FDA: Page 3

  • A person wears a small, white round sensor on their forearm.
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    Courtesy of Biolinq
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    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 • Updated Sept. 29, 2025
  • Heartflow
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    Courtesy of HeartFlow
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    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 • Sept. 25, 2025
  • Boston Scientific's Farapulse pulsed field ablation device. Explore the Trendline➔
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    Permission granted by Boston Scientific
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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
  • illustration of a heart showing a tube-shaped device going into the left ventricle
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    Courtesy of Abiomed
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    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 • Sept. 24, 2025
  • A modern two-story commercial office building with a mix of gray and wood paneling on the exterior. Large glass windows dominate both floors, and the front entrance features the "Medtronic" logo above double glass doors. The surrounding area includes a few small shrubs and empty parking spaces in front.
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    Alamy
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    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 • Sept. 22, 2025
  • Modern glass and metal office building with a reflective blue-tinted facade, set against a clear blue sky. In the foreground, a large black and white sign reads “Abbott” with the company’s stylized logo and the number “645.” The area has neatly cut grass and a few small trees.
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    Alamy
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    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 • Updated Sept. 22, 2025
  • Food And Drug Administration Headquarters In Maryland
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    Sarah Silbiger via Getty Images
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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 • Updated Sept. 18, 2025
  • Becton Dickinson logo
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    Permission granted by Becton Dickinson
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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
  • A sign for the FDA is shown in front of the headquarters building in Silver Spring, Maryland.
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    Getty Images
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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
  • A close-up of a person in a suit looking off to the right.
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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 Parduhn • 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
  • A person stands outside wearing a small, square device with a cord on their belt.
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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
  • illustration of a heart showing a tube-shaped device going into the left ventricle
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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
  • Front sign of FDA building
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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
  • A person wearing a black wristband holds a phone that says "103/65"
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    Permission granted by Aktiia
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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
  • NeuroOne
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    Permission granted by NeuroOne
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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
  • A modern two-story commercial office building with a mix of gray and wood paneling on the exterior. Large glass windows dominate both floors, and the front entrance features the "Medtronic" logo above double glass doors. The surrounding area includes a few small shrubs and empty parking spaces in front.
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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
  • A commercial building displays a “Boston Scientific” sign on its exterior. The structure features a smooth white facade with reflective windows and minimal architectural detailing, set against a partly cloudy sky.
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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
  • A person speaks at a podium.
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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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    Permission granted by Monogram Technologies
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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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    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