Businesses should reevaluate the classification of their clinical decision software based on a new FDA guidance, Kyle Faget of Foley & Lardner LLP tells Medtech Insight.
Clinical decision software (CDS) manufacturers may be “upset” due to necessary re-evaluation from the Food and Drug Administration’s final draft guidance on CDS, says Foley and Lardner partner Kyle Faget.
Faget, co-chair of the firm’s healthcare and life science practice groups, spoke to MedTech Insight about the new guidance and...
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.
