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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.
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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.
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QuidelOrtho to lay off employees after firing CEO
Interim CEO Michael Iskra said in a recent presentation to investors the diagnostics firm plans to lay off less than 10% of its staff.
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EPA final rule limits EtO emissions for medical device sterilizers
Medtech companies now have two years to come into compliance with the new regulations.
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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.
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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.
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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.
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FDA seeks feedback on expansion of premarket cybersecurity guidance
The agency is providing information on cybersecurity requirements for companies seeking authorization of new devices.
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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.
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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.
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3M names William Brown CEO
Michael Roman, who has led 3M since 2018, will step down on May 1.
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3M’s board approves health spinoff
Investors will receive one share of Solventum for every four shares of 3M they hold on March 18.
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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.”
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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.
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Deep Dive
Why Cigna is capping cost increases for pricey GLP-1 weight loss drugs
The first-of-its-kind move comes as pharmacy benefit managers continue to try to prove their value to clients, and shows how major players are shoring up to meet sky-high GLP-1 demand.
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Q&A
AI 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.
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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.
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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.
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Siemens Healthineers launches anatomy hologram app on Apple Vision Pro
The prototype app has potential uses in patient communication, medical education and surgical planning.
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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.
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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.
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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.
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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.
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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.
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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.