Medical Devices: Page 39
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Courtesy of Sequel Med Tech
Deka’s automated insulin delivery system, powered by patient-led app, gets FDA clearance
Sequel Med Tech will sell the new system, which integrates with Tidepool’s Loop insulin dosing algorithm.
By Nick Paul Taylor • March 20, 2024 -
Sara Silbiger via Getty Images
FDA stops two manufacturers from importing plastic syringes
The agency issued import alerts to Jiangsu Caina Medical and Jiangsu Shenli Medical Production because their products didn’t meet quality requirements or were different from FDA-authorized versions.
By Nick Paul Taylor • Updated April 8, 2024 -
Explore the Trendline➔
Permission granted by Boston Scientific
TrendlineNew medical devices are reshaping the medtech industry
From pulsed field ablation devices to glucose sensors and surgical robotics, new medical technologies are transforming patient care and how people manage their health.
By MedTech Dive staff -
Retrieved from Titan on September 12, 2022
Titan Medical to merge with imaging firm Conavi, ending strategic review
The combined company will focus on selling Conavi’s cardiovascular imaging system used in minimally invasive procedures.
By Elise Reuter • March 19, 2024 -
Justin Sullivan / Staff via Getty Images
J&J Medtech, Nvidia partner to bring AI to the operating room
The companies see the collaboration as a way to help facilitate the fast, secure deployment of AI algorithms for surgical decision-making.
By Nick Paul Taylor • March 18, 2024 -
N/A via Getty Images
Deep Dive6 ways the FDA can improve medical device recalls
Experts said improving how adverse events are tracked and requiring manufacturers to use electronic notifications could make devices safer.
By Elise Reuter • March 18, 2024 -
Courtesy of Intuitive Surgical
Intuitive details launch plan for new da Vinci 5 robot
The fifth generation of the company’s flagship robotic surgery system will be introduced in a phased launch.
By Susan Kelly • March 18, 2024 -
Courtesy of Intuitive Surgical
Intuitive lands FDA clearance for new da Vinci robot
The soft tissue robotics leader incorporated new features into the system, from tissue sensing feedback to a smaller size and more comfortable console.
By Susan Kelly • March 15, 2024 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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
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