EU finalizes staggered rollout of IVDR, removing near-term threat to diagnostic supply

MedTech Europe welcomed the adoption of the amended transitional provisions, which it said mitigate "the immediate and urgent risk" of disruption.

By Nick Paul Taylor • Dec. 21, 2021

Roundup: Omicron variant's impact on COVID-19 tests

As the variant of concern continues to spread worldwide, FDA and test makers have scrambled to assess whether the performance of diagnostics are affected by omicron's viral mutations. Here's what we know so far.  

Updated Dec. 29, 2021

FDA in update says 2 COVID-19 tests fail to detect the omicron variant

Diagnostics from Applied DNA Sciences and Meridian Bioscience are not able to detect omicron, causing false negative results, according to the agency, while Tide Laboratories has fixed the problem with its test.

By Greg Slabodkin • Updated Dec. 29, 2021

3 medtech markets poised to thrive in 2022 despite renewed COVID-19 pressures

While the emergence of the omicron variant is muddying next year's medtech outlook, analysts have identified three niches within the sector best positioned to successfully weather the continued strains on the healthcare system.

By Susan Kelly • Dec. 15, 2021

Senate passes bill to delay 2022 Medicare rate cuts for hundreds of lab tests

Senators late Thursday passed an end-of-year package that will delay the 15% cuts for nearly 600 tests slated to kick in next month. Passed by the House on Tuesday, the bill must still be signed by President Joe Biden to become law.

By Greg Slabodkin • Updated Dec. 10, 2021

Cancer treatments lead latest FDA breakthrough device designations

The agency granted regulatory privileges to therapies for lung cancer and bone metastases from RefleXion Medical and Zetagen Therapeutics, respectively.

By Nick Paul Taylor • Dec. 7, 2021

Thermo Fisher, Verily on FDA list of COVID-19 tests affected by omicron variant

The agency's list focuses on coronavirus diagnostics impacted by S-gene dropout, an occurrence that is most commonly associated with Thermo Fisher Scientific's TaqPath test kits.

By Nick Paul Taylor • Dec. 6, 2021

Congress passes on delay to Medicare rate cuts for lab tests, for now

The American Clinical Laboratory Association wants lawmakers to push off 2022 cuts for nearly 600 lab tests. A stopgap bill late last week did not include a reprieve, but Cowen analysts are optimistic a legislative fix will be found.

By Greg Slabodkin • Dec. 6, 2021

Biden orders private health insurers to cover COVID-19 home tests

Test makers such as Abbott, BD and Quidel could see demand increase as costs for consumers are reimbursable. The White House is also doubling distribution of free at-home tests to uninsured and underserved communities.

By Nick Paul Taylor • Dec. 3, 2021

FDA finds 'low likelihood' omicron will impact COVID-19 PCR, antigen tests

The agency joined the chorus of top testing manufacturers, including Abbott Laboratories, Quidel and Thermo Fisher Scientific, claiming that current coronavirus diagnostics can accurately identify the omicron variant.

By Nick Paul Taylor • Dec. 1, 2021

FDA updates eSTAR ahead of expanding filing template for De Novo submissions

The platform has been available for manufacturers to voluntarily submit 510(k) submissions since September 2020. The agency will start accepting De Novo applications when a final rule takes effect early next year.

By Nick Paul Taylor • Nov. 30, 2021

Abbott, BD join chorus of COVID-19 test makers claiming diagnostics not impacted by omicron variant

Becton Dickinson on Tuesday became the latest testing manufacturer to express confidence that both its rapid antigen and PCR tests will detect the variant, which the World Health Organization says poses a "very high" risk.   

By Greg Slabodkin • Updated Nov. 30, 2021

BD test, others among rapid antigen kits authorized for one-time use by FDA

The agency has authorized another three over-the-counter COVID-19 antigen home tests for single use in people with symptoms, furthering the emergence of the kits as an alternative to PCR.

By Nick Paul Taylor • Nov. 29, 2021

IVDR milestone as EU expert panel delivers first opinion on a diagnostic submission

The In Vitro Diagnostic Medical Devices Regulation panel, which got off to a rocky start earlier this year, provided a glowing assessment of a test by an undisclosed company that screens plasma donor samples for hepatitis E virus.

By Nick Paul Taylor • Nov. 29, 2021

Roundup: COVID-19 surge, hospital labor shortages, supply chain issues hit medtechs in latest earnings

After the industry began recovering in the first half of the year, top companies reported that the delta variant surge put a drag on businesses last quarter.

Nov. 23, 2021

CMS proposes smokers begin lung cancer screening at age 50 instead of 55

The agency is revisiting its national coverage determination to catch the disease at an earlier stage. Needham analysts say a larger pool of patients will drive demand for test makers Veracyte, Oncocyte and NeoGenomics.

By Susan Kelly • Nov. 22, 2021

Latest breakthrough device designations go to brain-computer interface, exo-suit

Regulatory privileges were awarded to Blackrock Neurotech's brain-computer interface, designed to assist immobile patients with performing activities, and ReWalk Robotics' exo-suit, which is intended to help stroke patients walk. 

By Nick Paul Taylor • Nov. 22, 2021

FDA shakes up hepatitis C testing market by opening up 510(k) pathway

Lowering the barrier to the market could increase competition in spaces targeted by companies such as Abbott Laboratories and Roche. 

By Nick Paul Taylor • Nov. 22, 2021

New iRhythm CEO talks Medicare pricing, larger medtech competitors, international markets

"I think the near-term noise is something that we'll work through, but the underlying technology has never been questioned," Quentin Blackford told MedTech Dive.

By Ricky Zipp • Nov. 19, 2021

MCIT breakthrough device payment pathway included in Cures 2.0 bill

Lawmakers on Tuesday introduced a revised MCIT proposal in the next version of the 21st Century Cures Act, following last week's repeal of the final rule by CMS. Industry groups AdvaMed and MDMA both back the legislation.  

By Nick Paul Taylor • Nov. 17, 2021

Siemens Healthineers projects revenue jump fueled by Varian double-digit sales growth

The medtech expects its $16.4 billion Varian acquisition to post annual sales growth from 2023 to 2025, leading it to forecast accelerating revenue rises.

By Nick Paul Taylor • Nov. 17, 2021

FDA to regulate lab developed tests in policy reversal

HHS is withdrawing a Trump-era policy that exempted LDTs from premarket review. The American Clinical Laboratory Association warned continually shifting policies "undermines patient access to lifesaving diagnostics."

By Susan Kelly • Nov. 16, 2021

BD's $2B annual M&A war chest, connected care devices at heart of growth plan

Evercore ISI analysts said the targets and messaging were consistent with expectations, while J.P. Morgan questioned why it is taking BD longer than its peers to return margins to pre-pandemic levels.

By Nick Paul Taylor • Nov. 15, 2021

Biden nominates Robert Califf to return as FDA head

If confirmed, the cardiologist would return to lead an agency taxed by a heavy COVID-19 workload and a backlog of initiatives back-burnered amid the pandemic.

By Ned Pagliarulo , Jonathan Gardner • Updated Nov. 12, 2021

After another successful quarter, diabetes tech players look ahead to key product launches

Dexcom's new G7 CGM system is expected to gain CE mark clearance in Q4, and Insulet's Omnipod 5 insulin pump is on track for FDA clearance and a limited launch by the end of the year.

By Ricky Zipp • Nov. 11, 2021