Diagnostics

FDA user-fee bill goes to House; Senate committee draft revamps diagnostic regulations

The House Energy and Commerce Committee unanimously passed a bill to reauthorize the FDA’s user-fee amendments for the next five years. A Senate committee draft of the bill would add substantive changes.

By Elise Reuter • May 19, 2022

LabCorp becomes first company to get EUA for direct-to-consumer test for flu, RSV, COVID-19

The kit allows individuals to self-collect nasal swab samples at home to send to LabCorp, which will test for the presence of influenza A and B, respiratory syncytial virus and SARS-CoV-2.

By Nick Paul Taylor • May 18, 2022

Explore the Trendline➔

COVID-19 diagnostics surge as industry prepares for spike in at-home testing

With strong demand once again for rapid at-home coronavirus tests, medtech companies are looking beyond COVID-19 to sell over-the-counter and direct-to-consumer diagnostics for other diseases. 

By MedTech Dive staff

FDA posts Class I recall report for 51,000 rapid antigen COVID-19 tests

Woodside Acquisitions recalled two different rapid antigen test kits last month and sent emails to distributors requesting them to immediately return all unused products for a refund.

By Nick Paul Taylor • May 16, 2022

FDA needs testing enforcement discretion policy to improve crisis response, GAO finds

The U.S. Government Accountability Office has recommended that the FDA develop a policy about when to start and stop enforcement discretion for unauthorized tests to avoid some of the problems it faced during the pandemic.

By Nick Paul Taylor • May 13, 2022

Hologic gets FDA approval to challenge Abbott, Roche in transplant testing market

The company plans to work toward approvals of transplant assays for other pathogens including the BK virus and Epstein-Barr virus to provide quantitative assessments of potential threats to patients.

By Nick Paul Taylor • May 12, 2022

Roundup: As procedures rebound, supply chain, staffing challenges set to continue for medtechs

Procedure-driven companies saw sales recover at the end of the first quarter, while diagnostics businesses reported increased sales of COVID-19 tests due to the omicron surge in January.

By Elise Reuter • Updated May 19, 2022

Earnings week 3: Procedure rebounds, stock price declines, iRhythm's comeback

AtriCure and Axonics reported procedure volume rebounds and both firms increased their 2022 forecasts. Still, the share prices of the companies dropped late last week.

By Ricky Zipp • May 9, 2022

EU task force posts guidance on significant IVDR changes to address a top priority for industry

The guidance will help manufacturers determine if a change to an in-vitro diagnostic is significant and will require certification by a notified body after the new regulations go into effect on May 26. 

By Nick Paul Taylor • May 6, 2022

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

FDA clears Abbott's 4-in-1 Alinity PCR test for sexually transmitted infections

Abbott is pitching the assay as a way for healthcare providers to gain a fuller picture of a person’s health from a single test and create the optimal treatment plan.

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

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

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

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

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

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

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.

By Nick Paul Taylor • April 22, 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

FDA authorizes first COVID-19 breathalyzer test, clearing path to 3-minute results

After researchers began looking into ways to detect COVID-19 in breath samples, InspectIR Systems' test will be the first FDA-authorized breathalyzer. 

By Nick Paul Taylor • April 18, 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

With IVDR looming, EU prioritizes guidance on legacy devices and Eudamed transition

A staggered implementation of IVDR has left questions about how legacy tests put on the market will be regulated, and how information will be exchanged until the Eudamed medical device database is fully functional. 

By Nick Paul Taylor • April 13, 2022

Majority of diagnostic companies still implementing IVDR as deadline nears: survey

Eighty-five percent of respondents said they are implementing the new requirements, finds a survey from Climedo Health and TRIGA-S Scientific Solutions. But most are either familiar or very familiar with the regulations.

By Ricky Zipp • 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

'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