FDA's 1st full OK to BioFire's COVID-19 test clears shorter path for others

Full agency approval of the diagnostic, now permitted to be marketed beyond the public health emergency, lets other companies secure non-emergency authorizations through a 510(k).

By Nick Paul Taylor • March 19, 2021

Abbott awarded $255M federal contract for rapid COVID-19 antigen tests

The company will initially provide 50 million of its point-of-care diagnostics to HHS for use in Florida and Maine, with the potential for up to $766 million under the eight-month deal.  

By Greg Slabodkin • March 18, 2021

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

From labs to homes: where COVID-19 testing is headed in 2021

The U.S. appears to have reached a new phase in its battle against the coronavirus with vaccinations taking precedence over tests. Whether testing will return to earlier levels is an open question.

By Greg Slabodkin • March 17, 2021

FDA backs home use of COVID-19 tests without data in asymptomatic people

The move could benefit companies like Quidel, which aims to market an over-the-counter antigen test but has been held up by the need for more data on those without symptoms.   

By Nick Paul Taylor • March 17, 2021

FDA touts real-world evidence use by Abbott, Medtronic in analysis of regulatory decisions

The agency has released details of how medtechs have used RWE, such as registries and medical records, to support filings including 510(k) submissions and premarket approval applications.

By Nick Paul Taylor • March 17, 2021

CMS puts the brakes on breakthrough device coverage rule

The policy would automatically OK Medicare reimbursement for devices with FDA breakthrough status, but critics contend the rule would undermine CMS authority to consider the clinical evidence backing new technologies.

By Susan Kelly • March 16, 2021

FDA flags risk of device fracture in Colfax's STAR ankle replacements

The products, recently divested to Colfax from Stryker, showed fractures occurring as early as three to four years after implant in an FDA analysis of post-approval study data and adverse event reports.

By Susan Kelly • March 16, 2021

Bayer posts second analysis of Essure adverse events taken from social media

The latest data shows reports of 11,830 serious injuries, 45 malfunctions and nine deaths, but the FDA advised against drawing conclusions. Bayer pulled the device from the U.S. market in 2018 and still defends its safety.

By Nick Paul Taylor • Updated March 17, 2021

1 year after COVID-19 hit: what's next for FDA, electives, testing and robotics

The medtech industry has ridden a roller coaster of steep demand for novel diagnostics and a plunge in once-stable business lines like hip and knee replacement surgeries.

March 15, 2021

5 things medtech can expect from FDA in 2021

"What you saw under the prior administration was this concept of a kinder, softer FDA to industry," said Dennis Gucciardo, partner at Morgan Lewis. Experts now expect a shift, including more enforcement activity.

By Greg Slabodkin • March 15, 2021

FDA flags false positives from Roche's COVID-19-flu test

The agency is asking users who suspect their systems are suffering from either issue identified by the Swiss medtech giant to stop running tests on them and contact the company.

By Nick Paul Taylor • March 15, 2021

Hospitals lift curtain on prices, revealing giant swings for hips, knees and more

At a Sutter hospital in San Francisco, a joint replacement ranges from $22,865 to $101,571, accordind to a Healthcare Dive analysis of data hospitals are required to report as of January. 

By Samantha Liss , Nami Sumida • March 11, 2021

CMS pushes back kidney care payment model start date to January 2022

The rule incentivizes delivery of at-home dialysis care with increased payments. Baxter and Outset Medical are among those that pushed for the changes.

By Rebecca Pifer • March 11, 2021

Docs writing in NEJM push CMS to drop breakthrough payment rule

Rescinding the rule would stop a change analysts saw as a "significant commercial tailwind" for companies including Abbott, J&J and Medtronic.

By Nick Paul Taylor • March 11, 2021

Vast majority of hospitals say they have an AI strategy, up from just half last year

AI technologies have also caught the attention of the medical device industry, with top medtechs like Medtronic, GE Healthcare and Philips investing in the space.

By Rebecca Pifer • March 10, 2021

EU remote audits under MDR in doubt as divergent national positions persist

Team-NB pulled a proposal unveiled in February amid sustained resistance. A Commission medical device group met last week but has yet to disclose a solution.

By Nick Paul Taylor • March 10, 2021

Intersect touts CMS coverage changes as boon for patient, physician access

The agency published an average selling price for Intersect's corticosteroid-eluting sinus implant treatment for nasal polyps, which "should help clarify payment and ease payor coverage adjudication," SVB Leerink analysts wrote.

By Nick Paul Taylor • March 9, 2021

Coronavirus relief bill with rural hospital aid, over $47B for testing passes Senate

The nearly $2 trillion bill includes $47.8 billion to boost COVID-19 testing and contact tracing efforts, including supporting the development, manufacturing and administering of tests.

By Shannon Muchmore • March 8, 2021

FDA grants first EUA to at-home OTC molecular test for COVID-19

Cue Health received the emergency authorization and expects to be able to produce more than 100,000 tests a day by the summer, as the agency continues to prioritize more at-home testing options.

By Nick Paul Taylor • March 8, 2021

Backing for telehealth Medicare reimbursement gains steam in Congress

Tuesday's House committee mirrored similar Senate panels. There's bipartisan support for a permanent expansion to a greater share of the population, but legislators are split on what form it should take. 

By Rebecca Pifer • March 5, 2021

4 healthcare antitrust issues to watch

The FTC is looking to get more aggressive with anticompetitive tie-ups while states eye ways to beef up oversight. And if handed the reins of HHS, Xavier Becerra would likely put an antitrust lens to potential rules.

By Samantha Liss • March 4, 2021

Becerra's HHS secretary bid moves forward on tie committee vote

White House press secretary Jen Psaki said Wednesday the president remained "confidently behind the nomination" despite the close committee vote.

By Shannon Muchmore • Updated March 4, 2021

FDA lays out data modernization action plan

"Even small advances in our ability to gain useful insights from data can represent significant opportunities," Janet Woodcock and Amy Abernethy, respectively FDA's acting commissioner and acting CIO, wrote.

By Nick Paul Taylor • March 4, 2021

FDA clamps down on bogus device 'registration certificates' amid rising use during pandemic

The agency sent letters to 25 companies after identifying a boost in use of materials "deceptively indicating" it had assessed medical devices.

By Nick Paul Taylor • March 4, 2021

FDA breakthrough roundup: Cook Medical is latest in round of cardio-themed nods

The company, among a slew of recent designations granting enhanced feedback and speedier review, plans to file to run a pivotal trial of its Zenith Fenestrated+ Endovascular Graft this year.

By Nick Paul Taylor • March 3, 2021