‘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

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

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

Medtronic self-expanding TAVR shows durability benefit over surgery at 5 years, analysis shows

Data from from multiple trials presented at ACC's Scientific Sessions showed the rate of structural valve deterioration at five years with surgery was 4.38% versus 2.57% in patients undergoing transcatheter aortic valve replacement.

By Greg Slabodkin • April 5, 2022

Medtronic posts positive 3-year data in renal denervation ahead of pivotal readout

Recent clinical trial results showed Medtronic's device reduced blood pressure out to three years, but analysts cautioned against using the results as a guide for the upcoming pivotal data.

By Nick Paul Taylor • April 5, 2022

iRhythm builds case for wearable cardiac monitor with data in fainting, TAVR patients

Data presented at ACC's Scientific Sessions show that by using iRhythm's Zio to monitor patients after discharge, physicians reduced hospital stays and potentially improved identification of arrhythmia.

By Nick Paul Taylor • April 4, 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

Modeled TAVR volumes recover but still lag Q1 expectations for Edwards: Jefferies

The analysts estimated Edwards' U.S. transcatheter aortic valve replacement sales increased, but were below the consensus estimate for the first quarter, as procedures started to recover from the winter slump.

By Nick Paul Taylor • April 4, 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

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

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

Pear expects $22M in revenue this year, as it banks on growing adoption of digital therapeutics

Pear still has substantial challenges going forward, as it faces several unknowns about the long-term adoption and reimbursement of its products. The company has been operating at a net loss, seeing a $65 million loss last year.

By Elise Reuter • March 29, 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

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

Stryker, Zimmer don't expect near-term titanium supply impact from Russia-Ukraine war

Both companies have enough titanium to get through 2022 without seeing a negative impact. However, they still face other supply chain concerns, such as semiconductor shortages. 

By Nick Paul Taylor • March 25, 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

ResMed CEO expects another tough quarter as supply chain woes continue

Mick Farrell said the $300 million to $350 million of incremental revenue the company has estimated because of Philips' ongoing recall was still a "reasonable" projection, but would be tougher to hit than last quarter.

By Elise Reuter • 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

'On high alert': Hospitals wary of cyber threats from Russia-Ukraine war

Cybersecurity has always been chronically underfunded in hospitals, even before COVID-19 swallowed up more resources. Now, this major international threat is creating a "perfect storm," one cybersecurity expert said.

By Rebecca Pifer • March 21, 2022

US appeals court rules in favor of Nevro in patent dispute with Boston Scientific

The U.S. Court of Appeals for the Federal Circuit upheld that some of Boston Scientific's neuromodulation patent claims were not valid, notching another win for Nevro in the ongoing litigation between the two companies.

By Elise Reuter • March 21, 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