FDA
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Sarah Silbiger via Getty Images
Medtech industry calls for FDA staffing transparency in MDUFA talks
Stakeholders also discussed changing international user fees and the FDA’s spending trigger for the program.
By Elise Reuter • March 5, 2026 -
Alamy
Abbott wins FDA approval for updated heart failure monitoring device
The company redesigned the reader to fit in a carry-on suitcase and be easier to use day to day.
By Nick Paul Taylor • March 2, 2026 -
Explore the Trendline➔
Courtesy of Intuitive Surgical
TrendlineTop 5 stories from MedTech Dive
From the top medtech trends to watch in 2026 to haphazard layoffs at the Food and Drug Administration and the evolving use of AI in the medtech sector, here is a collection of top stories from MedTech Dive.
By MedTech Dive staff -
Courtesy of Beta Bionics
FDA warns Beta Bionics on unreported complaints, insulin pump changes
The Food and Drug Administration warning letter detailed unreported low blood sugar and a software change to correct for delayed glucose readings.
By Elise Reuter • Feb. 26, 2026 -
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FDA posts early alert for safety issue with Impella heart pump devices
The cassettes have an increased risk of purge leaks that can lead to the loss of hemodynamic support.
By Nick Paul Taylor • Feb. 26, 2026 -
Mario Guti via Getty Images
Medline addresses bed fire risk linked to death
The FDA said hand pendants and cords may overheat, causing the devices to spark, burn, melt, smoke and catch fire.
By Nick Paul Taylor • Feb. 18, 2026 -
Anna Moneymaker via Getty Images
HHS elevates officials into Kennedy’s inner circle in advance of midterms
The HHS secretary has four new senior advisors to help him “move faster and go further” on his Make America Healthy Again agenda. The appointments preempt the GOP’s midterm messaging push.
By Rebecca Pifer Parduhn • Feb. 13, 2026 -
Sarah Silbiger via Getty Images
Novocure wins FDA approval to treat pancreatic cancer with electric fields
Winning approval to target the 15,000 U.S. patients with locally advanced pancreatic cancer is the first step in a broader expansion in the tumor type.
By Nick Paul Taylor • Feb. 13, 2026 -
Sarah Silbiger via Getty Images
FDA breakthrough program starts FY2026 at steady pace
Orthopedics was the most active area over the second half of 2025, with the FDA issuing 13 breakthrough designations to devices in the therapeutic area.
By Nick Paul Taylor • Feb. 9, 2026 -
Courtesy of Johnson & Johnson
J&J recalls coil systems used in aneurysm treatment
Healthcare providers are advised to stop using the devices after a failure to detach was linked with four serious injuries and one death.
By Susan Kelly • Feb. 6, 2026 -
Courtesy of Medtronic
Medtronic wins expanded FDA label for 780G insulin pump
The 510(k) decision clears the device for use with ultra-rapid-acting insulins from Eli Lilly and Novo Nordisk.
By Nick Paul Taylor • Feb. 5, 2026 -
Courtesy of Abiomed
J&J corrects Impella heart pumps over issue linked to 22 serious injuries
The urgent correction notice is the latest in a series of actions related to the safety of Impella devices.
By Nick Paul Taylor • Feb. 4, 2026 -
Courtesy of Beta Bionics
Beta Bionics receives FDA warning letter
The letter, which the FDA has not yet published, does not affect Beta Bionics’ ability to market, manufacture or distribute products, the company said.
By Elise Reuter • Feb. 2, 2026 -
Courtesy of Grail
Grail files for FDA approval of multi-cancer early detection test
Premarket approval could help the company secure coverage from commercial payers and Medicare.
By Nick Paul Taylor • Feb. 2, 2026 -
Courtesy of Boston Scientific
Top medtech trends to watch in 2026
From M&A to surgical robotics and user fee negotiations, the medical device industry has a busy year ahead. Check out MedTech Dive’s roundup of the top medtech trends to watch in 2026.
By Ricky Zipp • Jan. 29, 2026 -
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CDRH on track for review timelines despite staff cuts
The Center for Devices and Radiological Health said it is on track to meet review times specified by user fee agreements, despite “resource challenges.”
By Elise Reuter • Jan. 29, 2026 -
Courtesy of Ōura
FDA guidance eases wearables oversight. But experts have questions about what’s next.
Experts say two new guidances — issued without the usual public comment period — leave questions about how patients will navigate a growing pool of wearables.
By Elise Reuter • Jan. 27, 2026 -
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Integra recalls wound and burn devices amid reports of serious injuries
Packaging failures could lead to breaches in the sterile barrier and patient infections.
By Nick Paul Taylor • Jan. 23, 2026 -
Elise Reuter/MedTech Dive, data from MedTech Dive
AdvaMed leaders on tariffs, MDUFA and wearables
AdvaMed CEO Scott Whitaker and Mick Farrell, new board chair of the trade group, weighed in on important issues for the medtech industry one year into the Trump administration.
By Elise Reuter • Jan. 22, 2026 -
Courtesy of Boston Scientific
Boston Scientific recalls stent over issue linked to 3 deaths
The company said the deaths were associated with off-label or investigational use of the device.
By Nick Paul Taylor • Jan. 20, 2026 -
Elise Reuter/MedTech Dive
Deep Dive5 topics to watch as MDUFA negotiations restart
The next Medical Device User Fee Amendments, which will set how much the FDA can raise from the industry in fees over a five-year period, are expected to go to Congress this year.
By Elise Reuter • Jan. 14, 2026 -
Courtesy of Whoop
FDA exempts more wearable, AI features from oversight
In a pair of guidance documents released Tuesday, the regulator clarified the types of wellness features and clinical decision support tools that don’t fall under medical device oversight.
By Elise Reuter • Jan. 8, 2026 -
Courtesy of Medtronic
Deep Dive4 medtech topics to watch in 2026
From insurance coverage questions to M&A and tariffs, here are the top storylines to watch in the medical device space in 2026.
By Ricky Zipp • Jan. 8, 2026 -
Permission granted by Stereotaxis
Stereotaxis wins FDA approval for robotically navigated ablation catheter
Stereotaxis’ CEO said the company has been “hampered clinically, commercially and strategically” by its prior dependence on a J&J catheter.
By Nick Paul Taylor • Jan. 7, 2026 -
Courtesy of Edwards Lifesciences
Edwards receives FDA approval for mitral valve replacement system
The Sapien M3 device is the first approved mitral regurgitation treatment to use a transseptal approach, Edwards said.
By Elise Reuter • Dec. 23, 2025 -
Sarah Silbiger via Getty Images
FDA posts Class I recall notice about Medtronic heart vent catheters
The company received three complaints about patients who had perforation injuries linked to the devices.
By Nick Paul Taylor • Dec. 23, 2025
