FDA
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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 -
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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 -
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TrendlineMedical device safety in spotlight after high profile recalls
From Philips’ massive recall of respiratory devices to ongoing health risks with breast implants, medical devices tied to patient harm have put a focus on product safety.
By MedTech Dive staff -
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 -
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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 -
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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 -
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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 -
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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 -
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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 -
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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 -
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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 -
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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 -
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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 -
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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 -
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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 -
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FDA sets stricter approval standards for COVID vaccines
The agency will now require randomized, controlled data before approving new COVID shots for healthy children and adults, Commissioner Martin Makary and top vaccine official Vinay Prasad wrote in NEJM.
By Delilah Alvarado • May 20, 2025 -
Sarah Silbiger/Getty Images via Getty Images
FDA clears first blood test to aid Alzheimer’s diagnosis
The FDA cleared the test for the early detection of amyloid plaques associated with Alzheimer’s in people aged 55 years and older with signs and symptoms of the disease.
By Nick Paul Taylor • May 19, 2025 -
Retrieved from Teal Health on May 13, 2025
Teal wins FDA approval for at-home cervical cancer screening device
The company plans to start shipping the device in June, starting in California and then expanding nationwide.
By Nick Paul Taylor • May 13, 2025 -
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FDA, aiming to speed scientific reviews, names chief AI officer
Commissioner Martin Makary also said the agency would roll out a generative AI system across its centers that will help FDA scientists spend less time on repetitive tasks.
By Susan Kelly • May 9, 2025 -
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AdvaMed calls for ‘zero for zero’ medtech tariffs between US and UK
AdvaMed and its British counterpart called for urgent action to ensure the situation “does not devolve into a crisis.”
By Nick Paul Taylor • May 7, 2025
