The company does not expect the warning letter to materially impact its manufacturing capacity, sales or ability to seek ...

The draft guidance addresses concerns that pulse oximeters are less accurate for people with dark skin tones. Experts raised ...

Interrupted access to health-related data has already led to worse outcomes and could undermine faith in the U.S. healthcare system, experts say.

Questioned by senators at a Thursday hearing, President Donald Trump's FDA nominee said he would reevaluate which scientific ...

Illumina is not banned from operating in the country and will continue to serve its existing customers, a company ...

Discure Technologies, a clinical-stage medical device company pioneering treatments for degenerative disc disease and other orthopedic disorders, today announced its acceptance into the U.S. Food and ...

Philips stopped selling its Tack endovascular system because of cases where additional interventions were needed to remove ...

President Donald Trump upped tariffs on China and said delayed tariffs on Mexico and Canada would take effect. Catch up on ...

The regulator said the buyout “would lead to a highly concentrated market for outsourced hydrophilic coatings and eliminate ...

Mickelsen, whose work led to the development of Boston Scientific’s fast-growing Farapulse device, is building a new PFA tool ...

The credit ratings agency is most concerned about Medicaid cuts and how government layoffs will affect device approvals.

The president also maintained that the pause on duties for Canada and Mexico will come to an end Tuesday.