Medical Devices: Page 35
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Courtesy of Fresenius
Fresenius Kabi receives FDA warning letter over issues at ex-Ivenix site
Inspectors found fault with the handling of corrective and preventive actions for the Ivenix Infusion System.
By Nick Paul Taylor • March 15, 2024 -
Permission granted by Medtronic
Q&AMedtronic’s Sean Salmon on cardiovascular competition, carving out new markets
The president of Medtronic’s cardiovascular portfolio talked about renal denervation, a new procedure to reduce blood pressure and rising competition in cardiac ablation.
By Elise Reuter • March 15, 2024 -
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 -
Getty Images via Getty Images
Better Therapeutics lays off staff, considers winding down business
The digital therapeutics developer received authorization for a Type 2 diabetes treatment app last year but has struggled for money.
By Nick Paul Taylor • March 15, 2024 -
Kevin Dietsch via Getty Images
EPA final rule limits EtO emissions for medical device sterilizers
Medtech companies now have two years to come into compliance with the new regulations.
By Elise Reuter • March 14, 2024 -
Johnny Greig via Getty Images
US hospitals predict uptick in procedures as staffing pressures ease
The forecast and a small overall rise in budgets could benefit Boston Scientific, Medtronic and Stryker, BTIG analysts said.
By Nick Paul Taylor • March 14, 2024 -
Retrieved from Exactech on March 14, 2024
Exactech hit with warning letter over implant packaging
The FDA found faults in the orthopedics company’s analysis of complaints demonstrating defective packaging could have accelerated wear to its implants.
By Elise Reuter • March 14, 2024 -
nopparit via Getty Images
Mass General Brigham works with FDA to create brain-computer interface group
The collaborators aim to resolve the clinical, regulatory, coverage and payment questions facing developers of the devices.
By Nick Paul Taylor • March 13, 2024 -
zhuweiyi49 via Getty Images
AI to expand medtech portfolios, revenue streams: Moody’s
The rating agency predicts AI will start to have a positive impact on medical device companies in the next two years.
By Nick Paul Taylor • March 12, 2024 -
Justin Sullivan via Getty Images
3M’s board approves health spinoff
Investors will receive one share of Solventum for every four shares of 3M they hold on March 18.
By Nick Paul Taylor • March 12, 2024 -
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 -
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
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