Diagnostics

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 5 hours ago

Explore the Trendline➔

COVID-19 diagnostics surge as industry prepares for spike in at-home testing

With strong demand once again for rapid at-home coronavirus tests, medtech companies are looking beyond COVID-19 to sell over-the-counter and direct-to-consumer diagnostics for other diseases. 

By MedTech Dive staff

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

Medtech sounds alarm on semiconductor shortages, asks feds to prioritize chips for medical use

AdvaMed and several device companies, including BD, Medtronic and Philips, have reiterated to the Biden administration how supply chain constraints are causing an "unsustainable" disruption to the industry.

By Nick Paul Taylor • Nov. 10, 2021

GE unveils plan to spin off healthcare business

The independent company, expected to be separated by early 2023, is being positioned as having more flexibility to pursue acquisitions as it sharpens its focus on precision health and struggles with supply chain shortages.

By Susan Kelly • Nov. 10, 2021

CMS repeals MCIT breakthrough device final rule, leaves open other coverage pathways

The agency on Friday officially rescinded the Medicare Coverage for Innovative Technologies rule due to safety concerns following strong opposition from some healthcare groups, despite strong support for the rule in the medtech industry.

By Nick Paul Taylor • Updated Nov. 12, 2021

Philips grows cardiac monitoring business with Cardiologs pickup

Nearly one year after announcing its $2.8 billion acquisition of BioTelemetry, the Dutch conglomerate is further expanding its reach in remote patient monitoring with the purchase of France-based Cardiologs.

By Susan Kelly • Nov. 9, 2021

CMS finalizes plans for pay cuts for radiation oncology, other specialists

Device makers could feel the pinch in cuts to services that use pricey equipment for vascular surgery, interventional radiology and diagnostic testing, which AdvaMed contends will decrease patient access to care.

By Shannon Muchmore • Nov. 3, 2021

Thermo Fisher, Hologic ride wave of COVID-19 test demand, for now

The two lateral flow assay companies reported strong coronavirus testing sales in the latest quarter. However, Hologic CFO Karleen Oberton told investors late Monday the pandemic remains unpredictable.

By Greg Slabodkin • Nov. 2, 2021

Siemens' Varian leads latest FDA breakthrough device designations

Varian secured the regulatory privileges for its noninvasive treatment of knee osteoarthritis based on technology acquired from Boston Scientific. Magnus Medical, Renovia and MY01 are included in the latest batch of designations.

By Nick Paul Taylor • Nov. 1, 2021

FDA, global peers create guiding principles for AI/ML medical devices

The U.S., U.K. and Canada are seeking international harmonization as part of a broader discussion on the development of safe, effective devices that use artificial intelligence and machine learning.

By Nick Paul Taylor • Oct. 29, 2021

FDA's 2022 A-list guidance plan hits on software, post-pandemic future

The agency's priorities include a much-anticipated final guidance on clinical decision support software — more than five years in the making — meant to clarify when CDS meets the definition of a medical device.

By Nick Paul Taylor • Oct. 27, 2021

Notified bodies join chorus of criticism of proposed European AI regs

Team-NB has come out strongly against the regulation, arguing it will add to administrative burdens, reduce notified body capacity and create confusion.

By Nick Paul Taylor • Oct. 26, 2021