FDA

  • Food And Drug Administration Headquarters In Maryland
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    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 • Sept. 17, 2025
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    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 • Sept. 17, 2025
  • Boston Scientific's Farapulse pulsed field ablation device. Explore the Trendline➔
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    Trendline

    New 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
  • A sign for the FDA is shown in front of the headquarters building in Silver Spring, Maryland.
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    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 • Sept. 11, 2025
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    Sarah Silbiger via Getty Images
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    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 • Sept. 9, 2025
  • A person in a blue sit sits behind a desk at a hearing.
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    Andrew Harnik via Getty Images
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    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
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    Kayla Bartkowsk via Getty Images
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    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
  • Kardium's Globe mapping and ablation catheter for pulsed field ablation is shown.
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    Courtesy of Kardium
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    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 • Sept. 4, 2025
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    Permission granted by Medtronic
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    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 • Sept. 2, 2025
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    Courtesy of Abiomed
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    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 • Aug. 28, 2025
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    Sarah Silbiger via Getty Images
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    Deep Dive

    4 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 , , • Aug. 25, 2025
  • A view of Boston Scientific's corporate headquarters in Marlborough, Massachusetts, with a clear blue sky in the background.
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    Courtesy of Boston Scientific
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    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 • Aug. 25, 2025
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    Sarah Silbiger via Getty Images
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    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 • Aug. 21, 2025
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    Q&A

    How 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 • Aug. 20, 2025
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    NeuroOne gains FDA clearance for trigeminal nerve ablation

    The minimally invasive system uses radiofrequency energy to target nerve tissue causing facial pain.

    By • Aug. 20, 2025
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    Alamy
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    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 • Aug. 19, 2025
  • A closeup of Boston Scientific's Watchman FLX device is shown against a white background.
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    Courtesy of Boston Scientific
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    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 • Aug. 8, 2025
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    Alamy
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    Boston Scientific tells users about defibrillator problem linked to deaths, injuries

    A company spokesperson said in a statement to MedTech Dive that direct causation between the deaths and calcification of the leads cannot be assumed or confirmed.

    By • Aug. 7, 2025
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    Elise Reuter/MedTech Dive
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    Medical device industry says future MDUFA hikes unsustainable

    Device lobbyists’ priorities contrasted with patient advocates, who sought an increase in user fees and more funds for postmarket safety.

    By • Aug. 5, 2025
  • Monogram Technologies' robotic surgery system is displayed against a gray background.
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    News roundup

    Monogram robot marks autonomy milestone; Stereotaxis catheter cleared

    Monogram Technologies conducted its first fully autonomous robotic knee replacement surgery, while Stereotaxis won FDA clearance for a robotically navigated electrophysiology mapping catheter.

    By • July 31, 2025
  • A sign for the FDA is shown in front of the headquarters building in Silver Spring, Maryland.
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    hapabapa via Getty Images
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    Cardiosense wins FDA clearance for wearable heart monitor

    The device captures various types of heart data that could be used in AI models for cardiovascular parameters with the aim of lowering barriers to monitoring.

    By • July 31, 2025
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    Alamy
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    Edwards recalls arterial cannulas over exposed wires

    Exposed wires could puncture the artery and cause bleeding, inadequate perfusion and hemolysis, the FDA said in its Class I recall notice.

    By • July 25, 2025
  • A view of Baxter International's production facility in the state of North-Rhine Wetsphalia on January 15, 2021 in Halle, Germany.
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    Sascha Schuermann via Getty Images
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    Baxter recalls certain Novum pumps over issues tied to 79 injuries, 2 deaths

    The company has advised users to change the pump and infusion set at a time when a delay in treatment would not harm the patient.

    By • July 23, 2025
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    Courtesy of Whoop
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    Whoop’s FDA warning letter sparks debate over blood pressure as a wellness metric

    Whoop pushed back on the warning letter, claiming its blood pressure feature for a wearable wristband is for “wellness” and should not be regulated as a medical device.

    By • July 18, 2025
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    Sarah Silbiger via Getty Images
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    Integra recalls cranial drills over defect linked to 10 injuries

    The defect has resulted in problems including a procedural delay, difficulty removing device fragments and bleeding, the FDA said.

    By • July 17, 2025
  • Boston Scientific's Farawave pulsed field ablation catheter is shown against a white background.
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    Courtesy of Boston Scientific
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    Boston Scientific gets expanded PFA label for persistent AFib

    Patients whose atrial fibrillation lasts longer than seven days and who do not respond well to drug therapy are now eligible for treatment with the Farapulse pulsed field ablation system.

    By • July 8, 2025