FDA
-
Permission granted by Johnson & Johnson
FDA advisory panel votes unanimously against J&J heart shunt
Panelists focused on study data that showed the implant did not improve outcomes in heart failure patients.
By Susan Kelly • Dec. 5, 2025 -
Getty Images
Olympus reinforces advice over device issue linked to 113 serious injuries
The company received complaints that the ligation loop can become unintentionally anchored in place.
By Nick Paul Taylor • Dec. 4, 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 -
Courtesy of Medtronic
Medtronic’s Hugo surgical robot earns FDA clearance
With the U.S. authorization for urologic procedures, “there is now choice” for hospitals that want to expand their robotic programs, a company executive said.
By Susan Kelly • Dec. 4, 2025 -
Alamy
Richard Pazdur, FDA drug czar, to retire from agency
Weeks after being named head of CDER, Pazdur has submitted paperwork to step down at the end of the month, exacerbating what’s already been a turbulent year at the FDA.
By Ben Fidler • Dec. 2, 2025 -
Permission granted by Cleveland Diagnostics
Cleveland Diagnostics wins FDA nod for prostate cancer test
The IsoPSA test is intended to help assess whether patients with elevated PSA levels should go on to receive a biopsy procedure.
By Susan Kelly • Dec. 2, 2025 -
Permission granted by Becton Dickinson
FDA flags risk from dropped BD Alaris pumps after 2 injury reports
BD told customers to immediately remove from use any devices they drop or severely jar.
By Nick Paul Taylor • Dec. 2, 2025 -
Getty Images
Ceribell wins FDA clearance for seizure-detection algorithm in neonates
By acquiring new accounts and expanding into NICUs managed by existing clients, Ceribell calculates it can unlock a $400 million market.
By Nick Paul Taylor • Nov. 25, 2025 -
Permission granted by Zimmer Biomet
Zimmer wins FDA clearance for updated knee robot
Competing with companies including Stryker and J&J, Zimmer has moved to strengthen its position by developing an updated robot.
By Nick Paul Taylor • Nov. 17, 2025 -
Permission granted by Stereotaxis
Stereotaxis nets FDA clearance for redesigned surgical robot
The company also posted weaker third-quarter results, but CEO David Fischel said orders for the new GenesisX system, when fully launched, would outpace the rate for an older model.
By Susan Kelly • Nov. 12, 2025 -
Getty Images
Zimmer wins FDA’s breakthrough status for tech to prevent joint infections
Integrating a controlled-release iodine layer into hip implants could reduce the rate of potentially fatal infections.
By Nick Paul Taylor • Oct. 30, 2025 -
Courtesy of Olympus
Olympus execs talk about import alert, GI robot and AI
CEO Bob White and Chief Strategy Officer Gabriela Kaynor discussed the medtech company’s quality and technology priorities after a year of change.
By Elise Reuter • Oct. 28, 2025 -
Courtesy of HLTH 2025
Top RFK aide lashes out against healthcare industry for profiting off of illness
Calley Means stopped short of accusing hospitals, insurers and drug companies from actively working to keep Americans sick, but said it was an "economic fact" that the companies benefit financially when people are ill.
By Susanna Vogel • Oct. 23, 2025 -
Getty Images
HHS says it can still fire workers despite judge’s order pausing shutdown layoffs
The 982 HHS employees who received reduction-in-force notices are not represented by the unions that are plaintiffs in the case, the department’s head of personnel argued in a court filing.
By Rebecca Pifer • Oct. 20, 2025 -
Courtesy of Abiomed
Cybersecurity triggers another recall of J&J’s Impella heart pump controller
While no patients have been harmed, the FDA categorized the action as a Class I recall because of the potential for serious injury or death.
By Nick Paul Taylor • Oct. 14, 2025 -
Getty Images
Trump administration moves to fire HHS employees amid shutdown
Upwards of 1,000 HHS employees were affected. However, the department has rolled back some of the layoffs at the CDC, where the brunt of the terminations were concentrated.
By Rebecca Pifer • Updated Oct. 14, 2025 -
Courtesy of Medtronic
Intuitive’s challengers continue to advance
Companies creating new robotic platforms marked additional milestones heading into the fourth quarter. Catch up with their progress in this roundup of the latest developments in surgical robotics.
By Susan Kelly • Oct. 10, 2025 -
Elise Reuter/MedTech Dive, data from MedTech Dive
FDA’s presence at AdvaMed conference shrinks amid shutdown
Michelle Tarver, director of the Center for Devices and Radiological Health, and other center officials attended virtually as a government shutdown continues.
By Elise Reuter • Oct. 9, 2025 -
Elise Reuter/MedTech Dive
AdvaMed CEO: ‘Just give us some certainty’
At AdvaMed’s annual conference, CEO Scott Whitaker addressed policy issues around tariffs, FDA staff cuts and the ongoing government shutdown.
By Elise Reuter • Oct. 8, 2025 -
Getty Images
CDRH shares regulatory guidance priorities for the coming 12 months
Use of real-world evidence to support regulatory decisions and predetermined change control plans for medical devices are two areas of focus for the agency.
By Nick Paul Taylor • Oct. 2, 2025 -
Permission granted by SS Innovations
SS Innovations changes course on FDA filing for soft tissue robot
A 510(k) submission now planned for this quarter sets up a potentially faster clearance than the de novo pathway originally planned, the company said.
By Susan Kelly • Oct. 2, 2025 -
Alamy
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 -
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 -
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 -
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
