GE Healthcare, Medtronic turn to outpatient care in new partnership

The companies agreed to a collaboration on ambulatory surgery centers and office-based labs as more procedures are shifting to outpatient care settings. 

By Elise Reuter • April 29, 2022

Medtronic, FDA warn providers of HVAD pump malfunctions nearly 1 year after pulled from market

Medtronic said in a letter to healthcare providers that three patients had pumps exchanged due to malfunctions; two of them died following the swap outs.

By Ricky Zipp • April 29, 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

Medtronic's Covidien has another Class I recall for PB980 ventilators

The event adds to Medtronic’s ongoing product safety issues. In January, CEO Geoff Martha said addressing recalls and patient safety were a “top priority.”

By Ricky Zipp • April 28, 2022

Edwards sees boost in TAVR volumes; CEO says hospitals 'still recovering' from the pandemic

The company's U.S. sales for transcatheter aortic valve replacement devices increased by 10% year over year, estimating a similar jump in procedures.

By Elise Reuter • April 27, 2022

FDA comes under fire at Senate hearing for lack of MDUFA accountability, transparency

"The agency didn’t meet all its goals from the last time around. And now, the FDA wants double the money for mediocre performance improvements and, for certain devices, longer review times," said Sen. Richard Burr, R-N.C.

By Greg Slabodkin • April 27, 2022

Boston Scientific expects more stable 2022 as procedure volumes recover

CEO Michael Mahoney told investors during a first-quarter earnings call the medtech doesn't anticipate as volatile a year as 2021 as most regions are recovering from the pandemic.

By Ricky Zipp • April 27, 2022

GE Healthcare hit by supply chain constraints, inflation pressures

"We're operating in a challenging macro environment," GE CEO Larry Culp said during a first-quarter earnings call, while also noting COVID-19 lockdowns in China and lower sales volumes in Russia and Ukraine impacted results. 

By Greg Slabodkin • April 26, 2022

HHS inspector general rules physician-owned device company poses a low risk of fraud and abuse

Ropes & Gray, the law firm that represented the physicians in the advisory opinion process, said the ruling may benefit medical device innovators that have been shut out of hospitals because they have physician owners.

By Nick Paul Taylor • April 26, 2022

Philips commits more cash to recall as DOJ issues subpoena

The Dutch conglomerate said Monday that it is cooperating with an April 8 subpoena from the U.S. Department of Justice seeking information related to the Respironics recall of sleep apnea devices and ventilators.

By Nick Paul Taylor • April 25, 2022

Will early trends reported by J&J, Abbott and Intuitive hold in week 2 of earnings?

All three medtechs reported that procedure volumes returned later in the quarter following an omicron-pressured January, and Wall Street analysts say others are likely to report a similar trend.

By Ricky Zipp • April 25, 2022

Solving one of the biggest challenges in healthcare

The treatment pathway for autoimmune diseases is broken. Precision medicine can help.

April 25, 2022

Intuitive sees double-digit procedure growth, warns of slowing hospital placements

The surgical robotics company saw a 16% increase in procedure volumes in the U.S., but placements of its da Vinci robots came in below consensus expectations. 

By Elise Reuter • April 22, 2022

Globus Medical CEO resigns in 'surprise' move; stock slips roughly 13%

Dave Demski is stepping down effective immediately after spending nearly 20 years with the company and over four as the CEO. BTIG analysts called the move a surprise, writing that investors will likely be asking, "why now?"

By Ricky Zipp • April 22, 2022

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

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