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

Explore the Trendline➔

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

Neovasc refractory angina treatment faces FDA panel review

The agency's ultimate approval decision on the Canadian company's CE-marked device has important financial implications for the medtech, which saw its revenue plunge and operating loss deepen in the second quarter.

By Susan Kelly • Oct. 27, 2020

FDA grants 510(k) to Abiomed's artificial lung, teeing up use in COVID-19

While LivaNova and Medtronic already sell ECMO devices, Abiomed is focusing on a relatively compact design to differentiate the device from the pack.

By Nick Paul Taylor • Oct. 27, 2020

FDA, Philips warn of data bias in AI, machine learning devices

The comments come 18 months after FDA unveiled a yet-to-be-finalized framework for modifying AI/ML-based software as a medical device using real-world learning and adaptation.

By Greg Slabodkin • Oct. 26, 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

HHS walks back CARES fund reporting requirement hospitals feared

Health systems worried they may lose COVID-19 relief money after guidance changed last month. Those funds have been crucial in mitigating big hits to capital spending, execs at medtechs like BD and Stryker have said.

By Samantha Liss • Oct. 23, 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

FDA floats framework to message cybersecurity threats to patients

The proposal, which has the agency and industry sharing responsibility for making the information easy to find, comes as the risks to medical devices continue to grow.

By Nick Paul Taylor • Oct. 21, 2020

AdvaMed seeks regulatory clarity on FDA's new digital health center

Director Bakul Patel says the new unit aims to provide the "least burdensome" oversight and that evidence will be key, but industry says medtechs still have questions on what rules they're subject to.

By Greg Slabodkin • Oct. 20, 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

Future of COVID-19 products, device shortages, CDS top CDRH 2021 to-do list

Regulators aim to publish final guidance on five topics and draft documents on another dozen priority areas in the coming year. A few of the goals are carryovers as priorities shifted during the public health emergency.

By Susan Kelly • Oct. 19, 2020

CMS expands Medicare emergency telehealth coverage with 11 new services

For the first time in five months, the agency made new virtual care additions including electronic analysis of an implanted neurostimulator pulse generator and intensive cardiac rehab with or without continuous EKG monitoring.

By Rebecca Pifer • Oct. 16, 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

FDA finalizes guidance on nitinol devices, posts biocompatibility draft

The agency has been looking at the alloy, commonly used in stents and heart valves, as part of a broader look at metals that can cause inflammatory or other types of reactions once inside the body.

By Nick Paul Taylor • Oct. 15, 2020

De Novo-winning devices often lack effectiveness data, analysis shows

A JAMA Internal Medicine analysis of 63 devices reviewed via FDA's premarket pathway for novel technologies found one-fifth weren't evaluated in pivotal studies.

By Nick Paul Taylor • Oct. 13, 2020

FDA takes hands off EUA review for COVID-19 lab developed tests

The move follows the administration in August no longer requiring premarket review for LDTs, letting labs voluntarily seek emergency use nods. A lab trade group said the latest decision creates "unnecessary confusion."

By Greg Slabodkin • Oct. 8, 2020

'Tragedy' if FDA doesn't extend COVID-19 lessons beyond pandemic, Shuren says

Device head Jeff Shuren acknowledged the regulatory paradigm for medical devices is more than 40 years old and "not well suited for many modern-day technologies," speaking at AdvaMed's Virtual MedTech Conference.

By Greg Slabodkin • Oct. 7, 2020

Medical Alley, GI docs push to ease CMS device pass-through payments

The trade group for Medtronic, Boston Scientific and other medtech giants wants to bar Medicare contractors from making regional coverage decisions that obstruct transitional pass-through payments.

By Susan Kelly , Maria Rachal • Oct. 6, 2020

CMS officials elaborate on proposed breakthrough device coverage pathway

Agency representatives fleshed out details of proposed reimbursement meant to speed coverage of these technologies in a townhall webcast during AdvaMed's Virtual MedTech Conference.

By Susan Kelly • Oct. 6, 2020

AdvaMed sends CMS reform wishlist to boost digital health device coverage

The medtech industry group argues changes are needed for Medicare to realize the potential of a sector projected to be worth $500 billion by 2026.

By Nick Paul Taylor • Oct. 2, 2020

5 ways COVID-19 is reshaping the medtech industry

Remote tech, clinical trials and marketing are a few of the areas disrupted by the pandemic this year — with changes that look set to stick around.

By Maria Rachal , Greg Slabodkin • Oct. 1, 2020

Medtronic hit with DOJ ventilator antitrust probe

The investigation comes amid allegations that industry consolidation contributed to a shortage of the breathing devices during the early months of the COVID-19 pandemic.   

By Greg Slabodkin • Oct. 1, 2020

FDA flags risk of infection with CardioQuip heater-cooler device

The alert comes after three patients were infected with mycobacteria. All such devices on the U.S. market have now been implicated in contamination, including those made by LivaNova, Cincinnati Sub-Zero, Maquet and Terumo.

By Nick Paul Taylor • Updated Oct. 1, 2020

FDA finalizes black box warning for breast implants

The term "breast implant illness," which one industry group decried as not used in clinical practice, appears multiple times throughout the agency's document but not in its example boxed warning.

By Susan Kelly • Updated Sept. 29, 2020