Policy & Regulation
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LabCorp becomes first company to get EUA for direct-to-consumer test for flu, RSV, COVID-19
The kit allows individuals to self-collect nasal swab samples at home to send to LabCorp, which will test for the presence of influenza A and B, respiratory syncytial virus and SARS-CoV-2.
By Nick Paul Taylor • May 18, 2022 -
Sarah Silbiger via Getty Images
Avanos Medical recall gets Class I label from FDA following patient injury, death reports
The company reported in a recall notice that there have been 60 injuries and 23 patient deaths associated with the Avanos Medical Cortrak 2 Enteral Access System since 2015, according to the FDA.
By Ricky Zipp • May 17, 2022 -
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 one year later.
By MedTech Dive staff -
Sarah Silbiger via Getty Images
FDA posts Class I recall report for 51,000 rapid antigen COVID-19 tests
Woodside Acquisitions recalled two different rapid antigen test kits last month and sent emails to distributors requesting them to immediately return all unused products for a refund.
By Nick Paul Taylor • May 16, 2022 -
Courtesy of Dexcom, Nick Jonas Super Bowl kit
Dexcom, Insulet, Tandem start 2022 with revenue growth after weathering omicron surge
All three diabetes technology companies reported that omicron pressured business in January before easing as the quarter progressed.
By Ricky Zipp • May 13, 2022 -
"Government Accountability Office Building" by kafka4prez is licensed under CC BY-SA 2.0
FDA needs testing enforcement discretion policy to improve crisis response, GAO finds
The U.S. Government Accountability Office has recommended that the FDA develop a policy about when to start and stop enforcement discretion for unauthorized tests to avoid some of the problems it faced during the pandemic.
By Nick Paul Taylor • May 13, 2022 -
Mario Tama via Getty Images
Hospital labor expenses up 37% from pre-pandemic levels in March
Medtech companies including Edwards Lifesciences and Zimmer Biomet expect pressure from hospital staffing shortages to continue through 2022. They're also monitoring if tightening finances will affect system placements.
By Hailey Mensik • May 12, 2022 -
Win McNamee/Staff via Getty Images
House subcommittee debates device remanufacturing definition, sends user-fees bill to next stage
Members of the House Subcommittee on Health passed the user-fees bill by a vote of 30-0 Wednesday, sending the legislation to the full House Committee on Energy and Commerce.
By Elise Reuter • May 12, 2022 -
Sarah Silbiger via Getty Images
Hologic gets FDA approval to challenge Abbott, Roche in transplant testing market
The company plans to work toward approvals of transplant assays for other pathogens including the BK virus and Epstein-Barr virus to provide quantitative assessments of potential threats to patients.
By Nick Paul Taylor • May 12, 2022 -
Carol Highsmith. (2005). "Apex Bldg." [Photo]. Retrieved from Wikimedia Commons.
Medtronic completes Intersect acquisition following FTC order
The Federal Trade Commission required Medtronic to divest a subsidiary of Intersect ENT to complete the deal. Medtronic announced the $1.1 billion acquisition last August.
By Nick Paul Taylor • Updated May 16, 2022 -
Permission granted by Dexcom
Q&ADexcom Chief Tech Officer Leach discusses G7's European launch and FDA review, expanding Dexcom One
The executive also comments on the continuous glucose monitor maker's next steps for the G7 system as well as its plans for reaching new patients and expanding to non-diabetic users.
By Ricky Zipp • May 10, 2022 -
Stefan Zaklin via Getty Images
House user-fees bill details clinical trial diversity, cybersecurity requirements
The legislation would let the FDA bring in $1.78 billion in fee revenue from 2023 to 2027 to fund the review of medical devices. That amount could increase to $1.9 billion if the agency meets certain performance goals.
By Elise Reuter • May 10, 2022 -
Sarah Silbiger via Getty Images
FDA finalizes guidance on clinical feasibility studies of diabetic glycemic control devices
The recommendations come amid an increase in requests for feedback from developers of diabetes devices.
