To promote consistency and reliability in analytical chemistry studies for premarket submissions, the FDA shared recommended approaches for device biocompatibility analysis.

Older medical devices with unsupported software pose cybersecurity threats that regulators and industry are struggling to solve. Here are four steps experts say can help mitigate risks.

Stryker CEO Kevin Lobo said the company had a “very active deal pipeline” on an earnings call in July. The focus was on smaller acquisitions and fast-growing assets, Lobo said. The Nico buyout is the ...

Politan Capital Management said its candidates captured two board seats in Thursday’s shareholder vote, citing a preliminary analysis.

Koffey was elected to Masimo’s board in June 2023 along with Politan-backed candidate Michelle Brennan, a former Johnson & Johnson executive. The hedge fund argued that Masimo’s $1 billion acquisition ...

Some people are facing delays in filling prescriptions for the glucose sensor. Abbott expects to resolve the problem soon.

Meanwhile, Boston Scientific is still waiting for antitrust regulators to conclude their review of its proposal to buy Axonics, which was announced in January.

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.

The clearance adds a Centiloid scale tool to GE Healthcare’s Mim software to help clinicians determine the density of amyloid plaque.

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.

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 ...