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Biden should send 'clear' message to semiconductor industry on prioritizing medtech, AdvaMed says

The trade group said it's pushing for the prioritization of medtechs, transparency for future allocations to the industry, and actions to ensure the continuity of patient care in the U.S.

CDRH proposes requirement for Philips to submit recall plan for sleep-apnea, ventilator devices

The order would mean Philips would have to submit a plan to repair or replace the device or refund customers.

Hologic, Thermo Fisher, Qiagen quarterly sales beat estimates on COVID-19 test revenue

Still, the companies warned demand for testing will decline quickly for the remainder of 2022. 

CDRH's Shuren expects center to return to normal this year despite ongoing COVID work

Jeff Shuren, the director of the FDA's Center for Devices and Radiological Health, also stressed the need for increased cybersecurity and supply chain funding and authority during an event on April 29.

Earnings week 2: Supply chain shortages slowed ResMed, other medtechs from meeting demand

Philips and ResMed were among several medtechs that listed supply chain shortages as a challenge in earnings calls.

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.

FDA labels Celltrion's latest recall of 310,000 COVID-19 tests as a Class I event

The recall stems from the fact that the emergency authorization of the Point of Care DiaTrust COVID-19 Ag Rapid Test only covers use by laboratories with CLIA certification.

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. 

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.”

ACLA, AdvaMed urge Congress to immediately replenish COVID-19 testing fund

Joining a coalition of more than 60 organizations, the lab and medtech groups warned congressional leaders the funding expiration puts the most vulnerable Americans at risk of losing resources to diagnose new infections.

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.

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.

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.

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. 

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.

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.

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.

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. 

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?"

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.

Updated April 22, 2022

FDA warns about noninvasive prenatal tests, but analysts see minimal industry impact

Given that the FDA's warning involves improper test use and lacks new data, Craig-Hallum analysts expect it to have little impact on Natera, one of the companies competing for the market.

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.

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.

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.

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.