FDA: Page 13
-
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 -
Explore the Trendline➔
Permission granted by Boston Scientific
TrendlineNew medical devices are reshaping the medtech industry
From pulsed field ablation devices to glucose sensors and surgical robotics, new medical technologies are transforming patient care and how people manage their health.
By MedTech Dive staff -
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 -
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Nearly three years after publishing draft guidance, the FDA has changed the title and added a section on the regulatory requirements for remanufacturers in the final version of the text.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 -
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 -
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 -
Permission granted by Senseonics
Senseonics gets FDA clearance to pair CGM implant with insulin pumps
Analysts said the designation and planned one-year sensor could help Senseonics’ device appeal to more patients.
By Nick Paul Taylor • May 1, 2024 -
Jon Cherry via Getty Images
FDA defends LDT final rule, while critics fear it upends lab industry
The new policy aims to ensure important diagnostics remain available to patients, but some experts caution the increased regulatory burdens could slow access to testing.
By Susan Kelly • April 30, 2024 -
Justin Sullivan via Getty Images
Labcorp gains FDA approval for companion diagnostic to Pfizer gene therapy
The test would determine if patients are eligible for Pfizer’s new hemophilia B treatment by detecting if they have been exposed to a virus that could make the gene therapy less effective.
By Nick Paul Taylor • April 30, 2024 -
Courtesy of Abbott Laboratories
Abbott wins FDA approval for Esprit resorbable scaffold
While RBC analysts wrote there’s “strong appetite” for the system, BTIG said the need to train centers could result in a gradual launch.
By Nick Paul Taylor • April 30, 2024 -
Getty Images
FDA finalizes lab developed test rule despite industry opposition
Risks associated with the tests have increased, requiring greater oversight to protect patients, the agency contends.
By Susan Kelly • April 29, 2024 -
Courtesy of Medtronic
Medtronic wins FDA approval for Inceptiv closed-loop spinal cord stimulator
Evercore analysts said the launch could help Medtronic regain market share in the coming quarters.
By Nick Paul Taylor • April 29, 2024 -
Courtesy of Fresenius Medical Care
Fresenius Medical Care recalls 2M dialysis devices over toxin exposure risk
Nearly 2.2 million devices are affected by the recall. Fresenius Medical Care will not have to remove products due to the issue.
By Nick Paul Taylor • April 26, 2024 -
Courtesy of U.S. Food and Drug Administration
Infutronix infusion pump recall linked to 6 injuries, 1 death
The FDA’s recall notice sheds light on the impact to patients weeks after the company told customers it would pull Nimbus pumps from the market.
By Nick Paul Taylor • April 26, 2024 -
Patrik Stollarz / Staff via Getty Images
Philips failed to report corrections of CT machines, FDA says in warning letter
After a 2023 inspection, the FDA found three unreported field corrections related to CT machines and 19 other recalls of radiology devices.
By Elise Reuter • April 25, 2024
Previous
