EU industry will be celebrating, albeit in lockdown, as the EU proposal for a one-year delay to the MDR has made it through the European Parliament and is on track to become law within the next month.
The European Parliament has backed the European Commission’s proposal (2020/0060 (COD)) to postpone the date of application of the EU Medical Devices Regulation (MDR) by one year to 26 May 2021.
There should now be enough time for the document to be signed off by the Council of the EU –...
The ceramic device, designed to reduce complications, will be exclusively distributed by Zimmer Biomet and initially available in 30 hospitals, with broader European access expected by 2026.
Amendments to Germany’s – barely in force – health reform law will be decided after the summer break. The new DRGs payments plan and service groups will be reviewed, but critics fear for the law’s future.
Combination products are no longer fringe – they are the “new normal,” consultant Stephen O’Rourke told Medtech Insight. The EU has the expertise to handle the regulatory complexity, but only if connects the dots between silos. That’s the challenge, he said, and the opportunity.
A government-backed program is working on improving the ability to run dementia clinical trials in the UK, and access to trials for participants.
Luna Health has raised $23.6m in Series A funding to support regulatory submissions, clinical studies and manufacturing for its insulin patch pump.
Combination products are no longer fringe – they are the “new normal,” consultant Stephen O’Rourke told Medtech Insight. The EU has the expertise to handle the regulatory complexity, but only if connects the dots between silos. That’s the challenge, he said, and the opportunity.
The US FDA has cleared NeuroOne's OneRF trigeminal nerve ablation system for the treatment of trigeminal neuralgia. This minimally invasive method utilizes radio frequency energy to alleviate pain, offering an alternative to traditional medications and surgeries. A fall commercial launch is planned.
