FDA extends pandemic-era policy allowing certain device, production changes without prior approval

Companies can make limited modifications on certain devices and manufacturing processes to address supply shortages or production limitations.

By Ricky Zipp • Nov. 2, 2023

Drilling down on obesity drugs: What medtech executives are saying

Investor concerns that interest in GLP-1s will slow demand for medical devices and procedures have shaved roughly $370 billion in value from stocks across the medtech sector, according to research by Mizuho.

By Susan Kelly • Nov. 2, 2023

Explore the Trendline➔

Top 5 stories from MedTech Dive

From the top medtech trends to watch in 2026 to haphazard layoffs at the Food and Drug Administration and the evolving use of AI in the medtech sector, here is a collection of top stories from MedTech Dive.

By MedTech Dive staff

White House orders HHS to start collecting reports on the safety of AI in healthcare

President Joe Biden outlined the planned program as part of an executive order on “safe, secure, and trustworthy” artificial intelligence.

By Nick Paul Taylor • Nov. 1, 2023

Stryker’s Lisa Kloes talks cementless implants, robotics as future of knee business

The manager of Stryker’s knee business also discussed the growing role of ambulatory surgery centers in orthopedics.

By Elise Reuter • Updated Nov. 8, 2023

FDA warning letter accuses Wavi of selling unapproved neurological device

Wavi markets its headset as providing a baseline scan for patients who have a traumatic event, an injury or are worried about their brain as they age.

By Nick Paul Taylor • Nov. 1, 2023

GE HealthCare sales resilient despite ‘highly volatile’ economy

The company raised its earnings forecast for 2023 as it outlined plans to expand margins and navigate China's anti-corruption campaign.

By Elise Reuter • Oct. 31, 2023

11 key moments in Philips’ massive recall of respiratory devices

The recall of millions of sleep apnea devices and ventilators is still ongoing more than two years later, as Philips works to repair and replace affected machines.

By Elise Reuter • Oct. 31, 2023

Tracking Philips Respironics recalls

Philips recalled its Trilogy ventilators to fix new and previously reported problems with the machines. The company issued a mandatory software update and changed the devices’ instructions.

By Elise Reuter • Updated Oct. 3, 2024

FDA posts updated safety data on Bayer’s Essure, notes progress on improving study

The agency removed the “inadequate” progress tag it applied last year after Bayer acted to get people back in the study.

By Nick Paul Taylor • Oct. 31, 2023

4 medtech companies to watch this week in earnings

GE HealthCare and Stryker are among the top medtech companies posting financial results in the third week of this earnings season. 

By Susan Kelly • Oct. 30, 2023

Resmed cuts 5% of staff amid profitability push

The company has stopped some projects that were not working well as it seeks to cut operating costs, CEO Mick Farrell told investors. 

By Elise Reuter • Oct. 30, 2023

Philips leader signed off on sale of respiratory devices despite evidence of health risks: report

Roy Jakobs approved the sale of respiratory devices held by manufacturers after the company stopped shipping new machines, according to an article published last week by Pittsburgh Post-Gazette and ProPublica.

By Nick Paul Taylor • Oct. 30, 2023

Masimo prevails against Apple in USITC patent investigation

The patent dispute over pulse oximetry functions could result in a ban on imports of some Apple Watches.

By Susan Kelly • Oct. 27, 2023

Edwards posts early look at tricuspid device, stoking Abbott rivalry ahead of FDA panel

Nearly 94% of patients had their condition improve to mild or no tricuspid regurgitation six months after treatment, according to the study.

By Nick Paul Taylor • Oct. 27, 2023

Baxter’s Heather Knight talks combating sepsis — and how AI can help

The company’s group president for medical products and therapies says the right fluid management practices can help save lives and lower hospital costs.

By Susan Kelly • Oct. 27, 2023

GE HealthCare’s imaging AI will become ‘increasingly meaningful’ to growth: Moody’s

Even if modestly accretive, AI could support longer-term revenue targets at GE HealthCare and its competitors, Moody’s analysts wrote.

By Nick Paul Taylor • Oct. 27, 2023

Accuray lays off nearly 6% of radiotherapy workforce

The company delivered fourth quarter results that fell short of analyst expectations in August, causing its share price to fall.

By Nick Paul Taylor • Oct. 27, 2023

Boston Scientific looks to new devices in 2024 to drive growth

The company expects to receive FDA approval for its Agent drug-coated balloon and its Farapulse pulsed-field ablation system next year.

By Elise Reuter • Oct. 26, 2023

Abbott’s resorbable scaffold improves outcomes in below-the-knee artery disease, study finds

The device maker plans to submit the Esprit BTK data to the Food and Drug Administration for review.

By Nick Paul Taylor • Oct. 26, 2023

Boston Scientific study results support coronary drug-coated balloon in US

The results, shared at TCT 2023, found the company’s drug-coated balloon performed better than an uncoated balloon in procedures to reopen blocked arteries.

By Elise Reuter • Oct. 25, 2023

Edwards, Medtronic post low-risk TAVR data, allaying fears of market disruption

The late-breaking results, shared at TCT 2023, will have little impact on clinical practice or market share, J.P. Morgan and Stifel analysts predicted.

By Nick Paul Taylor • Oct. 25, 2023

Thermo Fisher cuts 2023 forecast, citing volatile economic conditions

Customer spending remains constrained overall, while economic conditions in China have weakened, CEO Marc Casper said on a Wednesday earnings call.

By Susan Kelly • Oct. 25, 2023

GE HealthCare, Novo Nordisk partner to use ultrasound to treat diabetes, obesity

The collaborators will study the use of peripheral focused ultrasound as a non-invasive, non-pharmacological method of managing blood glucose.

By Nick Paul Taylor • Oct. 25, 2023

Fresenius’ work to replace hemodialysis tubing flagged as Class I recall by FDA

Agency officials warned healthcare professionals last year about the potential for silicone tubing to expose patients to toxic compounds.

By Nick Paul Taylor • Oct. 25, 2023

5 takeaways from the FDA’s updated list of cleared AI/ML medical devices

The agency recently added 171 new devices to its list, with radiology once again accounting for the most authorizations.

By Elise Reuter • Oct. 24, 2023