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

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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

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

Another Philips ventilator recall gets Class I label from the FDA

The recall began when the company discovered that some ventilators were assembled using expired adhesive, the failure of which could lead to injuries to patients. The FDA is treating the problem as a high-risk event.

By Nick Paul Taylor • March 23, 2022

FDA labels Philips 2018 field correction for ventilators a Class I recall

The company issued a field correction in 2018 for certain devices due to sound abatement foam degrading, the same issue spurring its 2021 recall of millions of devices. However, the company never notified the FDA.

By Ricky Zipp • March 22, 2022

Dexcom's hospital glucose monitor leads latest FDA breakthrough designations

The regulatory privileges were granted to Dexcom after its at-home glucose monitors were allowed to be used in hospitals during the pandemic. AltPep, CardioStory, Insightec and Merit were also among the designations this month.

By Nick Paul Taylor • March 22, 2022

FDA grappling with influx of illegal COVID-19 tests entering US

The agency has issued a flurry of recent warnings about diagnostics that have been illegally imported into the country as the demand for at-home coronavirus testing increased with the omicron surge.

By Greg Slabodkin • March 18, 2022

What's holding up hospital at home?

Widespread adoption of acute-level care at home models has been hampered by physician reluctance and patchwork reimbursement, though a CMS waiver caused hospital participation to snowball during the pandemic.

By Rebecca Pifer • March 18, 2022

Illumina sues Guardant CEOs over trade secrets, sparking counterblast against 'retaliatory' lawsuit

Guardant called the lawsuit "frivolous and retaliatory" and framed it as a response to its concerns about the Illumina-Grail merger.

By Nick Paul Taylor • March 18, 2022

As White House warns of 'squandering' gains, AdvaMed sets out plan to sustain COVID-19 test capacity

The medtech lobby is calling for the creation of a permanent public-private diagnostic testing forum and warm-base manufacturing agreements to maintain testing capacity in the event of future surges. 

By Nick Paul Taylor • March 17, 2022

'Not for the faint of heart': Insulet CEO talks Tandem and Medtronic competition, Omnipod 5 launch

Shacey Petrovic spoke to MedTech Dive about the long-awaited launch of its insulin pump, competitors' developing patch pumps and how the Ukraine crisis will impact the industry.

By Ricky Zipp • March 17, 2022