By Nick Paul Taylor • May 9, 2022 -
Permission granted by Insulet
Insulet CEO Petrovic to step down on June 1 due to personal reasons; Hollingshead named sucesssor
Shacey Petrovic, who has served as CEO since 2019, is resigning in the first months of the Omnipod 5 launch, an anticipated product for the diabetes tech space. Jim Hollingshead, an Insulet board member since 2019, will take over.
By Ricky Zipp • May 6, 2022 -
Carl Court via Getty Images
EU task force posts guidance on significant IVDR changes to address a top priority for industry
The guidance will help manufacturers determine if a change to an in-vitro diagnostic is significant and will require certification by a notified body after the new regulations go into effect on May 26.
By Nick Paul Taylor • May 6, 2022 -
Sarah Silbiger via Getty Images
FDA reveals another Class I COVID-19 test recall as SML pulls 209,000 kits from the market
The SML notice comes one week after the FDA shared details of a recall of 311,100 Celltrion tests that may have been sent to unauthorized users that lack CLIA certification.
By Nick Paul Taylor • May 5, 2022 -
Courtesy of Abbott
FDA clears Abbott's 4-in-1 Alinity PCR test for sexually transmitted infections
Abbott is pitching the assay as a way for healthcare providers to gain a fuller picture of a person’s health from a single test and create the optimal treatment plan.
By Nick Paul Taylor • May 5, 2022 -
Retrieved from The White House.
Biden should send 'clear' message to semiconductor industry on prioritizing medtech, AdvaMed says
The trade group said it's pushing for the prioritization of medtechs, transparency for future allocations to the industry, and actions to ensure the continuity of patient care in the U.S.
By Nick Paul Taylor • May 4, 2022 -
CDRH proposes requirement for Philips to submit recall plan for sleep-apnea, ventilator devices
The order would mean Philips would have to submit a plan to repair or replace the device or refund customers.
By Elise Reuter • May 3, 2022 -
Brian Tucker
CDRH's Shuren expects center to return to normal this year despite ongoing COVID work
Jeff Shuren, the director of the FDA's Center for Devices and Radiological Health, also stressed the need for increased cybersecurity and supply chain funding and authority during an event on April 29.
By Ricky Zipp • May 2, 2022 -
Sarah Silbiger via Getty Images
FDA labels Celltrion's latest recall of 310,000 COVID-19 tests as a Class I event
The recall stems from the fact that the emergency authorization of the Point of Care DiaTrust COVID-19 Ag Rapid Test only covers use by laboratories with CLIA certification.
By Nick Paul Taylor • May 2, 2022 -
Medtronic, FDA warn providers of HVAD pump malfunctions nearly 1 year after pulled from market
Medtronic said in a letter to healthcare providers that three patients had pumps exchanged due to malfunctions; two of them died following the swap outs.
By Ricky Zipp • April 29, 2022 -
Medtronic's Covidien has another Class I recall for PB980 ventilators
The event adds to Medtronic’s ongoing product safety issues. In January, CEO Geoff Martha said addressing recalls and patient safety were a “top priority.”
By Ricky Zipp • April 28, 2022 -
Getty via Getty Images
ACLA, AdvaMed urge Congress to immediately replenish COVID-19 testing fund
Joining a coalition of more than 60 organizations, the lab and medtech groups warned congressional leaders the funding expiration puts the most vulnerable Americans at risk of losing resources to diagnose new infections.
By Nick Paul Taylor • April 28, 2022 -
Stefan Zaklin via Getty Images
FDA comes under fire at Senate hearing for lack of MDUFA accountability, transparency
"The agency didn’t meet all its goals from the last time around. And now, the FDA wants double the money for mediocre performance improvements and, for certain devices, longer review times," said Sen. Richard Burr, R-N.C.
By Greg Slabodkin • April 27, 2022 -
Mark Wilson via Getty Images
HHS inspector general rules physician-owned device company poses a low risk of fraud and abuse
Ropes & Gray, the law firm that represented the physicians in the advisory opinion process, said the ruling may benefit medical device innovators that have been shut out of hospitals because they have physician owners.
By Nick Paul Taylor • April 26, 2022
