FDA


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    Sarah Silbiger via Getty Images
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    FDA issues final guidance on postmarket updates to AI-enabled devices

    By using pre-determined change control plans, manufacturers can update AI-enabled devices without filing an additional FDA submission.

    By Dec. 4, 2024
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    Permission granted by Movano Health
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    Movano receives FDA nod for smart ring’s pulse oximeter feature

    Movano Health plans to market the Evie Ring to organizations that run clinical trials and healthcare companies that are helping patients manage chronic diseases.

    By Dec. 3, 2024
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    Sitthiphong via Getty Images
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    Trendline

    Medical device industry continues to turn to AI

    While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.

    By MedTech Dive staff
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    Noam Galai via Getty Images
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    Advamed CEO stresses need for safety, efficacy after Trump picks Makary to lead FDA

    Martin Makary, a Johns Hopkins surgeon and researcher, has been critical of the FDA. He could have the most influence over device policy among Trump’s nominees.

    By Nov. 27, 2024
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    gorodenkoff via Getty Images
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    Zimmer wins FDA approval for cementless partial knee implant

    The device is established in Europe, where the company said it has a 60% market share, but will be the first product of its type available in the U.S.

    By Nov. 26, 2024
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    Noam Galai via Getty Images
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    Johns Hopkins surgeon Makary is Trump’s pick to lead FDA

    A prolific medical researcher and author, Martin Makary criticized the FDA and CDC for their decision-making during the pandemic, although he describes himself as pro-vaccine.

    By Jonathan Gardner , Ned Pagliarulo • Nov. 24, 2024
  • A white, rectangular sticker device is in front of a blue, pen-shaped device.
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    Courtesy of Medtronic
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    Medtronic nets FDA nod for smart insulin pen app

    The clearance paves the way for the launch of Medtronic’s Smart MDI system, which combines its InPen and Simplera continuous glucose monitor for people who take multiple daily insulin injections.

    By Nov. 22, 2024
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    Sarah Silbiger via Getty Images
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    FDA plan would alert public sooner on high-risk device recalls

    The Center for Devices and Radiological Health’s pilot program is meant to cut the time between the FDA’s awareness of potentially high-risk recalls and when the public is notified.

    By Nov. 22, 2024
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    Rebecca Noble via Getty Images
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    Healthcare industry braces for RFK Jr.

    Kennedy's views on vaccines in particular are causing alarm among some physicians and investors.

    By Susanna Vogel • Nov. 22, 2024
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    Patrik Stollarz / Staff via Getty Images
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    Philips revises ventilator directions after airflow issue tied to 4 injuries

    Aerosol deposits could accumulate on a sensor and affect oxygen delivery, the FDA said in a recall notice. Several of the ventilator models were previously recalled for separate problems.

    By Nov. 21, 2024
  • A picture of Getinge's headquarters building in Gothenburg, Sweden.
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    Courtesy of Getinge
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    FDA warns providers on Getinge devices tied to 17 serious injuries

    Getinge recalled endoscopic vessel harvesting devices after receiving 18 complaints in four months. The FDA added the devices to its shortages list following the recall.

    By Nov. 18, 2024
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    Rebecca Noble via Getty Images
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    Trump nominates RFK Jr. to lead HHS

    The nomination of a prominent vaccine skeptic to the head of the nation’s largest healthcare program is expected to alarm some public health experts.

    By Sydney Halleman • Nov. 14, 2024
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    Stock via Getty Images
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    FDA breakthrough device decisions rebound after recent declines

    The FDA designated 166 products under its breakthrough devices program in its most recent financial year, reversing the downward trend seen as the COVID-19 pandemic eased.

    By Nov. 14, 2024
  • A person head is shown inside GE Healthcare's Signa Magnus MRI machine.
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    Retrieved from GE Healthcare on November 14, 2024
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    GE Healthcare’s head-only MRI scanner cleared by the FDA

    The system is designed to shorten scan times, which may be better for people who struggle to stay still or have claustrophobia, and to detect more subtle abnormalities.

