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The draft guidance addresses concerns that pulse oximeters are less accurate for people with dark skin tones.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

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

Boston Scientific looks to catch up with Medtronic and Recor Medical in the much-hyped renal denervation space with its ...

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

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 ...

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

Thermo Fisher Scientific agreed to pay about $4.1 billion in cash to acquire Solventum’s purification and filtration business ...

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

Staar’s job cuts come “amid ongoing macroeconomic and geopolitical challenges that have pressured the business,” a ...