BD receives FDA warning letter over quality system violations

Inspectors found 111 open tickets for software defects categorized as catastrophic or severe patient harm. Several safety complaints were also listed that BD didn’t report within the required timeframe.

Heart valve developer Anteris launches IPO

IPOs in medtech have been sparse, but some analysts said improving market conditions could support a revival of offerings in 2025.

CMS proposes Medicare coverage for transcatheter tricuspid replacement

Edwards submitted a request for a national coverage determination in February, after receiving FDA approval for its Evoque device earlier that month.

Updated Dec. 23, 2024

Boston Scientific updates cryoablation catheter instructions after 4 death reports

The update followed a higher than expected number of reports of esophageal injury after catheter ablation procedures for atrial fibrillation.

‘Research that’s desperately needed’: White House conference spotlights women’s health

“Sometimes the most under-hyped sectors are the best places to build very large businesses,” said one venture investor who attended the Dec. 11 event.

Merit Medical president to resign after unspecified conduct allegations

Joseph Wright’s resignation is effective in January, and CEO and founder Fred Lampropoulos has been reappointed president.

Dexcom adds generative AI to over-the-counter CGMs

Dexcom this week began rolling out the feature, which analyzes data to provide personalized tips and recommendations.

Namandjé Bumpus, FDA’s No. 2 official, to depart agency at end of year

Bumpus replaced agency veteran Janet Woodcock as principal deputy commissioner in February 2024. She was previously the FDA’s chief scientist.

BD to pay $175M to settle charges of misleading investors on Alaris pump

BD will pay a civil penalty to resolve charges it misled investors about risks associated with sales of its Alaris infusion pump, the Securities and Exchange Commission said.

Boston Scientific recalls Accolade pacemakers tied to 2 deaths

Certain Accolade pacemakers can permanently enter safety mode, which limits the devices’ ability to treat patients properly and requires early replacement.

CDRH cyber official on compliance with new rules, ongoing security threats

Nastassia Tamari discussed compliance with new device cybersecurity requirements, the risks of legacy devices and frequent cyberattacks in healthcare.

Updated Dec. 17, 2024

PFA to surpass radiofrequency ablation in 2025: Citi survey

Pulsed field ablation could soon be used in the majority of electrophysiology procedures to treat atrial fibrillation as Medtronic, Boston Scientific and Johnson & Johnson battle for market share.

Zimmer receives FDA nod for stemless shoulder implant

The Osseofit devices are intended to match patients’ shoulder bone anatomy and preserve healthy bone in total shoulder replacement procedures.

Augmedics names Paul Ziegler as CEO

Augmedics sells an augmented reality headset that allows spine surgeons to view virtual images of the patient’s bones and surgical instruments inside the body. Ziegler is the former CEO of Viewray.

FDA issues first early alert with Fresenius Kabi infusion pump recall

Fresenius Kabi is asking hospitals to remove certain pumps because of the risk of an alarm that could interrupt treatment.

Endoquest robotic system gets FDA OK to launch clinical trial

A pivotal study of the robotic platform in colorectal surgery will begin at five hospitals in early 2025.

4 takeaways from the FDA’s first digital health advisory committee

Industry and patient representatives debated how the FDA should regulate generative AI in medical devices and address new challenges with the technology, such as the use of complex models that can change quickly.

Capstan Medical raises $110M for heart valve with robotic system

The startup’s third round of financing includes support from Intuitive Surgical’s venture capital arm.

Labcorp closes takeover of Ballad Health outreach laboratory services

Labcorp continued its streak of hospital lab purchases with a deal that will expand its testing capabilities to communities in Tennessee, Virginia, North Carolina and Kentucky.

Patterson, a dental products distributor, agrees to $4.1B sale to healthcare investor

Last week, Patterson Companies announced it would seek strategic alternatives after the company’s profit decreased by one-third in its fiscal second quarter.

Masimo lays off 75 employees in California

Under new leadership, the patient monitoring company is allocating resources to fewer projects as it focuses on market opportunities that address unmet needs, a spokesperson said.

Artivion says cybersecurity incident has disrupted order, shipping processes

The heart device manufacturer has taken certain systems offline in response to the incident, which involved the acquisition and encryption of files.

How Trump’s second term will affect the medtech industry

From M&A and tariffs to new health leaders, here are the top issues for the medtech industry to watch when President-elect Donald Trump returns to office.