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

Persistent procedure backlogs point to boost for Stryker and Zimmer: analysts

The findings are in line with recent comments from Abbott Laboratories and Johnson & Johnson executives, who reported a rise in procedure volumes as the impact of omicron waned during the first quarter.

By Nick Paul Taylor • April 21, 2022

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Medical device safety in spotlight after high profile recalls

From Philips’ massive recall of respiratory devices to ongoing health risks with breast implants, medical devices tied to patient harm have put a focus on product safety.

By MedTech Dive staff

Abbott reports $900M Q1 revenue beat on COVID-19 test demand

The company's 2022 guidance now includes testing sales of about $4.5 billion, versus $2.5 billion previously, which it anticipates will largely occur in the first half of the year.

By Greg Slabodkin • April 20, 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

J&J saw 'positive signs' of recovery for medtech, but impact from China surge expected in April, May

Johnson & Johnson's rebound for devices in the second half of 2021 was fueled primarily by international markets. However, that trend did not hold in the first quarter as the U.S. market bounced back, particularly for orthopaedics.

By Ricky Zipp • April 19, 2022

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

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