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

Explore the Trendline➔

Top 5 stories from MedTech Dive

From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.

By MedTech Dive staff

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

FDA authorizes first COVID-19 breathalyzer test, clearing path to 3-minute results

After researchers began looking into ways to detect COVID-19 in breath samples, InspectIR Systems’ test will be the first FDA-authorized breathalyzer. 

By Nick Paul Taylor • April 18, 2022

COVID-19 testing landscape changes as omicron subvariant spreads

While BA.2 is spreading in the U.S., there are few signs of a surge at the scale of omicron’s peak in January. Nonetheless, Quidel reported record COVID-19 test sales for the first quarter as the FDA makes plans for the pandemic’s end.

By Greg Slabodkin • April 18, 2022

With IVDR looming, EU prioritizes guidance on legacy devices and Eudamed transition

A staggered implementation of IVDR has left questions about how legacy tests put on the market will be regulated, and how information will be exchanged until the Eudamed medical device database is fully functional. 

By Nick Paul Taylor • April 13, 2022

California appeals court orders J&J to pay $302M for deceptive surgical mesh marketing

A federal appeals court found Johnson & Johnson subsidiary Ethicon deceptively marketed its pelvic mesh devices, minimizing the health risks. The company said in an emailed statement that it plans to appeal the decision.

By Elise Reuter • April 12, 2022

Majority of diagnostic companies still implementing IVDR as deadline nears: survey

Eighty-five percent of respondents said they are implementing the new requirements, finds a survey from Climedo Health and TRIGA-S Scientific Solutions. But most are either familiar or very familiar with the regulations.

By Ricky Zipp • April 12, 2022

FDA official: Draft cybersecurity guidance has ‘teeth’

Not following the guidance in premarket submissions means potential delays for device makers, said Suzanne Schwartz, director of CDRH’s Office of Strategic Partnerships and Technology Innovation.

By Greg Slabodkin • April 11, 2022

Medtronic’s recall of over 175,000 MiniMed pumps labeled Class II by FDA

The recall, which will not require the retrieval of any devices, has been associated with serious injuries and one death, according to the company. Medtronic said an independent review did not attribute the death to the issue.

By Ricky Zipp • Updated April 8, 2022