FDA posts early alert about safety risk of Medline’s fluid delivery sets

The agency issued the alert as part of a pilot to improve the timeliness of communications about actions it believes are likely to be high-risk recalls. 

By Nick Paul Taylor • Jan. 6, 2025

Shift left today: Electronics procurement visibility for reliable device development

Periods of uncertainty test the resolve of even the most well-oiled medical device supply chains.

Jan. 6, 2025

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Medical device industry continues to turn to AI

While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.

By MedTech Dive staff

Olympus begins CEO search after Kaufmann resignation

Stefan Kaufmann, former CEO of Tokyo-based Olympus, stepped down in October after the company investigated an allegation that the executive purchased illegal drugs.

By Susan Kelly • Jan. 3, 2025

FDA closes 2024 with string of early alerts on device safety risks

Olympus advised providers to stop using an endoscope accessory due to an infection risk linked to 120 injuries and one death.

By Susan Kelly • Jan. 3, 2025

FDA-commissioned review finds no safety concerns linked to tampons

Officials commissioned the independent review in September in response to a study that found tampons may expose users to metals.

By Nick Paul Taylor • Jan. 3, 2025

Abbott, Dexcom settle glucose monitor patent lawsuits

The rival companies agreed not to sue each other for the next 10 years.

By Elise Reuter • Jan. 2, 2025

Few medical devices are designed for children. An FDA-Children’s National collaboration aims to change that.

Kolaleh Eskandanian, chief innovation officer at Children’s National Hospital, said the partnership is meant to address the many challenges with developing devices for children and infants.

By Elise Reuter • Jan. 2, 2025

Top 10 medtech deals of 2024

Multibillion-dollar buyouts returned last year, led by Johnson & Johnson’s $13.1 billion acquisition of Shockwave Medical.

By Nick Paul Taylor • Jan. 2, 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.

By Elise Reuter • Updated Dec. 23, 2024

Robots, AI and PFA: The top medtech Q&As of 2024

From challenging market leaders to the growing influence of artificial intelligence, medical device executives had a lot to discuss this year. Check out MedTech Dive’s top Q&As of 2024.

By Ricky Zipp • Dec. 20, 2024

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.

By Susan Kelly • Dec. 20, 2024

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.

By Nick Paul Taylor • Dec. 20, 2024

Medical device recalls under the spotlight in 2024

Medtech regulators and watchdogs took a closer look at recalls in 2024. Here’s a recap of notable recalls and product safety actions in the past year.

By Elise Reuter • Dec. 19, 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.

By Nick Paul Taylor • Dec. 19, 2024

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.

By Susan Kelly • Dec. 18, 2024

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.

By Elise Reuter • Dec. 18, 2024

Trump’s return to office brings uncertainty for medtech industry

With about one month before inauguration day, check out a roundup of MedTech Dive’s coverage on what President-elect Donald Trump’s new administration means for medical device companies.

By Ricky Zipp • Dec. 18, 2024

Medtech firms have cut thousands of jobs this year. Will layoffs continue in 2025?

Industry experts said profit pressures and M&A contributed to job cuts. They said layoffs will likely continue into next year, but some expect the cuts to slow.

By Elise Reuter • Dec. 18, 2024

Boston Scientific pacemaker recall tied to 832 injuries, 2 deaths

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

By Ricky Zipp • Updated Feb. 25, 2025

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.

By Elise Reuter • Dec. 17, 2024

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.

By Elise Reuter • Dec. 16, 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.

By Susan Kelly • Dec. 16, 2024

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.

By Elise Reuter • Dec. 13, 2024

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.

By Nick Paul Taylor • Dec. 13, 2024

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.

By Susan Kelly • Dec. 13, 2024