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

The companies scrapped the merger because securing FTC clearance “proved unviable in terms of time, expense and opportunity.” ...

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

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

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

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

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

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

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

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

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

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