Medtronic nets FDA nod for smart insulin pen app

The clearance paves the way for the launch of Medtronic’s Smart MDI system, which combines its InPen and Simplera continuous glucose monitor for people who take multiple daily insulin injections.

By Susan Kelly • Nov. 22, 2024

FDA plan would alert public sooner on high-risk device recalls

The Center for Devices and Radiological Health’s pilot program is meant to cut the time between the FDA’s awareness of potentially high-risk recalls and when the public is notified.

By Ricky Zipp • Nov. 22, 2024

Explore the Trendline➔

Medical device safety in spotlight after high profile recalls

From Philips’ massive recall of respiratory devices to ongoing health risks with breast implants, medical devices tied to patient harm have put a focus on product safety.

By MedTech Dive staff

Healthcare industry braces for RFK Jr.

Kennedy's views on vaccines in particular are causing alarm among some physicians and investors.

By Susanna Vogel • Nov. 22, 2024

Philips revises ventilator directions after airflow issue tied to 4 injuries

Aerosol deposits could accumulate on a sensor and affect oxygen delivery, the FDA said in a recall notice. Several of the ventilator models were previously recalled for separate problems.

By Susan Kelly • Nov. 21, 2024

FDA warns providers on Getinge devices tied to 17 serious injuries

Getinge recalled endoscopic vessel harvesting devices after receiving 18 complaints in four months. The FDA added the devices to its shortages list following the recall.

By Nick Paul Taylor • Nov. 18, 2024

Trump nominates RFK Jr. to lead HHS

The nomination of a prominent vaccine skeptic to the head of the nation’s largest healthcare program is expected to alarm some public health experts.

By Sydney Halleman • Nov. 14, 2024

FDA breakthrough device decisions rebound after recent declines

The FDA designated 166 products under its breakthrough devices program in its most recent financial year, reversing the downward trend seen as the COVID-19 pandemic eased.

By Nick Paul Taylor • Nov. 14, 2024

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.

By Nick Paul Taylor • Nov. 14, 2024

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.

By Ricky Zipp • Nov. 11, 2024

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.

By Rebecca Pifer • Nov. 11, 2024

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.

By Susan Kelly • Nov. 11, 2024

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.

By Susan Kelly • Nov. 7, 2024

With Trump victorious, biotech industry’s focus turns to his plans for FDA, FTC

The president-elect has said he’ll let Robert F. Kennedy Jr. “go wild” on healthcare, while many expect a leadership change at the FTC could lower M&A scrutiny.

By Ned Pagliarulo , Ben Fidler • Nov. 7, 2024

Advamed asks CMS to cover extra imaging of dense breast tissue

Many patients with dense breast tissue currently have to pay out of pocket or forgo potentially life-saving additional testing, Advamed said in a letter.

By Nick Paul Taylor • Nov. 6, 2024

Medtronic settles pulse oximetry lawsuit alleging inaccuracies

Roots Community Health has sued 12 other firms, including GE Healthcare, CVS and Walgreens, and called for manufacturers and the FDA to ensure the devices work for everyone.

By Elise Reuter • Nov. 4, 2024

FDA clears iRhythm’s second 510(k) in response to warning letter

However, the company said it will delay a submission for its next-generation Zio cardiac monitoring system until remediation efforts are further along.

By Susan Kelly • Nov. 1, 2024

Michelle Tarver faces challenges as new CDRH leader. But patient groups, industry are optimistic.

Patient advocates are hoping for change under new director Michelle Tarver, while industry groups look to build on former director Jeff Shuren’s leadership.

By Elise Reuter • Oct. 31, 2024

AI could be a game changer, but healthcare needs to be ‘exceedingly careful’

Artificial intelligence tools could help solve workforce challenges. Implementation, however, can be difficult, pushing organizations to consider less risky administrative and back-office tasks first.

By Emily Olsen • Oct. 29, 2024

FDA advises clinicians to stop using Hologic radiographic markers

Hologic has recalled the Biozorb devices after 188 reports of adverse events in patients who received the implants in breast tissue.

By Susan Kelly • Oct. 28, 2024

Medtronic wins FDA approval for Affera mapping and ablation system

Affera combines mapping technology with a catheter capable of performing radiofrequency and pulsed field ablation.

By Nick Paul Taylor • Oct. 25, 2024

Medtech Conference recap: New CDRH leader details approach; AI and LDTs in focus

Catch up on our recent coverage of Advamed’s The Medtech Conference.

By Elise Reuter • Oct. 23, 2024

iRhythm’s Zio AT design changes win FDA clearance

The agency cleared one of two 510(k) submissions iRhythm filed for the heart monitor after receiving a warning letter from the agency last year.

By Susan Kelly • Oct. 23, 2024

Tarver named new director of FDA’s device center

Michelle Tarver, who will officially replace longtime CDRH leader Jeff Shuren, emphasized the agency’s focus on patients in comments last week.

By Elise Reuter • Oct. 22, 2024

That’s a wrap: 5 takeaways from The Medtech Conference

The conference — Advamed’s largest — featured an appearance by the device center’s new acting director and sessions on AI, clinical trial diversity and the FDA’s contentious LDT rule.

By Elise Reuter • Oct. 22, 2024

5 steps to navigate the FDA’s new lab developed test rule

Laboratories face a series of upcoming deadlines to comply with stricter FDA oversight of in-house tests. Here are five strategies labs can take to be ready.

By Susan Kelly • Oct. 21, 2024