The comment period for a draft guidance document on labeling for LASIK surgery equipment has been extended for another month. Ninety people have already filed comments, representing a wide range of views about the procedure.
The US Food and Drug Administration recently extended the comment period on a controversial draft guidance document that would recommend stronger patient safety guidelines for Laser-Assisted In-Situ Keratomileusis (LASIK) surgery, but plenty of stakeholders from all sides of the issue have already had their say.
LASIK surgery uses a laser to reshape the cornea to change the way the eye focuses, and can treat people...
Children with biliary atresia (BA) exhibited neurodevelopmental deficits and increased autism traits, with earlier surgery linked to better general neurodevelopment.
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.
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.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Nearly 80 documents have been posted on the tracker since its last update.
So far, calls for much needed changes to the medtech regulatory system have focused on the Medical Device Regulation. Don’t neglect the IVD Regulation, industry says.
This week, two device testing labs in China landed FDA warning letters; refunds for 1Health.io clients; FDA AR/VR product list expands.
This week, a Delaware court awarded Auris Health shareholders $1bn in a lawsuit against Johnson & Johnson; Abbott recalled some FreeStyle Libre 3 sensors; and McKesson purchased a controlling interest in a Florida cancer care chain.
