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

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

The draft guidance addresses concerns that pulse oximeters are less accurate for people with dark skin tones.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

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

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

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

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

Enlil, Inc., a Shifamed portfolio company accelerating innovation for regulated product companies with its comprehensive ...

Farrell replaces Tom Frinzi on the heels of a challenging year for the eye implant maker marked by a demand slowdown in China, its largest market.

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

Mexico, Canada and China all announced they would counter the president's orders after additional duties went into effect this week.

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