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

Explore the Trendline➔

New medical devices are reshaping the medtech industry

From pulsed field ablation devices to glucose sensors and surgical robotics, new medical technologies are transforming patient care and how people manage their health.

By MedTech Dive staff

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

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

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

FDA asks Congress for 14% bump in device budget for supply chain, cybersecurity programs

For the devices program, the FDA is asking for roughly $698 million, with approximately $466 million from the budget authority and $232 million from user fees.

By Nick Paul Taylor • March 29, 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

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

FDA urges COVID-19 test makers with EUAs to seek full authorizations

Tim Stenzel, head of the Office of In Vitro Diagnostics and Radiological Health, told developers it's time to "get in line" for premarket review to ensure products can be marketed beyond the public health emergency.

By Greg Slabodkin • March 24, 2022

Dexcom's hospital glucose monitor leads latest FDA breakthrough designations

The regulatory privileges were granted to Dexcom after its at-home glucose monitors were allowed to be used in hospitals during the pandemic. AltPep, CardioStory, Insightec and Merit were also among the designations this month.

By Nick Paul Taylor • 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

Illumina sues Guardant CEOs over trade secrets, sparking counterblast against 'retaliatory' lawsuit

Guardant called the lawsuit "frivolous and retaliatory" and framed it as a response to its concerns about the Illumina-Grail merger.

By Nick Paul Taylor • March 18, 2022