GE Healthcare’s head-only MRI scanner cleared by the FDA

The system is designed to shorten scan times, which may be better for people who struggle to stay still or have claustrophobia, and to detect more subtle abnormalities.

23andMe to lay off more than 200 employees amid business struggles

The genetic testing firm will also close its therapeutics arm. CEO Anne Wojcicki said the cuts are necessary to “focus on the long-term success of our core consumer business.”

Dean Kamen, insulin pump pioneer, wants to shake up diabetes tech

Kamen and Sequel Med Tech CEO Alan Lotvin say they are offering greater precision in insulin delivery with new pump technology in the Twiist device.

Updated Nov. 25, 2024

Livanova hits sleep apnea trial goals, plans FDA filing

Leerink analysts said the results were largely in line with outcomes in a trial of Inspire Medical’s rival device but cautioned that Livanova may have a hard time breaking into the sleep apnea market.

J&J’s Ottava surgical robot to begin clinical trial after FDA nod

With FDA approval of an investigational device exemption, J&J’s soft tissue robot moves a step closer to challenging Intuitive Surgical’s da Vinci system.

Boston Scientific resumes PFA trial in new patient group after pausing enrollment

Boston Scientific expects to complete enrollment in the coming months in the study comparing pulsed field ablation to anti-arrhythmic drugs in patients with persistent AFib, a spokesperson said.

GE Healthcare inks AI mammography pact with Radnet

The alliance positions GE Healthcare to distribute Radnet software designed to help mammography centers view images, prioritize cases and support other steps in the workflow.

Advamed CEO congratulates Trump, stresses need for public policy support

Donald Trump’s election victory comes weeks after the FDA named a new leader for the medical device center and as the agency’s contentious LDT final rule is challenged in court.

Baxter to restart second IV fluid production line at hurricane-damaged site

CFO Joel Grade told investors Friday that Baxter expects an approximately $200 million hit to sales in the fourth quarter from Hurricane Helene's disruption.

How the healthcare industry is reacting to a second Trump term

Donald Trump’s first term as president was characterized by significant turbulence for government healthcare programs. Here’s how some of the most influential industry groups responded to the Republican’s reelection.

Tandem, Insulet tout Type 2 expectations as tech attracts new users

Insulet saw strong insulin pump adoption among new users with Type 2 diabetes following its recent FDA clearance, while Tandem plans to file a Type 2 submission by year’s end.

Exact Sciences’ forecast cut shocks analysts

The lowered sales forecast, which analysts called a “shocking guidance update,” contributed to a 23% drop in the cancer screening company’s stock on Wednesday.

J&J wins FDA approval for Varipulse PFA system

J&J is the third medtech company to gain U.S. approval for pulsed field ablation, a new atrial fibrillation treatment seeing rapid adoption.