Medical Devices: Page 6
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Courtesy of Abbott
Abbott recalls Heartmate LVAD communication system
The FDA said eight reported injuries have been linked to the problem, which can cause the mechanical heart pump to unexpectedly stop or start.
By Susan Kelly • March 12, 2024 -
3M names William Brown CEO
Michael Roman, who has led 3M since 2018, will step down on May 1.
By Ricky Zipp • March 12, 2024 -
Trendline
The EU Medical Device Regulation
While the European Union’s MDR went into effect in May 2021, device makers still face a range of uncertainties and potential problems with continued extensions and outstanding questions still in play.
By MedTech Dive staff -
Stock via Getty Images
FDA panel backs Lumicell’s agent for breast cancer imaging tool
One panelist who voted yes said the “incremental benefits outweigh the small risks of anaphylaxis.”
By Nick Paul Taylor • March 11, 2024 -
magicmine via Getty Images
Advamed report finds racial disparities in care, proposes fixes
The report found White patients were more likely to receive several cardiovascular procedures than Black patients, which limits access to medical technology.
By Nick Paul Taylor • March 11, 2024 -
Courtesy of Medtronic
Medtronic recalls more than 45,000 catheter tubing units after injury reports
The issue, which is linked to 26 injuries, could result in neurological harm or death, FDA said.
By Nick Paul Taylor • March 8, 2024 -
Rick Loomis via Getty Images
Former Stimwave CEO found guilty of selling fake implantable device component
The former executive was convicted on two counts for her role in creating and marketing the faulty devices.
By Susan Kelly • March 8, 2024 -
your_photo via Getty Images
Q&AAI oversight is top challenge facing global device regulators: FDA official
Melissa Torres, CDRH’s associate director of international affairs, spoke about the importance of the International Medical Device Regulators Forum and how countries are struggling with AI oversight.
By Ricky Zipp • March 8, 2024 -
Michael M. Santiago / Staff via Getty Images
Siemens Healthineers launches anatomy hologram app on Apple Vision Pro
The prototype app has potential uses in patient communication, medical education and surgical planning.
By Nick Paul Taylor • March 8, 2024 -
Courtesy of Dexcom
Dexcom’s over-the-counter nod sets stage for broader CGM use
The FDA’s decision allows people who don’t take insulin, including those who don’t have diabetes, to use the devices without a prescription.
By Elise Reuter • March 7, 2024 -
Courtesy of Roche
Roche to take on Abbott, Dexcom with its first CGM
The new sensor is designed to last for 14 days but requires finger-stick calibration.
By Nick Paul Taylor • March 7, 2024 -
Tim Boyle via Getty Images
Baxter to close Massachusetts site, lay off 59 people
News of the cuts comes 13 months after the company outlined plans to eliminate 3,000 positions.
By Nick Paul Taylor • March 7, 2024 -
Permission granted by Vicarious Surgical
Vicarious presses forward with soft tissue robot despite struggles
The company detailed upcoming milestones for its robotic surgery system on a fourth-quarter earnings call.
By Susan Kelly • March 6, 2024 -
Sarah Silbiger via Getty Images
Smiths Medical recalls nearly 86,000 syringe pumps over software problem
The company fixed the issues, which are linked to one reported injury, by updating its software.
By Nick Paul Taylor • March 6, 2024 -
Courtesy of Dexcom, Nick Jonas Super Bowl kit
Dexcom receives FDA clearance for first OTC glucose sensor
The diabetes tech firm is tailoring its software to the 25 million people in the U.S. who have Type 2 diabetes and do not use insulin.
By Nick Paul Taylor • March 6, 2024 -
Permission granted by Attune Medical
Haemonetics to buy Attune Medical for $160M
Attune’s device to help cool the esophagus during radiofrequency ablation procedures is a key piece of the acquisition.
By Susan Kelly • March 5, 2024 -
Permission granted by Becton Dickinson
BD starts trial of vascular covered stent in peripheral arterial disease
Peripheral vascular disease is one of six key platforms BD is targeting for growth.
By Nick Paul Taylor • March 5, 2024 -
Courtesy of Medtronic
Medtronic estimates up to 40 job losses in Ireland due to restructuring
The company confirmed the potential job reductions from shutting down its ventilator product lines in an email to MedTech Dive.
By Ricky Zipp • March 5, 2024 -
Courtesy of Dexcom
Dexcom, Novo Nordisk call for FDA input on digital diabetes detection devices
The companies want clarity on what evidence would be needed for new technologies to detect undiagnosed Type 2 diabetes or prediabetes.
By Nick Paul Taylor • March 4, 2024 -
Tim Boyle via Getty Images
Baxter considers selling kidney care unit to private equity
The company expects to divest its largest segment, whether through a spinoff or a sale, in the second half of the year.
By Elise Reuter • March 4, 2024 -
Sarah Silbiger via Getty Images
GE Healthcare recalls incubators due to risk of newborns falling
The Food and Drug Administration labeled the recall as a Class I event after a serious injury was reported.
By Nick Paul Taylor • March 4, 2024 -
Permission granted by Boston Scientific
Boston Scientific gains FDA nod for drug-coated coronary balloon
BTIG analyst Marie Thibault said physicians could rapidly adopt the first-of-its-kind device.
By Susan Kelly • March 1, 2024 -
Permission granted by Abbott
Q&AAbbott leader on the ‘hype’ and ‘reality’ of pulsed field ablation
Christopher Piorkowski, chief medical officer for the electrophysiology business, talks about the high expectations for the new atrial fibrillation treatment.
By Susan Kelly • March 1, 2024 -
juankphoto via Getty Images
FDA responds to claim breast implant removal is ‘reasonable’ to cut cancer risk
Experts convened by the American Association of Plastic Surgeons concluded it may be “considered reasonable” to remove textured breast implants to reduce the risk of a rare cancer.
By Nick Paul Taylor • Updated March 4, 2024 -
Courtesy of Medtronic
Medtronic asks ITC to stop sales, imports of Axonics devices
The complaint is the latest move in a long-running patent fight between the two companies regarding neuromodulation devices.
By Nick Paul Taylor • March 1, 2024 -
Courtesy of Insulet Corp.
Insulet sizes up competition as Tandem, Medtronic plan new insulin patch-pumps
Insulet CEO Jim Hollingshead said the company is “very confident” in its competitive position as rivals develop their own patch pumps.
By Elise Reuter • Feb. 29, 2024
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