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

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

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

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