    By Nov. 14, 2024
  • Republican Presidential Nominee Donald Trump Holds Election Night Event In West Palm Beach
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    Win McNamee/Getty Images via Getty Images
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    Advamed CEO congratulates Trump, stresses need for public policy support

    Donald Trump’s election victory comes weeks after the FDA named a new leader for the medical device center and as the agency’s contentious LDT final rule is challenged in court.

    By Nov. 11, 2024
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    Chip Somodevilla via Getty Images
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    How the healthcare industry is reacting to a second Trump term

    Donald Trump’s first term as president was characterized by significant turbulence for government healthcare programs. Here’s how some of the most influential industry groups responded to the Republican’s reelection.

    By Rebecca Pifer • Nov. 11, 2024
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    Retrieved from Aerial Lens on October 10, 2024
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    Baxter to restart second IV fluid production line at hurricane-damaged site

    CFO Joel Grade told investors Friday that Baxter expects an approximately $200 million hit to sales in the fourth quarter from Hurricane Helene's disruption.

    By Nov. 11, 2024
  • A picture of a blue pulsed field ablation catheter against a gray background.
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    Courtesy of Johnson & Johnson
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    J&J wins FDA approval for Varipulse PFA system

    J&J is the third medtech company to gain U.S. approval for pulsed field ablation, a new atrial fibrillation treatment seeing rapid adoption.

    By Nov. 7, 2024
  • President-elect Donald Trump addresses a crowd from a podium at the Palm Beach Convention Center on Nov. 6, 2024, in West Palm Beach, Florida.
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    Chip Somodevilla via Getty Images
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    With Trump victorious, biotech industry’s focus turns to his plans for FDA, FTC

    The president-elect has said he’ll let Robert F. Kennedy Jr. “go wild” on healthcare, while many expect a leadership change at the FTC could lower M&A scrutiny.

    By Ned Pagliarulo , Ben Fidler • Nov. 7, 2024
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    Thomas Andreas via Getty Images
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    Advamed asks CMS to cover extra imaging of dense breast tissue

    Many patients with dense breast tissue currently have to pay out of pocket or forgo potentially life-saving additional testing, Advamed said in a letter.

    By Nov. 6, 2024
  • A doctor puts a pulse oximeter on a patient's finger
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    Wavebreakmedia via Getty Images
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    Medtronic settles pulse oximetry lawsuit alleging inaccuracies

    Roots Community Health has sued 12 other firms, including GE Healthcare, CVS and Walgreens, and called for manufacturers and the FDA to ensure the devices work for everyone.

    By Nov. 4, 2024
  • iRhythm's Zio AT cardiac monitor is shown against a white background.
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    Retrieved from iRhythm on October 22, 2024
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    FDA clears iRhythm’s second 510(k) in response to warning letter

    However, the company said it will delay a submission for its next-generation Zio cardiac monitoring system until remediation efforts are further along.

    By Nov. 1, 2024
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    Elise Reuter/MedTech Dive
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    Michelle Tarver faces challenges as new CDRH leader. But patient groups, industry are optimistic.

    Patient advocates are hoping for change under new director Michelle Tarver, while industry groups look to build on former director Jeff Shuren’s leadership.

    By Oct. 31, 2024
  • The AI Pavilion at HLTH 2024 in Las Vegas.
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    Emily Olsen/MedTech Dive
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    Deep Dive

    AI could be a game changer, but healthcare needs to be ‘exceedingly careful’

    Artificial intelligence tools could help solve workforce challenges. Implementation, however, can be difficult, pushing organizations to consider less risky administrative and back-office tasks first.

    By Emily Olsen • Oct. 29, 2024
  • A person holds a clear, spiral shaped device with metal dots.
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    Retrieved from Hologic on May 23, 2024
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    FDA advises clinicians to stop using Hologic radiographic markers

    Hologic has recalled the Biozorb devices after 188 reports of adverse events in patients who received the implants in breast tissue.

    By Oct. 28, 2024
  • Medtronic's Affera all-in-one ablation system
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    Courtesy of Medtronic
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    Medtronic wins FDA approval for Affera mapping and ablation system

    Affera combines mapping technology with a catheter capable of performing radiofrequency and pulsed field ablation.

    By Oct. 25, 2024