Pear's VR product for postoperative pain granted FDA STeP designation

The agency's designation under the Safer Technologies Program for medical devices could expedite regulatory review for the virtual reality-based digital therapeutic, one of several products in Pear's pipeline.

By Elise Reuter • April 14, 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

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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

Abbott, Intuitive and J&J start medtech earnings season against a turbulent backdrop

The results will shed light on whether elective surgery recovery is enough to offset a range of headwinds, such as shortages of key components and rising freight costs.

By Nick Paul Taylor • 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The draft guidance, which replaces a 2018 document, sets recommendations for how medical device companies should approach cybersecurity in premarket submissions and maintaining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

‘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

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