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

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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

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

FDA clarifies cybersecurity recommendations for device makers in new guidance

The draft guidance, which replaces a 2018 document, sets recommendations for how medical device companies should approach cybersecurity in premarket submissions and maintaining products throughout their lifecycle.

By Elise Reuter • April 7, 2022

FDA sees 'appropriate' transition period for COVID-19 test EUAs when public health emergency ends

The FDA is planning to give holders of EUAs for COVID-19 diagnostics and other devices 180 days notice of its intent to end their authorizations, in anticipation of U.S. public health emergency declarations stopping.

By Greg Slabodkin • April 7, 2022

‘Where’s the patient?’: Experts question FDA’s final recall guidance

While the guidance encouraged the use of electronic communications in recalls — a change experts have advocated for — some questioned why the agency did not address more problems with the system.

By Ricky Zipp • April 6, 2022

Senators drill down on rising user fees, cybersecurity and clinical trial diversity in MDUFA hearing

While Tuesday's Senate hearing did not include FDA officials, lawmakers questioned industry groups as they consider the MDUFA V agreement that would increase the amount the agency can collect in fees from device makers.

By Elise Reuter • April 6, 2022

After seeing reprocessed duodenoscope contamination data, FDA pushes for switch to disposable

Manufacturers are pulling fixed endcap duodenoscopes after postmarket surveillance studies found a portion of samples tested positive with organisms such as E. coli.

By Nick Paul Taylor • April 6, 2022

Nearly 80% of patients with infection following cardiac implant not treated appropriately: study

A Duke University study, which was supported by Philips, showed that roughly four out of five patients with an infection following a cardiac implant did not have devices extracted, which goes against clinical guidelines.

By Ricky Zipp • April 5, 2022

Medical device user fee update inches closer to approval

After the FDA was delayed in getting a draft to Congress, the House and the Senate are working to pass legislation that would reauthorize the fifth Medical Device User Fee Amendments.

By Elise Reuter • Updated June 21, 2022

Medtronic recalls IN.PACT catheters due to damage during manufacturing

The medtech giant's latest recall adds to a growing list of product safety problems. Medtronic said no patient injuries or deaths have been reported.

By Ricky Zipp • April 1, 2022

CDRH chief: Funding for test makers critical so US not caught flat-footed in next pandemic

Jeff Shuren told a House subcommittee that, to avoid testing shortages in the future, the federal government must "pre-position" manufacturers before demand exceeds supply.

By Greg Slabodkin • April 1, 2022

Congress questions FDA, industry over MDUFA V delays

Members of the House Subcommittee on Health reminded both groups that the Jan. 15 deadline, which the FDA and the medical device industry missed by more than two months, "is not a mere suggestion."

By Elise Reuter • March 31, 2022

Long-term health of patients, hospitals at stake as care delays continue

As federal relief funds dwindle and volumes remain stagnant, concerns are mounting about the stability of many providers' operations, especially those lacking robust outpatient services.

By Samantha Liss • March 30, 2022

Notified body update dampens hopes of near-term surge in IVDR capacity

The European Commission's update reveals a growing pipeline of submissions that are approaching MDR designation but little hope of a near-term surge of in-vitro diagnostic capacity. 

By Nick Paul Taylor • March 30, 2022

FDA asks Congress for 14% bump in device budget for supply chain, cybersecurity programs

For the devices program, the FDA is asking for roughly $698 million, with approximately $466 million from the budget authority and $232 million from user fees.

By Nick Paul Taylor • March 29, 2022

Plaintiffs sue Ellume over 'ill-gotten gains' from recalled COVID-19 tests

Both plaintiffs in the class action suit bought kits that delivered positive results, disrupting their travel plans, only for other tests to find they were negative.

By Nick Paul Taylor • March 28, 2022

MDR updates safety, clinical performance requirement for high-risk devices

The guidance from a European Commission panel covers the requirement for manufacturers to draw up a summary of safety and clinical performance for implantable and Class III devices, which are higher risk. 

By Nick Paul Taylor • March 28, 2022

Congressman asks FDA for information on oversight of Medtronic's troubled HVAD

Nine months after Medtronic pulled the system off the market, Rep. Raja Krishnamoorthi is asking the FDA to provide information about how the device was regulated following reports of patient injuries and deaths.

By Ricky Zipp • March 25, 2022

FDA urges COVID-19 test makers with EUAs to seek full authorizations

Tim Stenzel, head of the Office of In Vitro Diagnostics and Radiological Health, told developers it's time to "get in line" for premarket review to ensure products can be marketed beyond the public health emergency.

By Greg Slabodkin • March 24, 2022

FDA sets terms for MDUFA V agreement

The agency reached a belated agreement with industry over how much it will get to review medical products. It will receive at least $1.78 billion over the next five years, but could get up to $1.9 billion if it meets certain performance goals.

By Elise Reuter • March 23, 2022