FDA
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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 Nick Paul Taylor • July 23, 2025 -
Courtesy of Whoop
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 Elise Reuter • July 18, 2025 -
Explore the Trendline➔
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TrendlineTop 5 stories from MedTech Dive
From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.
By MedTech Dive staff -
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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 Nick Paul Taylor • July 17, 2025 -
Courtesy of Boston Scientific
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 Susan Kelly • July 8, 2025 -
Courtesy of Abiomed
J&J’s Abiomed recalls heart pump controllers after 3 patients die
The FDA published an early alert, which the agency reserves for potentially high-risk issues.
By Nick Paul Taylor • Updated July 8, 2025 -
Ugur Karakoc via Getty Images
Olympus pledges prompt response following FDA import block
Endoscopy devices restricted from import accounted for about 1% of the company’s consolidated revenue in its latest fiscal year, Olympus said.
By Susan Kelly • June 30, 2025 -
Sarah Silbiger via Getty Images
Cook Medical recalls catheters over fault linked to 3 serious injuries
The company began the recall after receiving four field complaints about tip separation before and during use.
By Nick Paul Taylor • June 27, 2025 -
Courtesy of Medtronic
Medtronic recall of capsule delivery devices tied to 33 serious injuries
The Food and Drug Administration published an early alert for the recall on Tuesday. No deaths have been associated with the problem.
By Ricky Zipp • June 25, 2025 -
YakobchukOlena via Getty Images
FDA stops Olympus devices from entering the US
The agency said it issued the import alerts because it “continues to have concerns related to outstanding Quality System regulation violations by Olympus.”
By Nick Paul Taylor • June 25, 2025 -
Stringer via Getty Images
GE Healthcare recalls Carestation devices over ventilation failure risk
The recall affects 15 Carestation models and more than 14,000 individual devices.
By Nick Paul Taylor • June 24, 2025 -
Stock via Getty Images
Q’Apel recalls clot removal device in response to FDA warning letter
Rather than pursuing a new regulatory pathway, Q'Apel said it is discontinuing the recalled system “as part of its strategic shift toward newer technologies.”
By Nick Paul Taylor • June 18, 2025 -
Sarah Silbiger via Getty Images
Zyno recalls infusion pumps over unvalidated software
Customers have been asked to stop using the pumps and wait for someone to contact them about exchanging devices.
By Nick Paul Taylor • June 17, 2025 -
gorodenkoff via Getty Images
Could the FDA take an indirect approach to regulate LDTs?
Attorneys said many questions remain about LDT regulation after the FDA lost its legal fight. A recent warning letter could be a clue to future enforcement.
By Susan Kelly • June 16, 2025 -
Sarah Silbiger via Getty Images
Centerline recalls guidewire over risk of coating being left in patients
Coating for the guidewires could come off and get left in patients, which could result in extended or additional procedures. No serious injuries or deaths have been tied to the recall.
By Nick Paul Taylor • June 16, 2025 -
Courtesy of Medtronic
Medtronic recalls ventilators linked to 2 serious injuries, 1 death
The recall comes more than one year after Medtronic announced it would exit the ventilator market.
By Nick Paul Taylor • June 12, 2025 -
Sarah Silbiger via Getty Images
FDA schedules first public MDUFA VI meeting ahead of negotiations
Officials want to know what current features should be reduced or stopped to “ensure the continued efficiency and effectiveness of the medical device review process.”
By Nick Paul Taylor • June 11, 2025 -
Sascha Schuermann via Getty Images
Baxter recalls Novum pump linked to 1 serious injury
The company has asked users to monitor patients frequently to ensure the appropriate infusion is being delivered.
By Nick Paul Taylor • Updated June 11, 2025 -
Alex Wong / Staff via Getty Images
HHS staffers sue over ‘hopelessly error-ridden’ layoffs
Most of the 10,000 HHS employees let go this spring could qualify for the class, according to lawyers. It’s the latest in a string of litigation against the Trump administration for drastically downsizing the federal workforce.
By Rebecca Pifer • June 5, 2025 -
Sarah Silbiger via Getty Images
Smiths Medical recalls infusion pumps over 3 problems
Smiths has not reported any serious injuries or deaths related to the issues, but the FDA sees a risk of harm.
By Nick Paul Taylor • June 4, 2025 -
Anna Moneymaker / Staff via Getty Images
HHS releases more detailed 2026 budget disclosing scope of cuts
On Friday, the HHS fleshed out a preliminary budget released in the spring and gave new details about which of its programs would be terminated if the Trump administration gets its way.
By Rebecca Pifer • June 2, 2025 -
Mario Guti via Getty Images
Bivacor wins FDA breakthrough nod for titanium total artificial heart
The company has so far treated patients who were weeks or months away from a transplant, but the device is theoretically suitable for longer-term use.
By Nick Paul Taylor • June 2, 2025 -
Courtesy of Boston Scientific
Boston Scientific ends TAVR sales; J&J shares Monarch robot data
Boston Scientific said it would halt worldwide sales of its Acurate devices due to “increased clinical and regulatory requirements.”
By Elise Reuter • May 28, 2025 -
Sarah Silbiger via Getty Images
FDA finds Chinese lab copied or falsified data, endangering patients
The FDA said the findings raise doubts about the reliability and viability of premarket submissions based on the company’s data.
By Nick Paul Taylor • May 28, 2025 -
Permission granted by Becton Dickinson
BD recalls esophagogastric tubes linked to 2 serious injuries, 1 death
A problem when preparing the devices for use can delay diagnosis or treatment, leading BD to update its instructions.
By Nick Paul Taylor • May 27, 2025 -
HadelProductions via Getty Images
Stryker wins FDA clearance for minimally invasive back pain treatment
The company will compete with a device Boston Scientific acquired for $850 million.
By Nick Paul Taylor • May 22, 2025
