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

Explore the Trendline➔

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

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

J&J MedTech Chairman Ashley McEvoy to step down

McEvoy is leaving the company after 27 years to pursue other opportunities. Tim Schmid will now lead the MedTech business.

By Elise Reuter • Updated Oct. 24, 2023

Olympus recall of abdominal insufflation devices linked to reports of 10 serious injuries, 1 death: FDA

The Food and Drug Administration labeled the recall a Class I event.

By Ricky Zipp • Updated Oct. 30, 2023

Medtronic gains FDA approval for extravascular defibrillator

The device to treat abnormal heart rhythms is designed to avoid risks associated with traditional implantable cardioverter defibrillators that have leads running through the veins to the heart.

By Susan Kelly • Oct. 23, 2023

Insulet receives FDA clearance for Omnipod 5 iPhone app

The application removes the need for patients with iPhones to carry a separate controller to manage bolus dosing.

By Elise Reuter • Oct. 23, 2023

Philips’ orders fall in Q3, overshadowing sales growth and return to sleep apnea market

CEO Roy Jakobs said during a third-quarter earnings call that there is still “significant demand” for the company’s sleep apnea products.

By Nick Paul Taylor • Oct. 23, 2023

Intuitive’s Q3 sales miss estimates as robot leasing, China demand weigh

The robotic surgery leader’s overall procedure growth, however, exceeded market expectations.

By Susan Kelly • Oct. 20, 2023

AdvaMed CEO warns Congress of supply shortages from EtO, PFAS regulations

The trade group leader called for changes to the EPA’s proposals, while a scientist with UCSF said lawmakers should turn to science free of vested financial interests. 

By Elise Reuter • Oct. 20, 2023

Physicians forecast Edwards’ 5-year data will have limited impact on low-risk TAVR market

Some doctors think TAVR may perform numerically worse but see little impact on the market unless there is a statistically significant result.

By Nick Paul Taylor • Oct. 20, 2023