The FDA posted a second Smiths recall on Wednesday related to a problem with certain ParaPac ventilator kits. A knob that sets the tidal volume, or the amount of air delivered with each breath, can ...

Bausch + Lomb is assessing interest from potential buyers as a way around the roadblock, the FT wrote. The company had a market cap of $6.27 billion on Monday.

Exact’s test could compete with Guardant Health’s Shield blood test, which received approval from the Food and Drug Administration in July.

Powerful Medical, a leading innovator in AI-powered cardiology solutions, is proud to announce the appointment of Dr. Timothy ...

The launch will create competition for the wave of companies that entered the OTC hearing aid market when the FDA changed its regulations in 2022. Sony and the Bose-partnered Lexie began selling ...

Authored by industry experts Pia Windelov, Vice President of Life Sciences Strategy and Product Marketing at Lionbridge, and Camilla de Villiers, Managing Director of Life Sciences at Lionbridge, the ...

Silk Road Medical said in a securities filing that the antitrust waiting period expired Thursday evening, opening the door to complete the $1.26 billion deal.

The FDA said the problems “raise concerns about the quality and integrity of data generated by the labs,” which provide third-party testing and validation data services for device firms.

J&J did not provide Auris Health with resources to achieve regulatory milestones after acquiring the robotics company in 2019, the judge found.

The Series B round will support commercial expansion and product additions for Spectrawave’s system used in the treatment of coronary artery disease.

A survey found 48% of labs will discontinue LDTs if they do not qualify for an exception under the FDA final rule.

Inflammatix has now raised over $200 million in private capital, in addition to more than $50 million in grants and contracts.