The company has asked users to monitor patients frequently to ensure the appropriate infusion is being delivered.

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

The move comes after a recent investigation found Chinese government procurement practices discriminate against EU companies ...

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

Most of the 10,000 HHS employees let go this spring could qualify for the class, according to lawyers. It’s the latest in a ...

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

On Friday, the HHS fleshed out a preliminary budget released in the spring and gave new details about which of its programs ...

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

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

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

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