MDUFA V talks kick off as FDA grapples with onslaught of COVID-19 submissions

Medtech industry groups broadly expressed a desire to maintain the status quo after FDA Commissioner Stephen Hahn described the strain on agency workers under MDUFA IV as unsustainable.  

By Maria Rachal • Oct. 28, 2020

USPSTF proposes lowering colorectal cancer screening age in boost to Exact Sciences' Cologuard

A federal task force, which has recommended the stool-based kit, now advises screening starting at age 45 after modeling found the change would avert one additional death per 1,000 adults.

By Nick Paul Taylor • Oct. 28, 2020

Explore the Trendline➔

Top 5 stories from MedTech Dive

From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.

By MedTech Dive staff

LabCorp sees Q3 revenue rise 33%, but doesn't follow Quest in upping guidance

CEO Adam Schechter said the testing giant is following its rival in returning CARES Act funds, given the spike in COVID-19 testing revenues and return of routine screenings.

By Greg Slabodkin • Oct. 27, 2020

Exact Sciences stock jumps on cancer detection deals for Thrive, Base Genomics

The cancer diagnostics company is aiming to bolster its technology pipeline weeks after Illumina put up $8 billion to acquire liquid biopsy developer Grail.

By Nick Paul Taylor , Maria Rachal • Updated Oct. 27, 2020

EU notified body designation pipeline points to IVDR bottleneck

An update from the European Commission reveals only a few notified bodies are likely to join the four already designated over the coming months.

By Nick Paul Taylor • Oct. 26, 2020

Medtech Q3 results signal diagnostics boom, mixed bag on device growth

Hologic, BD and Zimmer Biomet are among the medtechs set to add to the growing mass of late summer data points this week.

Updated Nov. 2, 2020

Neuromod devices at the fore in latest FDA breakthrough designations

Liquid biopsies also stand out as an area where U.S. regulators are encouraging development and prioritizing review.

By Nick Paul Taylor • Oct. 23, 2020

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

CMS coverage draft shuns 1st-to-market colorectal cancer blood test, outlines path for Exact, Guardant

The proposed Medicare coverage memo rejected Epigenomics' bid for payment, but Wall Street said the bar set was clearable by potential rival liquid biopsy developers working on similar products.  

By Maria Rachal • Oct. 20, 2020

Robotic surgery startups help drive Q3 medical device funding over $5B, an all-time high

CB Insights also listed the progress of neuromodulation devices and Medtronic's deals in diabetes and neurosurgery as other highlights.

By Nick Paul Taylor • Oct. 20, 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

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-backed Cue gets $481M to onshore production of rapid COVID-19 test kit

The startup will use the government funding to scale production to 100,000 COVID-19 test kits a day at its San Diego facilities.

By Nick Paul Taylor • Oct. 14, 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

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

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