FDA
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FDA seeks feedback on monitoring real-world performance of AI devices
The agency is looking for ways to detect, assess and mitigate changes to the performance of AI-enabled devices over time.
By Nick Paul Taylor • Oct. 1, 2025 -
Alex Wong / Staff via Getty Images
HHS plans to furlough more than 40% of staff if government shuts down
Under the contingency plan, the CMS would lose 47% of its staff, while the CDC and the NIH would lose 64% and 75%, respectively.
By Rebecca Pifer • Sept. 30, 2025 -
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 -
Stock via Getty Images
FDA expands early alert program to cover all medical devices
After a successful pilot, the agency has lifted the limitations on when it will provide early information about potentially high-risk safety events.
By Nick Paul Taylor • Sept. 30, 2025 -
gchutka via Getty Images
EssilorLuxottica wins FDA OK for myopia-slowing eyeglass lenses
Investigators saw a 71% reduction in myopia progression in children who used the lenses for two years.
By Nick Paul Taylor • Sept. 29, 2025 -
Courtesy of Biolinq
Biolinq gets FDA de novo nod for intradermal glucose sensor
The device, called Biolinq Shine, is indicated for people with Type 2 diabetes who don’t depend on insulin.
By Elise Reuter • Updated Sept. 29, 2025 -
Courtesy of HeartFlow
Heartflow receives FDA clearance for updated plaque analysis platform
The updated algorithm shows a 21% improvement in plaque detection, compared to the original version.
By Nick Paul Taylor • Sept. 25, 2025 -
Courtesy of Abiomed
J&J’s Abiomed starts third heart pump controller recall since June
As of Aug. 27, the company had reported five serious injuries and no deaths associated with the issue.
By Nick Paul Taylor • Sept. 24, 2025 -
Alamy
Medtronic wins FDA approval for urinary incontinence device
Analysts said Altaviva is an attractive option compared to rival products, informing their belief that Medtronic can capitalize on a large market opportunity.
By Nick Paul Taylor • Sept. 22, 2025 -
Alamy
FDA posts early alert about Abbott’s Tactiflex Ablation Catheter
Catheter tips came off three damaged devices during surgery but none of the patients suffered serious injuries or died.
By Nick Paul Taylor • Updated Sept. 22, 2025 -
Sarah Silbiger via Getty Images
FDA warns on unauthorized blood pressure, infant monitoring devices
Many of these devices currently sold over-the-counter do not have marketing authorization, the agency said in a notice.
By Elise Reuter • Updated Sept. 18, 2025 -
Permission granted by Becton Dickinson
BD expands Class I recall to cover 15 more Alaris pump infusion sets
BD, which has not received any complaints related to the issue, previously discontinued the devices affected by the expanded recall.
By Nick Paul Taylor • Sept. 17, 2025 -
hapabapa via Getty Images
Patients call for more medical device user fee funding, FDA staffing
Commenters to the FDA also advocated for safety reforms and for industry funds to be used for post-market monitoring.
By Elise Reuter • Sept. 11, 2025 -
Sarah Silbiger via Getty Images
Microbot receives 510(k) clearance for endovascular robot
The company will now complete final commercial activities in preparation for targeting the 2.5 million peripheral vascular procedures performed in the U.S. each year.
By Nick Paul Taylor • Sept. 9, 2025 -
Andrew Harnik via Getty Images
At Senate hearing, lawmakers express dissatisfaction with RFK Jr.’s vaccine moves
Robert F. Kennedy Jr. faced criticism Thursday even from Republican lawmakers over changes to federal vaccine policy as well as a leadership crisis at the CDC.
By Delilah Alvarado , Jonathan Gardner • Sept. 4, 2025 -
Kayla Bartkowsk via Getty Images
Over 1,000 HHS employees call for RFK Jr. to step down
The letter cites turmoil at the CDC, which is reeling from the firing of Director Susan Monarez and the departure of at least four high-level leaders last week.
By Rebecca Pifer • Sept. 4, 2025 -
Courtesy of Kardium
Kardium receives FDA OK for pulsed field ablation system
The company raised $250 million in July to expand its manufacturing capabilities and establish multiple teams to support the launch.
By Nick Paul Taylor • Sept. 4, 2025 -
Permission granted by Medtronic
Medtronic advances Abbott partnership with FDA nod
The company received FDA authorization to pair its 780G insulin pump with a glucose sensor made by Abbott, and to use the device for Type 2 diabetes.
By Elise Reuter • Sept. 2, 2025 -
Courtesy of Abiomed
J&J removes some Abiomed heart pump controllers from market
Abiomed reported one death associated with a pump driver circuit assembly that does not meet current specifications. The recall affects 69 controllers, a J&J spokesperson said.
By Susan Kelly • Aug. 28, 2025 -
Sarah Silbiger via Getty Images
Deep Dive4 medtech topics to watch for the rest of 2025
From M&A to MDUFA and the developing market in renal denervation, MedTech Dive covers the key issues to watch in the final months of the year.
By Ricky Zipp , Susan Kelly , Elise Reuter • Aug. 25, 2025 -
Courtesy of Boston Scientific
Boston Scientific recalls carotid stents over manufacturing defect
The FDA said the defect could injure blood vessels, damage the stent or release debris that could travel to the brain and cause a stroke.
By Nick Paul Taylor • Aug. 25, 2025 -
Sarah Silbiger via Getty Images
More than 1,100 devices have received the FDA’s breakthrough designation
The FDA updated its list of breakthrough devices as medtech groups lobby for faster Medicare coverage of products with the designation.
By Elise Reuter • Aug. 21, 2025 -
Permission granted by Aktiia
Q&AHow Aktiia built the first over-the-counter cuffless blood pressure monitor
Aktiia received FDA clearance in July for the first cuffless blood pressure monitor authorized to be sold over the counter.
By Elise Reuter • Aug. 20, 2025 -
Permission granted by NeuroOne
NeuroOne gains FDA clearance for trigeminal nerve ablation
The minimally invasive system uses radiofrequency energy to target nerve tissue causing facial pain.
By Susan Kelly • Aug. 20, 2025 -
Alamy
Medtronic recall of heart vent catheters tied to 3 serious injuries
The FDA said the request to quarantine the devices followed reports of the products “resisting shape retention when being bent.”
By Nick Paul Taylor • Aug. 19, 2025 -
Courtesy of Boston Scientific
Boston Scientific updates instructions of devices linked to 17 deaths
The update covers devices used in procedures to implant the company’s Watchman heart device.
By Nick Paul Taylor • Aug. 8, 2025
