Quest revenue jumps 43% on COVID-19 tests, hands back federal funds

Execs said they now have a "clearer line of sight" into base business and coronavirus testing trends, but both remain "swing factors." Still, the lab giant raised its 2020 outlook and is returning $138 million in CARES monies.

By Greg Slabodkin • Oct. 22, 2020

Abbott device growth returns as Wall Street queries staying power of COVID-19 test boom

CEO Robert Ford argued that focusing on how coronavirus test demand will evolve "misses the point," touting the longer-term benefits of its now-expanded diagnostic platforms footprint.

By Maria Rachal • Oct. 21, 2020

Thermo Fisher's coronavirus tailwinds swell, outpacing Q3 analyst estimates

Sales of PCR test kits, instrumentation and viral transport media are all growing quickly enough to offset declines in the price of personal protective equipment and ongoing pressures on immunodiagnostics and transplant diagnostics.

By Nick Paul Taylor • Oct. 21, 2020

FDA, medtechs envision new era for clinical trials amid COVID-19 shake-up

Medtronic, for example, has faced "very significant delays" in getting products approved as a result of research disruptions, the company's VP of global clinical affairs said during a discussion at TCT.

By Maria Rachal • Updated Oct. 20, 2020

Future of COVID-19 products, device shortages, CDS top CDRH 2021 to-do list

Regulators aim to publish final guidance on five topics and draft documents on another dozen priority areas in the coming year. A few of the goals are carryovers as priorities shifted during the public health emergency.

By Susan Kelly • Oct. 19, 2020

Philips Q3 connected care sales up 42%, but ventilators to decline next year

The company expects the COVID-19 tailwinds, including double-digit growth in patient monitors and ventilators, to extend through the fourth quarter but fall away in 2021.

By Greg Slabodkin • Oct. 19, 2020

CMS to cut COVID-19 test pay by 25% for delayed results, labs cry foul

The American Clinical Laboratory Association, which includes LabCorp and Quest, argued the new policy fails to address the root of delays: fluctuating demand and supply chain disruptions.

By Nick Paul Taylor • Oct. 16, 2020

Intuitive sees partial Q3 recovery but warns COVID-strained hospital finances continue

Between customers tightening their belts and having first-time competition on the horizon, the longtime robotic surgery leader is rethinking approaches to pricing and M&A.

By Nick Paul Taylor • Oct. 16, 2020

Roche diagnostics Q3 sales spiked 18% as COVID-19 offset routine test drop

Execs contend the momentum is sustainable even with arrival of a vaccine, citing government demand for high-throughput machinery and a shift in importance to antibody testing.

By Maria Rachal • Oct. 15, 2020

Qiagen beats sales forecast on COVID-19 growth, but leaves room for skeptics

Non-coronavirus revenue saw a mid-single-digit drop and sales of a key TB test fell 20%. While those metrics improved from earlier in the year, Cowen analysts said the slump gives ammunition to doubters.

By Nick Paul Taylor • Oct. 14, 2020

J&J US device unit returns to growth, potential bellwether for medtech Q3 earnings

A double-digit rise in interventional sales was offset by ongoing headwinds in parts of the orthopaedic and surgery franchises.

By Nick Paul Taylor • Oct. 13, 2020

Cancer testing drives 2020 medtech IPO surge after slow start

A flurry of activity began in June, including from China-based Burning Rock and Genetron and U.S.-based Progenity.

By Nick Paul Taylor • Oct. 12, 2020

5 key exec insights from 2020's MedTech Conference

Top leaders from Abbott, BD, Medtronic, Stryker and Zimmer Biomet shared the latest on the industry's recovery during the pandemic and thoughts on where it goes from here.

By Maria Rachal • Oct. 9, 2020

Roche, Abbott, LDTs are most used COVID-19 tests as supply chain constraints force labs to diversify

Shortages of test kits and other supplies persist, according to the labs polled by the Association for Molecular Pathology.

By Nick Paul Taylor • Oct. 9, 2020

Fresenius sees COVID-19 driving dialysis device growth, eyes home care strategy

Execs at the company, which upped production of machines by 230% in response to the crisis, laid out plans at an investor day Thursday.

By Nick Paul Taylor • Oct. 9, 2020

FDA takes hands off EUA review for COVID-19 lab developed tests

The move follows the administration in August no longer requiring premarket review for LDTs, letting labs voluntarily seek emergency use nods. A lab trade group said the latest decision creates "unnecessary confusion."

By Greg Slabodkin • Oct. 8, 2020

Abbott, on defense, details embattled rapid COVID-19 test results

New data on the ID Now product comes amid criticism that the White House leaned too heavily on the quick-turnaround diagnostic, in light of President Donald Trump's illness and widespread West Wing infection.

By Nick Paul Taylor • Oct. 7, 2020

'Tragedy' if FDA doesn't extend COVID-19 lessons beyond pandemic, Shuren says

Device head Jeff Shuren acknowledged the regulatory paradigm for medical devices is more than 40 years old and "not well suited for many modern-day technologies," speaking at AdvaMed's Virtual MedTech Conference.

By Greg Slabodkin • Oct. 7, 2020

Amid pandemic, specialty telehealth outpaces urgent care, Amwell poll says

Willingness to use virtual care notably doubled in a handful of high-volume fields like radiology, cardiology and surgery, the survey found.

By Rebecca Pifer • Oct. 6, 2020

M&A on horizon as deep-pocketed medtechs eye distressed assets: EY

The combination of smaller companies questioning their pandemic survival and larger companies with considerable capital may spark a buying surge, the consultancy said in its annual medtech report.

By Nick Paul Taylor • Oct. 6, 2020

Ex-FDA chief Gottlieb questions White House reliance on Abbott COVID-19 test amid Trump diagnosis

"The Cepheid GeneXpert probably would be more fit to purpose. But, frankly, you'd need double layers of testing," President Donald Trump's former agency head said in a television appearance Sunday.

By Greg Slabodkin • Oct. 5, 2020

Quidel antigen test to detect COVID-19 and flu gets FDA nod

While Roche, Cepheid and LabCorp are among the companies offering combination tests, Quidel is the first to sell a fast-turnaround antigen-based option.

By Nick Paul Taylor • Oct. 5, 2020

AdvaMed sends CMS reform wishlist to boost digital health device coverage

The medtech industry group argues changes are needed for Medicare to realize the potential of a sector projected to be worth $500 billion by 2026.

By Nick Paul Taylor • Oct. 2, 2020

Smith & Nephew, Quidel forecasts may signal improving ortho, diagnostics markets

The preliminary Q3 results are a positive sign for elective surgery volumes at other orthopaedics competitors such as J&J and Stryker and for COVID-19 antigen testing businesses including Abbott and BD.

By Nick Paul Taylor • Oct. 2, 2020

Ethylene oxide sterilizer rule pushed back by EPA

FDA held a related advisory panel late last year, where one member said the shutdown of device sterilization plants put the U.S. "on the cusp of a major medical logistical failure." COVID-19 has shifted the landscape.

By Maria Rachal • Oct. 1, 2020