FDA: Page 10
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Sarah Silbiger via Getty Images
Teleflex catheter kit recall linked to 31 injuries, 3 deaths
Teleflex reported 322 complaints about a safety problem that can prevent the balloon from fully inflating.
By Nick Paul Taylor • June 14, 2024 -
Courtesy of Philips
Philips launches stent system to restore blood flow in blocked veins
Philips acquired the device as part of its 227 million euro purchase of Vesper Medical in 2022.
By Nick Paul Taylor • June 13, 2024 -
Courtesy of Johnson & Johnson
J&J wins expanded FDA clearance for knee surgery robot
Johnson & Johnson has identified Velys as a product that can help it regain market share from rivals such as Stryker.
By Nick Paul Taylor • June 10, 2024 -
Courtesy of Abbott
Abbott wins CE mark for dual-chamber leadless pacemaker
Abbott sees the device as a product that can help its rhythm management business grow 6% to 7%.
By Nick Paul Taylor • June 7, 2024 -
Permission granted by ECRI
Q&AStronger oversight of AI needed in medical devices, ECRI CEO says
Marcus Schabacker called for more upfront regulations and postmarket monitoring to better understand how AI features affect patient care.
By Elise Reuter • June 5, 2024 -
K-Kwanchai via Getty Images
Lab industry sues to stop FDA’s new LDT rule
The American Clinical Laboratory Association argues the agency does not have the authority to enforce stricter standards on lab developed tests.
By Susan Kelly • May 30, 2024 -
Courtesy of Intuitive Surgical
New products take center stage in medtech’s latest earnings season
From pulsed field ablation devices to Intuitive's latest da Vinci robot, product launches dominated recent earnings calls.
By Ricky Zipp • May 28, 2024 -
Sarah Silbiger via Getty Images
Medline, Chinese manufacturer launch recalls for plastic syringes
Medline and Jiangsu Shenli Medical Production are at the center of the FDA’s probe of plastic syringes made in China.
By Ricky Zipp • May 24, 2024 -
Courtesy of GuardantHealth
FDA panel backs Guardant’s blood test for colon cancer
“The favorable panel vote does not by any means imply this test will become an overnight success,” wrote William Blair analyst Andrew Brackmann.
By Susan Kelly • May 24, 2024 -
Ramberg via Getty Images
UK regulator proposes recognizing overseas medical device approvals
Companies with authorization in certain regions, including the EU and U.S., would be able to use their approvals to access Great Britain’s market.
By Nick Paul Taylor • May 24, 2024 -
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 -
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
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