FDA tracks uptick in masks, other protective gear in coronavirus update

Commissioner Stephen Hahn said the shift in ordering patterns is yet to manifest in a shortage but warned Friday the situation is “evolving and very dynamic.”

By Nick Paul Taylor • Feb. 18, 2020

LabCorp weathers rising personnel costs to beat expectations in Q4

Quest Diagnostics said the trend is an emerging source of pressure, while LabCorp had a more tempered reaction.

By Nick Paul Taylor • Feb. 13, 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

Exact Sciences beefs up sales force as it seeks big Cologuard growth in 2020

The cancer diagnostics company said fresh TV ads and physicians' increasing ability to place orders through an updated version of Epic will spur sales of its colorectal cancer test.

By Nick Paul Taylor • Updated March 3, 2020

Snapshot: How medtech earnings season is shaping up

Most medtechs offered financial outlooks for 2020 over the last month, but the novel coronavirus could have a longer impact than originally factored in.  

By Maria Rachal • Updated March 6, 2020

Longtime Myriad CEO resigns amid another steep earnings miss, guidance cut

Sales in the prenatal and hereditary cancer divisions, plus the seemingly promising GeneSight line, all declined during the quarter.

By Nick Paul Taylor • Feb. 7, 2020

Qiagen, still independent, limps back from 2019

The Dutch maker of infectious disease instruments and consumables is seeking a rebound, with an early boost from coronavirus-driven demand. Cowen analysts noted the firm beat expectations but added: "The bar was quite low."

By Nick Paul Taylor • Feb. 5, 2020

Emergency use coronavirus tests shows glitches at state level, CDC says

CDC officials said Wednesday that some of the test kits it distributed to states produced inconclusive results when tested independently. The agency noted the tests were not run on patients.

By Maria Rachal • Updated Feb. 13, 2020

Brexit happened. EU MDR looms. 3 key questions on medtech's future in Europe

The U.K. can skip the new in vitro diagnostic rules entirely, and in theory, could unilaterally stop applying MDR after the transition period ends. Both scenarios seem unlikely.

By Nick Paul Taylor • Feb. 4, 2020

Medtech in limbo as Brexit arrives

Although the industry has lobbied for the departing member state to implement the Medical Device Regulation and stick closely to EU rules, a minister in the U.K. government said legislative alignment “just ain't happening.”

By Nick Paul Taylor • Feb. 3, 2020

Amid coronavirus outbreak, FDA and industry seek roadmap for emergency diagnostics

Taking lessons from the Ebola and Zika crises, regulators and manufacturers are meeting Monday to discuss how real-world data could be used to advance more emergency-use diagnostics to full marketing status.

By Maria Rachal • Updated Jan. 31, 2020

UK moves to mitigate impact of notified body withdrawals

Several firms pulled their services amid uncertainty about the impact of Brexit, bringing risks into focus.

By Nick Paul Taylor • Jan. 30, 2020

CMS widens NGS test coverage for inherited breast, ovarian cancers

The national decision on next generation sequencing tests doesn't go beyond breast and ovarian cancers, but local Medicare contractors are allowed discretion on coverage determinations with other germline cancer diagnoses.

By Maria Rachal • Jan. 28, 2020

Natera takes ArcherDX to court over cancer testing patent

Genetic testing company Natera claims it has exclusive rights to use multiplex PCR in certain cancer settings.

By Nick Paul Taylor • Jan. 28, 2020

CDC urgently working to make coronavirus lab diagnostic available

A Centers for Disease Control and Prevention official told reporters the agency is in the process of growing the virus for further study and working to get laboratory diagnostics to state and local health departments.

By Shannon Muchmore • Jan. 27, 2020

3 more notified bodies coming soon, EC says as MDR clock ticks down

New designations would move the Commission a step closer to its goal of having 20 notified bodies in place by the end of the first quarter of 2020.

By Nick Paul Taylor • Jan. 23, 2020

Abbott ups 2020 growth targets, downplays Libre 2 delay

After exceeding the high end of its 2019 sales forecast on success in electrophysiology, heart failure, structural heart and diabetes, the company forecasts up to an 8% rise in organic growth this year.

By Maria Rachal • Jan. 22, 2020

ArcherDX, Geneoscopy, Phagenesis win breakthrough device designations

A cancer relapse test, a colorectal cancer screening test and a device to restore swallowing control are among the latest technologies to benefit from certain regulatory perks.

By Nick Paul Taylor • Jan. 15, 2020

LabCorp, Quest push for M&A-driven growth despite difficulties closing deals

“It’s still a very fragmented marketplace,” said Quest CEO Steve Rusckowski at JPM. "Trying to get people to move fast has been harder than I would have anticipated,” LabCorp's new CEO Adam Schechter told investors.

By Nick Paul Taylor • Jan. 15, 2020

Nevro, NuVasive, Integra, others preview earnings at JPM

Wednesday's lineup of medtech presenters includes Exact Sciences, Intersect ENT, ICU Medical and handheld ultrasound device maker Butterfly.

By Maria Rachal • Updated Jan. 15, 2020

Adaptive gets CMS coverage for chronic lymphocytic leukemia test

The expanded Medicare policy covers use of the assay in the monitoring of minimal residual disease.

By Nick Paul Taylor • Jan. 9, 2020

CMS delays clinical lab fee schedule data reporting, cuts capped at 15% for 2021

The decision to maintain the status quo comes despite labs hoping the agency would freeze rate cuts next year.

By David Lim • Jan. 3, 2020

Illumina scraps $1.2B PacBio takeover amid regulatory pushback

Cowen analysts listed Agilent, Danaher and Thermo Fisher as potential buyers of Pacific Biosciences.

By Nick Paul Taylor • Jan. 3, 2020

Notified bodies MedCert, BSI gain new EU MDR and IVDR designations

The European Commission's latest nods bring total notified bodies designated for the Medical Device Regulation to nine and for the In Vitro Diagnostic Regulation to three.

By Nick Paul Taylor • Dec. 31, 2019

Myriad wins FDA nod for Lynparza companion diagnostic

The test is meant to identify metastatic pancreatic cancer patients with a germline BRCA mutation who are candidates for AstraZeneca and Merck's pill, the second targeted treatment approved for pancreatic cancer.

By Jonathan Gardner • Dec. 30, 2019

FTC seeks to block Illumina's $1.2B PacBio acquisition over monopoly concerns

Illumina announced Wednesday it will extend the end time of its merger plan with PacBio to March 31, 2020.

By David Lim • Updated Dec. 19, 2019