CEO Dev Kurdikar said the decision may “come as a surprise” as Embecta just received FDA clearance for a patch pump, but the company “did not intend to do a full market launch of this product.” ...

The device is established in Europe, where the company said it has a 60% market share, but will be the first product of its type available in the U.S.

Intera makes a pump and a chemotherapy drug to treat liver tumors. Boston Scientific sees the purchase as a way to provide ...

High-stakes industries like aerospace and MedTech face similar challenges with outdated workflows. Streamlined, cloud-based ...

contextflow’s AI-driven technology enables radiologists to track lung nodules over time, assess malignancy, and generate high ...

A prolific medical research and author, Martin Makary criticized the FDA and CDC for their decision-making during the ...

The clearance paves the way for the launch of Medtronic’s Smart MDI system, which combines its InPen and Simplera continuous ...

The Center for Devices and Radiological Health’s pilot program is meant to cut the time between the FDA’s awareness of ...

Kennedy Jr. to lead the HHS caused a stir last week, with some politicians and industry groups applauding Kennedy’s ...

Powerful Medical has made history as the first company to win both the Best Science Startup and Overall Winner titles at the ...

Aerosol deposits could accumulate on a sensor and affect oxygen delivery, the FDA said in a recall notice. Several of the ...

CEO Vicky Demas joined Identifeye Health, a startup building an AI-supported retinal imaging device, after stints with Google ...