Medical Devices: Page 45
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IOS/Zuma Press/Newscom
TrackerTracking 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 -
Sean Gallup via Getty Images
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 -
Explore the Trendline➔
Sara Silbiger via Getty Images
TrendlineTop 5 stories from MedTech Dive
From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.
By MedTech Dive staff -
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 -
Courtesy of ResMed
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 -
Permission granted by Philips
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 -
Eric Thayer via Getty Images
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 -
Courtesy of Edwards Lifesciences
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 -
Permission granted by Baxter International
Q&ABaxter’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 -
zirconicusso via Getty Images
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 -
pcess609 via Getty Images
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 -
Courtesy of Boston Scientific
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 -
Courtesy of Abbott
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 -
Permission granted by Boston Scientific
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 -
magicmine via Getty Images
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 -
peakSTOCK via Getty Images
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 -
saengsuriya13 via Getty Images
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 -
Courtesy of GE Healthcare
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 -
Permission granted by Johnson & Johnson
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 -
Sara Silbiger via Getty Images
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 -
Permission granted by Medtronic
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 -
Courtesy of Insulet Corp.
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 -
Patrik Stollarz / Staff via Getty Images
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 -
VCG / Stringer via Getty Images
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 -
DSCimage for iStock via Getty Images
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
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