Regulatory & Quality

A federal court in Utah has entered an injunction halting the sale of various silver products promoted as COVID-19 treatments.

How will products liability law be applied to AI?

The agency warned healthcare providers on Tuesday that serological tests intended to detect antibodies to SARS-CoV-2 should not be used as the sole basis to diagnose infection. FDA said it does not expect an antibody test can be shown to...

Medical device companies are moving forward as the pandemic continues--but what challenges are they facing?

Consider the trade-offs of using 3D printing to address current supply demands of personal protective equipment.

Some industry experts say that the rapid shift toward telemedicine in response to COVID-19 safety recommendations will stick long after the pandemic is over.

There's no blueprint for how medical device field service teams conduct business during times like this, but an expert from ServiceMax shares insight and strategies for medical device companies to ensure the health and safety of their workforce...

Boston Scientific is recalling 6,130 Imager II 5F Angiographic Catheters because there is a potential for the catheter tip to become detached during a patient procedure or during procedure preparation. FDA had received nine injury reports for this...