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

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

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Medical 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

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

Dexcom 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

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

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

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

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

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

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

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

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

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

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

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

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

Philips commits more cash to recall as DOJ issues subpoena

The Dutch conglomerate said Monday that it is cooperating with an April 8 subpoena from the U.S. Department of Justice seeking information related to the Respironics recall of sleep apnea devices and ventilators.

By Nick Paul Taylor • April 25, 2022

FDA warns about noninvasive prenatal tests, but analysts see minimal industry impact

Given that the FDA's warning involves improper test use and lacks new data, Craig-Hallum analysts expect it to have little impact on Natera, one of the companies competing for the market.

By Nick Paul Taylor • April 22, 2022

Medtech survey finds widespread cybersecurity noncompliance despite rising investment

Over 80% of respondents see device security as a competitive advantage and almost every company budgeted more money for it this year. However, 80% view the issue as a "necessary evil" imposed by regulators.

By Nick Paul Taylor • April 21, 2022

Advocacy groups support patient engagement in MDUFA V, raise concerns about device safety

Patient groups are largely supportive of the new agreement, which the FDA will finalize and send to Congress. However, some have raised concerns that the deal is too focused on industry’s interests.

By Elise Reuter • April 20, 2022

Philips investigates reports of 1 death, 4 injuries potentially tied to ventilator recall

"We take these events very seriously and they are still under investigation, so we cannot provide an update yet," a company spokesperson said in an emailed statement.

By Nick Paul Taylor • Updated April 22, 2022

Hospitals blast 'unacceptable' inpatient payment bump

Despite the 3.2% overall hike, hospital groups said net payments to hospitals may decrease due to cuts in other areas. The change in payment rates is expected to have little effect on medtech companies' pricing, analysts said. 

By Shannon Muchmore • April 19, 2022