The pieces in JAMA Cardiology consider the merits of FDA's "515 Program Initiative" to classify preamendment devices and its application to a minimally invasive ventricular assist device.
Is FDA’s "515 Program Initiative
" for preamendment devices leading to approvals of high-risk devices based on flawed evidence? This question is addressed by two...
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"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.
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.
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.
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.
EU countermeasures against US tariffs suggest medtech categories exported to the EU could be targeted for tariffs. MedTech Europe and the German IVDs industry have stressed the negative effects this would have on patient care.
Innovative Healthcare is asking for a permanent injunction against Johnson & Johnson subsidiary Biosense Webster after winning a $442 million antitrust verdict. The injunction aims to prevent continued anticompetitive practices in the electrophysiology catheter market.
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.
