Attorneys said many questions remain about LDT regulation after the FDA lost its legal fight. A recent warning letter could ...

Coating for the guidewires could come off and get left in patients, which could result in extended or additional procedures.

Quest plans to refine, develop and validate the technology and is aiming to launch the test in North America next year.

The recall comes more than one year after Medtronic announced it would exit the ventilator market.

Kate Benedict joined Medtronic as president of the company’s acute care and monitoring business, the company announced Monday ...

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

Caris, which offers tools for disease diagnosis, therapy selection and treatment monitoring, is the latest company to test ...

The abrupt termination of the 17 panelists guiding the CDC’s vaccine recommendations could yield a new committee more aligned ...

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

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

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

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