FDA
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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 -
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 -
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 -
Courtesy of Abbott
Abbott receives FDA approval for Volt PFA system
Abbott can now compete with Medtronic, Boston Scientific and J&J in the U.S. for the fast-growing pulsed field ablation market.
By Elise Reuter • Dec. 22, 2025 -
Alamy
Abbott receives clearance for heart delivery device in premature babies
Physician feedback has informed a delivery device designed to make procedures safer and easier.
By Nick Paul Taylor • Dec. 22, 2025 -
Getty Images
FDA gets mixed feedback on performance monitoring for AI
Medtech industry groups said the FDA should use existing regulatory and quality tools to monitor performance, while medical groups said device manufacturers should be responsible for monitoring AI.
By Elise Reuter • Dec. 16, 2025 -
Getty Images
FDA needs more staff, authority to oversee device recalls, watchdog finds
“FDA's challenges — such as insufficient staffing — can create inefficiencies in the process and potentially put lives at risk,” the U.S. Government Accountability Office said.
By Elise Reuter • Dec. 15, 2025 -
Getty Images
FDA pilots allowing digital health devices access to CMS payment program
Companies can ask the FDA to waive premarket authorization and investigational device requirements while they collect real-world data in a CMS program.
By Nick Paul Taylor • Dec. 10, 2025 -
Courtesy of Whoop
Deep DiveWhat medtech firms can learn from Whoop’s warning letter
An FDA warning letter about the wearable company’s blood pressure feature raises questions about the blurring lines between medtech and wellness.
By Elise Reuter • Dec. 8, 2025 -
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 -
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
