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 ...

Vivek Jain, CEO of parent ICU Medical, recently told investors the company has faced more challenges than expected when it bought the Smiths medical device business in 2022.

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 ...

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

In response to the escalating cyber threats and changing regulatory requirements facing the medical device industry, Marcus ...

The European Commission lacked oversight authority to examine the proposed sale of a cancer-detection company to biotech company Illumina, the court found.

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

About 43% of all AI-enabled devices cleared or approved by the FDA through 2022 were missing validation data, and only 28% were tested prospectively, according to a Nature Medicine study.

AI was the most compelling new technology for the fourth year in a row, with leaders also saying the technology had shown the most improvement, according to the Center for Connected Medicine.

An Edwards spokesperson said the layoffs, affecting 3% of its workforce, are a “one-time right-sizing” deemed necessary after assessing resources amid the sale of the critical care business to BD.

The European Society of Cardiology said the treatment may be considered for certain patients with uncontrolled, drug-resistant high blood pressure but outlined lingering concerns.

Priced at $49 for one 14-day sensor, or $89 per month, Abbott’s offering is competitive with Dexcom’s Stelo sensor.