Policy & Regulation
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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 -
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 -
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 -
Natera secures Medicare coverage for cancer test in 2 new indications
Natera met the coverage requirements for ovarian cancer in adjuvant and surveillance settings and for breast cancer in the neoadjuvant setting.
By Nick Paul Taylor • Feb. 27, 2024 -
Virtual Incision wins FDA de novo nod for miniaturized surgical robot
The device weighs about two pounds and fits into a tray that can be carried between operating rooms.
By Nick Paul Taylor • Feb. 27, 2024 -
European Council approves extension of IVDR transition
The Council expects the European Parliament to vote on the plan, without seeking amendments, in April.
By Nick Paul Taylor • Feb. 26, 2024 -
FDA warns against using smart wearables that claim to measure blood sugar
Unauthorized smartwatches and smart rings are “manufactured by dozens of companies and sold under multiple brand names,” according to the agency.
By Nick Paul Taylor • Feb. 23, 2024 -
Better Therapeutics wins breakthrough status for health app to treat liver disease
The FDA awarded the designation after seeing evidence the digital cognitive behavioral therapy may help reduce liver fat.
By Nick Paul Taylor • Feb. 21, 2024 -
CDRH’s Shuren backs expansion of TAP program to speed device approval
The FDA started the Total Product Lifecycle Advisory Program to help medtech companies cross the “valley of death” by getting agency feedback early.
By Elise Reuter • Feb. 21, 2024 -
FDA warns industry of ‘fraudulent’ third-party data in device applications
The agency has seen a rise in data that are fabricated, duplicated or otherwise unreliable in premarket submissions.
By Nick Paul Taylor • Feb. 21, 2024 -
Medical device recall system ‘failing to meet the needs of public health,’ physicians find
Amid a GAO review of recalls, the physicians advised the watchdog to revisit unique device identifiers and clarify the FDA’s enforcement authority.
By Nick Paul Taylor • Feb. 20, 2024 -
UK medical device reviewers form new association
The group intends to help the medical device sector navigate a post-Brexit regulatory landscape.
By Susan Kelly • Feb. 20, 2024