Remote trials, US-Israel device partnership among pitches in FDA, HHS funding bills

The Senate appropriations committee released a series of budget proposals for fiscal 2021. FDA's device center is slated for a 5% funding increase, making it one of the only centers set to receive less than requested.

By Nick Paul Taylor • Nov. 11, 2020

UK fleshes out post-Brexit approach to regional medical device marking

The Medicines and Healthcare products Regulatory Agency further clarified conformity marking as medtechs prepare for the transition period to end.

By Nick Paul Taylor • Nov. 11, 2020

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Medical device industry continues to turn to AI

While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.

By MedTech Dive staff

Abbott COVID-19 tests at center of squabble between Trump administration, states

HHS testing czar Brett Giroir on Monday said the government is halting the antigen test shipments to eight states until those already sent are distributed and used. At least one state pushed back on his assertions.

By Greg Slabodkin • Nov. 10, 2020

Quidel, Hologic, other test stocks sink as vaccine result brings hope for pandemic's end

The declines Monday, led by a 28% drop at Quidel, reflect concerns that availability of an effective COVID-19 vaccine will tamp down on the multibillion-dollar testing boom.

By Nick Paul Taylor • Nov. 10, 2020

What Intuitive is looking for through its new $100M venture fund

Surgical robots have been Intuitive's sweet spot. As the company moves into VC for the first time, its broader focus on minimally invasive care, including interest in digital tools and precision diagnostics, opens more opportunities.

By Maria Rachal • Nov. 9, 2020

Biden transition team names COVID-19 advisers, seeks dramatic testing scale-up with federal approach

The president-elect calls for doubling drive-through test sites and increasing capacity by "orders of magnitude" through investing in rapid at-home tests. The transition team has already called in help from former FDA and BARDA heads.

By Greg Slabodkin • Nov. 9, 2020

GenScript wins 1st FDA nod to test for antibodies that could neutralize COVID-19

The Hong Kong-listed biotech's offering differs from earlier EUAs for serology tests from Abbott, Roche and Siemens Healthineers that only screen for antibodies that do not necessarily cut viral infection.

By Susan Kelly • Nov. 9, 2020

Guardant beats expectations but warns COVID-19 surges will hurt Q4 growth

On a more optimistic note, the blood test developer expects the recent FDA approval for its Guardant360 tumor profiling liquid biopsy will increase its CMS payment rate and expand reimbursement among private payers.

By Nick Paul Taylor • Nov. 6, 2020

Patients shirked diagnostic testing, in-person preventive care amid telehealth boom this spring

Routine preventive services that can't be done virtually, such as mammograms and colonoscopies, plunged 65% in March and April compared to the year prior, according to an analysis published in JAMA Network Open.

By Hailey Mensik • Nov. 5, 2020

Even if Biden wins, divided Congress stifles chance for more progressive health policies

Results of the election are not final and may be uncertain for weeks, but the most likely scenario points to mostly incremental change, a positive for many parts of the healthcare sector.

By Shannon Muchmore • Nov. 5, 2020

BD returns to growth on COVID-19 antigen tests, but predicts price erosion

The company said sales related to its rapid testing could hit $1.5 billion next year, with the prospect of demand continuing into 2022. However, management thinks Abbott's $5 test could drive down its pricing.

By Nick Paul Taylor • Nov. 5, 2020

Hologic bets on COVID-19 molecular test boon beyond 2021

CEO Stephen MacMillan told investors he expects hospitals to screen all patients coming in for procedures for at least the next couple of years. "We believe, and we've made the bet, that there is a longer tail." 

By Nick Paul Taylor • Nov. 5, 2020

FDA warns of COVID-19 antigen test false positives as report flags Quidel on accuracy

The agency alert, prompted by reports from nursing homes and other settings, comes a day after data emerged raising concerns about the ability of a Quidel test to detect asymptomatic cases.

By Nick Paul Taylor • Nov. 4, 2020

Gauss says at-home COVID-19 antigen test comparable to PCR in clinical study

The company has yet to apply for FDA emergency use authorization after a 159-participant study. Such tests may "hold immense power," said Harvard epidemiologist Michael Mina, also warning EUAs are "not exactly a high bar."  

By Greg Slabodkin • Nov. 2, 2020

Siemens Healthineers projects up to 8% revenue growth in FY2021

The German imaging and diagnostics giant said it won U.S. antitrust approval for its planned $16.4 billion buyout of radiation oncology specialist Varian in late October, helping the deal close in the first half of 2021.

By Maria Rachal • Nov. 2, 2020

Hologic wins $119M from HHS, DOD to help double COVID-19 test production

The medtech will make 13 million diagnostics a month in the U.S. by January 2022. Separately, InBios International scored $12.7 million to expand rapid point-of-care antigen and antibody test manufacturing.

By Nick Paul Taylor • Nov. 2, 2020

Quidel Q3 revenue soars 276% as COVID-19 tailwinds forecast into 2022

CEO Doug Bryant told investors the company is ramping up test production in anticipation of the convergence of flu season with the ongoing pandemic.

By Greg Slabodkin • Oct. 30, 2020

Illumina defends Grail valuation amid much cheaper Exact-Thrive deal

The biotech defended its $8 billion purchase price against Exact Sciences' $2.15 billion cancer screening takeout agreement announced this week, arguing Grail has more data and is likely to be first to market.

By Nick Paul Taylor • Oct. 30, 2020

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

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