Merit predicts the portfolio, which includes devices used in procedures to remove or replace heart rhythm device leads, will add $40 million a year to its sales.

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

The patient can use his implant to turn on lights, make video calls, play music and shows, read books and buy products online without using his hands or voice.

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.

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

Roche will roll out its Accu-Chek Smartguide in the Netherlands, Switzerland and Germany. The company hopes to stand out from competitors with features to predict hypoglycemia.

With the rise of interest around AI since the release of large language models (LLMs), there is pressure on MedTech executives to get ahead of industry peers regarding AI, not only within devices but ...

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 ...

The addition of hearing aid capabilities has two parts: First, Apple is adding a pure-tone audiometry test that uses the earbuds and an iPhone or iPad to allow users to check their hearing in five ...

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.