FDA
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More than 1,100 devices have received the FDA’s breakthrough designation
The FDA updated its list of breakthrough devices as medtech groups lobby for faster Medicare coverage of products with the designation.
By Elise Reuter • Aug. 21, 2025 -
Permission granted by Aktiia
Q&AHow Aktiia built the first over-the-counter cuffless blood pressure monitor
Aktiia received FDA clearance in July for the first cuffless blood pressure monitor authorized to be sold over the counter.
By Elise Reuter • Aug. 20, 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 -
Permission granted by NeuroOne
NeuroOne gains FDA clearance for trigeminal nerve ablation
The minimally invasive system uses radiofrequency energy to target nerve tissue causing facial pain.
By Susan Kelly • Aug. 20, 2025 -
Alamy
Medtronic recall of heart vent catheters tied to 3 serious injuries
The FDA said the request to quarantine the devices followed reports of the products “resisting shape retention when being bent.”
By Nick Paul Taylor • Aug. 19, 2025 -
Courtesy of Boston Scientific
Boston Scientific updates instructions of devices linked to 17 deaths
The update covers devices used in procedures to implant the company’s Watchman heart device.
By Nick Paul Taylor • Aug. 8, 2025 -
Alamy
Boston Scientific tells users about defibrillator problem linked to deaths, injuries
A company spokesperson said in a statement to MedTech Dive that direct causation between the deaths and calcification of the leads cannot be assumed or confirmed.
By Nick Paul Taylor • Aug. 7, 2025 -
Elise Reuter/MedTech Dive
Medical device industry says future MDUFA hikes unsustainable
Device lobbyists’ priorities contrasted with patient advocates, who sought an increase in user fees and more funds for postmarket safety.
By Elise Reuter • Aug. 5, 2025 -
Permission granted by Monogram Technologies
News roundupMonogram robot marks autonomy milestone; Stereotaxis catheter cleared
Monogram Technologies conducted its first fully autonomous robotic knee replacement surgery, while Stereotaxis won FDA clearance for a robotically navigated electrophysiology mapping catheter.
By Susan Kelly • July 31, 2025 -
hapabapa via Getty Images
Cardiosense wins FDA clearance for wearable heart monitor
The device captures various types of heart data that could be used in AI models for cardiovascular parameters with the aim of lowering barriers to monitoring.
By Nick Paul Taylor • July 31, 2025 -
Alamy
Edwards recalls arterial cannulas over exposed wires
Exposed wires could puncture the artery and cause bleeding, inadequate perfusion and hemolysis, the FDA said in its Class I recall notice.
By Nick Paul Taylor • July 25, 2025 -
Sascha Schuermann via Getty Images
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 -
Sarah Silbiger via Getty Images
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
