Ross Segan was chosen to lead the office, which handles premarket authorizations and recalls, in the agency’s Center for Devices and Radiological Health.

Nico sells devices for navigating through the brain, visualizing the organ, removing tumors and clots and collecting tissue.

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.

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

Just 30 of 157 heart devices with Class I recalls underwent premarket clinical testing, according to a study published in the Annals of Internal Medicine.

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

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.

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 ...

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 ...

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.

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