FDA reveals another Class I COVID-19 test recall as SML pulls 209,000 kits from the market

The SML notice comes one week after the FDA shared details of a recall of 311,100 Celltrion tests that may have been sent to unauthorized users that lack CLIA certification.

By Nick Paul Taylor • May 5, 2022

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. 

By Nick Paul Taylor • May 3, 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.

By Ricky Zipp • May 2, 2022

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.

By Nick Paul Taylor • May 2, 2022

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.

By Nick Paul Taylor • April 28, 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

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

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

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

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

COVID-19 testing landscape changes as omicron subvariant spreads

While BA.2 is spreading in the U.S., there are few signs of a surge at the scale of omicron's peak in January. Nonetheless, Quidel reported record COVID-19 test sales for the first quarter as the FDA makes plans for the pandemic's end.

By Greg Slabodkin • April 18, 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

'One for the record books': Quidel posts $1B in revenue, beating previous high by nearly $200M

Despite the record quarter for the diagnostics company, William Blair analysts wrote Quidel hit the $1 billion mark “for the first and likely last time for quite a while.”

By Greg Slabodkin , Ricky Zipp • Updated May 5, 2022

FDA sees 'appropriate' transition period for COVID-19 test EUAs when public health emergency ends

The FDA is planning to give holders of EUAs for COVID-19 diagnostics and other devices 180 days notice of its intent to end their authorizations, in anticipation of U.S. public health emergency declarations stopping.

By Greg Slabodkin • April 7, 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

CDRH chief: Funding for test makers critical so US not caught flat-footed in next pandemic

Jeff Shuren told a House subcommittee that, to avoid testing shortages in the future, the federal government must "pre-position" manufacturers before demand exceeds supply.

By Greg Slabodkin • April 1, 2022

Hospitals struggle to fill staffing holes in short, long term amid surge in nurse turnover

"This is a bigger workforce shortage than we have ever dealt with," said Gay Landstrom, senior vice president and chief nursing officer of Trinity Health, a nonprofit system with 88 hospitals nationwide.

By Hailey Mensik • March 31, 2022

Long-term health of patients, hospitals at stake as care delays continue

As federal relief funds dwindle and volumes remain stagnant, concerns are mounting about the stability of many providers' operations, especially those lacking robust outpatient services.

By Samantha Liss • March 30, 2022

Plaintiffs sue Ellume over 'ill-gotten gains' from recalled COVID-19 tests

Both plaintiffs in the class action suit bought kits that delivered positive results, disrupting their travel plans, only for other tests to find they were negative.

By Nick Paul Taylor • March 28, 2022

Google launches new search tool for provider appointments, seeks FDA approval for Fitbit feature

The tech giant is working to prop up its healthcare efforts following internal project shakiness that led the company to dismantle its Google Health business last year.

By Rebecca Pifer • March 28, 2022

Abbott awarded $1B US Army contract for COVID-19 antigen tests

The award to Abbott Rapid Dx North America, for an undisclosed quantity of BinaxNOW tests, follows a $306 million contract in January as part of the Biden administration's efforts to purchase 1 billion at-home test kits. 

By Greg Slabodkin • March 25, 2022

The case for hybrid care models

Telehealth is increasingly being woven into healthcare organizations' future plans, giving hope to proponents of hybrid care models.

By Rebecca Pifer • March 22, 2022

FDA grappling with influx of illegal COVID-19 tests entering US

The agency has issued a flurry of recent warnings about diagnostics that have been illegally imported into the country as the demand for at-home coronavirus testing increased with the omicron surge.

By Greg Slabodkin • March 18, 2022