FDA

Opternative, a Chicago-based purveyor of online and mobile refractive eye exams, received a warning letter from the FDA last fall.

A recently released analysis report from the Deloitte Center for Government Insights that examines the US’s current and proposed software as a medical device (SaMD) regulatory landscape, and includes suggestions on how the FDA’s pre-certification pilot program and other initiatives could better serve this fast-moving industry.

Medtronic has finally received FDA clearance for Guardian Connect, its smartphone-connected standalone CGM for patients who use multiple daily injections (MDI) for their insulin.

Palo Alto, California-based Cognoa’s machine learning app for pediatric behavioral health has received categorization from the FDA as a diagnostic medical device for autism, according to an announcement from the company.

Roche’s Accu-Chek Connect Diabetes Management App has hit yet another snag with the FDA.

Food and Drug Administration Commissioner Dr.

The FDA announced yesterday that it will permit marketing of Viz.

Yesterday the Clinical Decision Support (CDS) Coalition released a comment broadly criticizing the FDA’s recent CDS draft guidance, noting that the draft would expand the scope of FDA regulations, and that it fails to take a risk-based approach, lumping in many low-risk programs already on the market.

Empatica's Embrace, the consumer-facing wearable for epileptic seizure detection, received 510(k) clearance from the FDA last month.

The road to FDA clearance for medical devices may change radically in the next year.