iHealth Lab gets DoD order for additional 104M home COVID-19 tests

The transaction brings the total number of kits the Department of Defense has ordered from iHealth Lab to more than 350 million, putting the company at the heart of the Biden administration's effort to boost testing capacity.

By Nick Paul Taylor • Jan. 31, 2022

Abbott Q4 revenue beats estimates on demand for COVID-19 tests; company warns of 2022 uncertainty

Abbott provided an initial coronavirus test sales forecast of $2.5 billion, which is expected to occur early in the year and will be updated quarterly. Evercore ISI analysts said the company's "testing assumptions seem derisked."

By Greg Slabodkin • Jan. 26, 2022

FDA finalizes two guidances on including patient perspectives in medtech clinical trials

The documents, which elaborate on how to engage patients to improve trial design and use patient-reported outcomes, are based on feedback from groups like AdvaMed which raised concerns about "significant" legal issues.

By Nick Paul Taylor • Jan. 26, 2022

GE Healthcare's revenue hit by continued supply chain challenges

GE CEO Larry Culp said Tuesday that ongoing supply chain disruptions were "most acute" in healthcare and will last through at least the first half of 2022, describing the persistent problem as the worst in decades.

By Greg Slabodkin • Jan. 25, 2022

Medtech earnings season shows bumpy end to 2021 for some, bonanza for others

Procedure-dependent companies were negatively impacted to a greater or lesser degree by the surge in omicron cases in their most recent quarters, while COVID-19 test makers benefitted from the spike in demand.

By Elise Reuter • Jan. 24, 2022

Philips targets Q4 2022 end to recall as supply chain issues drag down results

The recall, which now impacts 5.2 million sleep apnea and ventilator machines, contributed to a 10% fall in comparable sales in the fourth quarter of 2021, while the increase in affected devices led Philips to up its field action provision.

By Nick Paul Taylor • Jan. 24, 2022

Diagnostics makers ride omicron surge in COVID-19 test demand. But for how long in 2022?

The highly transmissible variant caused the Biden administration to announce plans to buy 1 billion rapid tests to provide free to Americans. However, when testing will ramp back down remains an open question.  

By Greg Slabodkin • Jan. 20, 2022

Exact Sciences posts positive data on Cologuard 2.0 ahead of readouts on rival tests

A study found Exact's second-generation stool test has a lower false positive rate than the current product and is better at detecting precancerous lesions. But it is facing competing blood tests from Freenome and Guardant Health.

By Nick Paul Taylor • Jan. 20, 2022

FDA misses MDUFA V deadline after months of contentious talks

The agency has failed to send the final MDUFA V user fee agreement to Congress by the Jan. 15 deadline, suggesting there may be unresolved disagreements with industry over elements of the program.

By Nick Paul Taylor • Jan. 19, 2022

Abbott, BD, Quidel pursue DTC strategies amid 'paradigm shift' for at-home, self-testing

The three test makers said at last week's J.P. Morgan healthcare conference that they see opportunities for direct-to-consumer, digitally-connected testing for other diseases beyond COVID-19.

By Greg Slabodkin • Jan. 18, 2022

Biden administration to buy 500M more rapid COVID-19 tests to give to Americans

The announcement by President Joe Biden now brings the administration's total purchase to 1 billion test kits. Abbott Laboratories, iHealth and Roche have so far been awarded contracts for a combined 380 million tests.

By Greg Slabodkin • Jan. 14, 2022

Medtech M&A, IPOs hit new highs as more buyers enter the space: SVB

In a new report, Silicon Valley Bank projects that medical device mergers and acquisitions "will stay hot, as a diverse set of acquirers compete for the top deals," but sees a slowdown in initial public offering activity.

By Nick Paul Taylor • Jan. 14, 2022

Neurological devices, diagnostics dominate latest FDA breakthrough designations

The agency has granted breakthrough designations to several devices for neurological conditions, including an autism test and treatment as well as diagnosis of Parkinson's disease.

By Nick Paul Taylor • Jan. 13, 2022

Notified body shortage remains pressing as industry prepares for staggered IVDR rollout

Three months have passed since the European Commission warned about a "grave shortage of notified body capacity," but the situation is largely unchanged.

By Nick Paul Taylor • Jan. 13, 2022

Biden health officials defend COVID-19 testing policies amid diagnostics shortage

Acting FDA Commissioner Janet Woodcock and others were under fire from senators during a Tuesday hearing for not doing enough to increase the availability of tests.   

By Greg Slabodkin • Jan. 12, 2022

Insurers will be required to cover 8 at-home COVID-19 tests per month

After proposing the plan in December, the Biden administration on Monday detailed its plan to have insurers cover rapid tests. Health insurance lobby AHIP warned of potential "hiccups in early days" of implementation.

By Nick Paul Taylor • Jan. 11, 2022

Hologic tops guidance as COVID-19 testing wave delivers another beat

The test maker said it will comfortably beat first-quarter guidance, with demand for coronavirus diagnostics helping the company post preliminary revenues of almost $1.5 billion. Quidel set the tone last week with its own beat. 

By Nick Paul Taylor • Jan. 10, 2022

Quidel preliminary Q4 revenue beats Street on COVID-19 test sales

Fourth-quarter revenue was more than 35% above the consensus analyst estimate, though it was still down from Quidel's 2020 strong final quarter.

By Nick Paul Taylor • Jan. 7, 2022

Abbott, Quidel COVID-19 antigen tests found to lag PCR in detection of omicron

A small real-world study, which has yet to be peer reviewed, found the rapid tests may fail to detect some omicron cases during the first days of infection.

By Nick Paul Taylor • Jan. 6, 2022

Quest's COVID-19 test results turnaround hits longest wait since 2020

The lab giant is taking an average of two to three days to deliver results for molecular diagnostic tests amid the omicron surge, compared to the one-day turnaround time it achieved throughout most of 2021.

By Nick Paul Taylor • Jan. 6, 2022

Medtechs brace for hit as hospitals warn of omicron impact on surgeries

Healthcare staff shortages and rising COVID-19 admissions are forcing hospitals to cancel elective surgeries and postpone diagnostic and imaging procedures. BTIG sees as much as a 7% revenue hit for exposed companies.

By Nick Paul Taylor • Jan. 5, 2022

Medtech's biggest deals in 2021 and what to expect next

After dealmaking took off last year following a 2020 lull, market watchers anticipate robust M&A ahead in 2022 as companies pursue faster growth and greater scale. 

By Susan Kelly • Jan. 4, 2022

Roche, Siemens at-home tests get EUAs as US faces COVID-19 testing shortage

FDA granted emergency use authorizations to the over-the-counter diagnostics under a new accelerated review program. However, the companies may need months to scale up production.

By Nick Paul Taylor • Jan. 4, 2022

Quidel to buy Ortho Clinical Diagnostics in $6B deal; stock tanks

CEO Doug Bryant said the combined company will have a "broader geographic footprint" thanks to Ortho's reach across 130-plus countries. Quidel's shares fell by as much as 17.8% in Thursday morning trading.

By Greg Slabodkin • Dec. 23, 2021

FDA seeks feedback on 180-day notice period for termination of COVID-19 EUAs

The agency's plan is intended to avoid supply disruptions while moving back toward the regulatory requirements of routine operations.

By Nick Paul Taylor • Dec. 23, 2021