Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 30 documents have been posted on the tracker since its last update.
Thirty-three guidance documents on medical devices and diagnostics issued by regulatory authorities from around the world were added to Medtech Insight’s Guidance Tracker in the past month.
The updated tracker includes an updated guideline by the EU Medical Device Coordination Group, which clarifies...
The US FDA has authorized around 107 devices with Predetermined Change Control Plans in place, with PathAI's AISight Dx digital pathology image management system one of the latest. Medtech Insight talks to Eric Walk, chief medical officer, to find out about the process and its benefits.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.
A panel of regulatory pros offered stakeholders tips for avoiding FDA citations after facility inspections. The July 29 webinar, hosted by ProPharma and Hyman Phelps and McNamara, follows the agency’s May announcement that it plans to up random foreign inspections.
The US FDA has updated its guidance document on small business eligibility determinations for medical device firms. Industry observers urge companies to ask for the status early to avoid any potential hold-ups.
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.
