company.

News

Neuralink gets breakthrough tag for sight-restoring implant

Elon Musk's Neuralink has been awarded breakthrough status from the FDA for an implantable chip – dubbed Blindsight – that promises to restore the sight of people with vision impairment.

Digital

The booming medical device sector: How well are suppliers ad...

Reviewing new international research, Peter Muller and Mike Baird of Schlafender Hase explore how Class 2 and 3 device manufacturers in Europe and the US are coping with rising Agency contr

Market Access

Balancing innovation and safety: The impact of Medtech regul...

The Medtech sector is currently at a crossroads, facing a potential choice between rapid technological advancement and strict regulatory oversight.

News

Advanz wins stay on EU revocation of Ocaliva license

There's been another twist to the tale of Advanz Pharma's efforts to keep its primary biliary cholangitis (PBC) therapy Ocaliva on the market in the EU.

MHRA's AI as medical device pilot opens for applicants

Vanda slams FDA rejection of gastroparesis drug

Neuralink gets breakthrough tag for sight-restoring implant

The booming medical device sector: How well are suppliers ad...

Balancing innovation and safety: The impact of Medtech regul...

Advanz wins stay on EU revocation of Ocaliva license

Gene therapy firm Kate Tx snapped up by Novartis for $1.1bn

Coming soon: The Life Sciences Industry Report 2025 – insigh...

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