Gaeta’s last role was a brief stint at Shockwave, which named her CFO two months before accepting J&J’s $13.1 billion ...

The startup received de novo authorization for the AI tool, the first of its kind that analyzes mammogram images to predict ...

The latest fundraise included investors ARK Invest, Founders Fund, G42, Lightspeed, Sequoia Capital and others. Neuralink ...

Joseph Wolk told an investor conference that the company’s tariff estimate is a “moving target” as trade talks continue with ...

Freenome plans to complete all modules of its premarket approval submission in mid-2025.

Smiths has not reported any serious injuries or deaths related to the issues, but the FDA sees a risk of harm.

The Trump Administration has effectively ended the Biden Administration's attempt to regulate lab-developed tests,” TD Cowen ...

Nvidia, which is already working with J&J and Medtronic, plans to partner with medtech companies to build platforms for ...

IPO drought, the industry is questioning whether the window for medtech public offerings is open following a small burst of ...

The company also shared more details of its exit from the TAVR market and the impact of FDA layoffs on product review times.

Boston Scientific said it would halt worldwide sales of its Acurate devices due to “increased clinical and regulatory ...

The Court of International Trade said the president overstepped his authority, halting various duties. After an appeal, the ...