Policy & Regulation: Page 2
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Roche wins FDA approval for first molecular malaria blood donor screening test
The company is pitching the test as a way to improve the safety and availability of blood.
By Nick Paul Taylor • March 28, 2024 -
FDA hits Renovo with warning letter over reprocessed medical devices
The letter accuses Renovo of adding models other than the ones covered by its 510(k) clearances.
By Nick Paul Taylor • March 27, 2024 -
Trendline
The EU Medical Device Regulation
While the European Union’s MDR went into effect in May 2021, device makers still face a range of uncertainties and potential problems with continued extensions and outstanding questions still in play.
By MedTech Dive staff -
Neuronetics wins FDA clearance for device to treat adolescents with depression
William Blair analysts called the clearance a positive surprise, explaining that the FDA has denied several therapies in the patient population.
By Nick Paul Taylor • March 27, 2024 -
Abbott receives CE mark for 6-year insertable cardiac monitor
The device can continuously monitor a patient’s heart rhythms for either three or six years, depending on users’ needs.
By Nick Paul Taylor • March 26, 2024 -
J&J files for FDA approval of Varipulse pulsed field ablation platform
The company wants to catch up with rival PFA systems from Medtronic and Boston Scientific that have already received FDA authorization.
By Nick Paul Taylor • March 26, 2024 -
Vyaire Medical recalls Airlife resuscitators over defect linked to 2 death reports
The recall covers respiratory support devices made in 2017 or earlier that can fail to provide enough ventilation.
By Nick Paul Taylor • March 22, 2024 -
As FDA’s LDT rule looms, experts warn patients may lose access to critical tests
In testimony to Congress Thursday, industry and patient group leaders described the trade-offs expected from increased FDA oversight of laboratory-developed tests.
By Susan Kelly • March 22, 2024 -
Deka’s automated insulin delivery system, powered by patient-led app, gets FDA clearance
Sequel Med Tech will sell the new system, which integrates with Tidepool’s Loop insulin dosing algorithm.
By Nick Paul Taylor • March 20, 2024 -
FDA stops two manufacturers from importing plastic syringes
The agency issued import alerts to Jiangsu Caina Medical and Jiangsu Shenli Medical Production because their products didn’t meet quality requirements or were different from FDA-authorized versions.
By Nick Paul Taylor • Updated April 8, 2024 -
Deep Dive
6 ways the FDA can improve medical device recalls
Experts said improving how adverse events are tracked and requiring manufacturers to use electronic notifications could make devices safer.
By Elise Reuter • March 18, 2024 -
Fresenius Kabi receives FDA warning letter over issues at ex-Ivenix site
Inspectors found fault with the handling of corrective and preventive actions for the Ivenix Infusion System.
By Nick Paul Taylor • March 15, 2024 -
EPA final rule limits EtO emissions for medical device sterilizers
Medtech companies now have two years to come into compliance with the new regulations.
By Elise Reuter • March 14, 2024 -
Mass General Brigham works with FDA to create brain-computer interface group
The collaborators aim to resolve the clinical, regulatory, coverage and payment questions facing developers of the devices.
By Nick Paul Taylor • March 13, 2024 -
FDA seeks feedback on expansion of premarket cybersecurity guidance
The agency is providing information on cybersecurity requirements for companies seeking authorization of new devices.
By Nick Paul Taylor • March 13, 2024 -
AI to expand medtech portfolios, revenue streams: Moody’s
The rating agency predicts AI will start to have a positive impact on medical device companies in the next two years.
By Nick Paul Taylor • March 12, 2024 -
Deep Dive
Why Cigna is capping cost increases for pricey GLP-1 weight loss drugs
The first-of-its-kind move comes as pharmacy benefit managers continue to try to prove their value to clients, and shows how major players are shoring up to meet sky-high GLP-1 demand.
By Rebecca Pifer • March 11, 2024 -
Medtronic recalls more than 45,000 catheter tubing units after injury reports
The issue, which is linked to 26 injuries, could result in neurological harm or death, FDA said.
By Nick Paul Taylor • March 8, 2024 -
Q&A
AI oversight is top challenge facing global device regulators: FDA official
Melissa Torres, CDRH’s associate director of international affairs, spoke about the importance of the International Medical Device Regulators Forum and how countries are struggling with AI oversight.
By Ricky Zipp • March 8, 2024 -
Dexcom receives FDA clearance for first OTC glucose sensor
The diabetes tech firm is tailoring its software to the 25 million people in the U.S. who have Type 2 diabetes and do not use insulin.
By Nick Paul Taylor • March 6, 2024 -
Dexcom, Novo Nordisk call for FDA input on digital diabetes detection devices
The companies want clarity on what evidence would be needed for new technologies to detect undiagnosed Type 2 diabetes or prediabetes.
By Nick Paul Taylor • March 4, 2024 -
GE Healthcare recalls incubators due to risk of newborns falling
The Food and Drug Administration labeled the recall as a Class I event after a serious injury was reported.
By Nick Paul Taylor • March 4, 2024 -
Boston Scientific gains FDA nod for drug-coated coronary balloon
BTIG analyst Marie Thibault said physicians could rapidly adopt the first-of-its-kind device.
By Susan Kelly • March 1, 2024 -
FDA responds to claim breast implant removal is ‘reasonable’ to cut cancer risk
Experts convened by the American Association of Plastic Surgeons concluded it may be “considered reasonable” to remove textured breast implants to reduce the risk of a rare cancer.
By Nick Paul Taylor • Updated March 4, 2024 -
J&J’s pulsed field ablation system secures European approval
The device maker will vie against rivals Boston Scientific and Medtronic in the market for the new treatment for atrial fibrillation.
By Susan Kelly • Feb. 29, 2024 -
Hologic’s radiographic markers targeted in FDA safety communication
The agency has seen reports the implants can move out of position and break through the skin.
By Nick Paul Taylor • Feb. 28, 2024