FDA: Page 6
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Retrieved from Hologic on May 23, 2024
Hologic recalls more than 53,000 radiographic markers linked to 71 injuries
The Biozorb devices are staying on the market, but Hologic has asked people to report adverse events such as pain.
By Nick Paul Taylor • May 23, 2024 -
Courtesy of Tandem Diabetes Care
Medicare adviser sets recommendations for diabetes device evidence
A MEDCAC panel found time in range was an “extremely important” metric, but members were divided on whether quality of life measures should influence coverage.
By Elise Reuter • May 22, 2024 -
Explore the Trendline➔
Sitthiphong via Getty Images
TrendlineMedical device industry continues to turn to AI
While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.
By MedTech Dive staff -
Courtesy of Business Wire
Guardant colon cancer test struggles to detect non-cancerous tumors, FDA says
Agency scientists highlighted the risk in materials posted ahead of a Thursday advisory panel meeting for the Guardant Health blood test.
By Susan Kelly • May 22, 2024 -
Carl Court via Getty Images
EMA updates advice on drug-device combinations under MDR, IVDR
The European Medicines Agency answered six new questions to clarify topics such as how companies can get advice on borderline products.
By Nick Paul Taylor • May 22, 2024 -
Courtesy of Boston Scientific
UK backs use of cancer treatment offered by Boston Scientific
A Boston Scientific executive said the guidance will expand access to a minimally invasive treatment for tumors that have metastasized to the liver.
By Nick Paul Taylor • May 20, 2024 -
Sara Silbiger via Getty Images
FDA issues import alerts against 2 more plastic syringe manufacturers
Officials moved to stop the plastic syringes made by two Chinese manufacturers from entering the U.S. after finding quality system failings.
By Nick Paul Taylor • May 17, 2024 -
Permission granted by Becton Dickinson
BD wins FDA approval for cervical cancer screening self-collection kit
Patients can self-collect the samples in locations such as retail pharmacies, which could encourage more people to get tested.
By Nick Paul Taylor • May 17, 2024 -
Courtesy of Getinge
Getinge to limit US sales of heart devices after FDA safety warning
CEO Mattias Perjos said the action will have “some negative financial impact,” but the total effect will depend on customers' response.
By Nick Paul Taylor • May 16, 2024 -
Nick van Bree via Getty Images
US hikes tariffs on medical products from China
The rate increases will apply to equipment including syringes, face masks and surgical gloves.
By Elise Reuter • Updated May 14, 2024 -
Courtesy of Cue Health Press Kit
FDA advises against using Cue Health COVID-19 tests, sends warning letter
Agency inspectors found Cue made unauthorized changes to its COVID-19 kits that “reduced the reliability of the tests.”
By Nick Paul Taylor • May 14, 2024 -
Mario Tama via Getty Images
J&J’s Megadyne discontinues pediatric electrode pad after burn reports
Megadyne discontinued the product globally after receiving four reports of patients being burned in procedures when the electrode pads were used.
By Nick Paul Taylor • May 13, 2024 -
Sarah Silbiger via Getty Images
Route 92 catheter recall tied to 2 injuries, 1 death
The affected devices were manufactured by an outside supplier, not Route 92, and had product quality problems.
By Nick Paul Taylor • May 13, 2024 -
Sarah Silbiger via Getty Images
FDA posts final guidance on remanufacturing medical devices
Nearly three years after publishing draft guidance, the FDA has changed the title and added a section on the regulatory requirements for remanufacturers in the final version of the text.
By Nick Paul Taylor • May 10, 2024 -
Retrieved from The Food and Drug Administration.
How stricter EtO regs could shape the medtech industry
In April, the EPA issued a final rule that would limit emissions of ethylene oxide from device sterilizers. The FDA is also taking actions to help reduce emissions of the toxic sterilant.
By Elise Reuter • May 10, 2024 -
Courtesy of Tandem Diabetes Care
Tandem reports 224 injuries related to faulty insulin pump app
A problem with Tandem’s iPhone app could drain the battery of the connected insulin pump, causing it to power down sooner than expected.
By Nick Paul Taylor • May 9, 2024 -
Courtesy of Getinge
FDA tells providers to stop using Getinge heart devices
After months of safety concerns, the FDA said Getinge has yet to “sufficiently” address the problems and risks.
By Nick Paul Taylor • May 9, 2024 -
Sarah Silbiger via Getty Images
Geneoscopy wins FDA approval for Labcorp-partnered colon cancer test
Evercore and Cowen analysts expect Colosense to have a limited impact on Exact Sciences’ rival Cologuard test.
By Nick Paul Taylor • May 8, 2024 -
Courtesy of Integra
Integra still addressing problems at Boston plant
A third-party audit of the Boston facility identified more issues, forcing Integra to keep Surgimend and Primatrix off the market for the foreseeable future.
By Nick Paul Taylor • May 8, 2024 -
Courtesy of Outset Medical
Outset Medical gets FDA nod for dialysis accessory months after halting sales
Outset paused shipments of its TabloCart with prefiltration last year after receiving a warning letter from the FDA.
By Elise Reuter • May 7, 2024 -
Courtesy of Medtronic
Medtronic wins approval to sell renal denervation device in China
Medtronic expects sales in China of the Symplicity Spyral blood pressure treatment to “be modest in the short-term.”
By Nick Paul Taylor • May 7, 2024 -
Permission granted by Nextbeam
Deep DiveEtO causes cancer. Device sterilizers are scrambling to find alternatives.
No one solution can match the scope and scale of ethylene oxide, but a “multi-pronged approach” can help reduce emissions, an FDA official said.
By Elise Reuter • May 6, 2024 -
Justin Sullivan via Getty Images
FDA qualifies Apple Watch AFib feature for use in clinical trials
Officials will accept atrial fibrillation data collected by the wearable as a secondary endpoint in studies of cardiac ablation devices.
By Nick Paul Taylor • May 6, 2024 -
Ramberg via Getty Images
UK sets out position on regulating AI as a medical device
Some AI products that currently can be put on the market without conformity assessment will move to a higher risk class, requiring more scrutiny.
By Nick Paul Taylor • May 3, 2024 -
sanjeri via Getty Images
Lab test overhaul: FDA to regulate LDTs as medical devices
Stricter review of new tests developed by laboratories is coming, but some fear the changes will be expensive, time-consuming and discourage innovation.
By Susan Kelly • May 3, 2024 -
Retrieved from Food and Drug Administration.
Cardinal receives FDA warning letter over unapproved syringes
The agency has recently increased scrutiny of plastic syringes made in China because of safety concerns, including blocking imports from two Chinese manufacturers.
By Elise Reuter • May 2, 2024
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