Capstan Medical, a startup focused on robotic-assisted mitral and tricuspid valve replacement, recently completed its first ...

ECRI included other medtech-related threats on its list of patient safety concerns, noting that cybersecurity breaches can ...

Kelly, who made several key hires at the CDRH and helped negotiate the last user fee agreement, announced his departure in a ...

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The draft guidance addresses concerns that pulse oximeters are less accurate for people with dark skin tones.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

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 ...

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 significant head-to-head competition.” ...

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 ...