FDA: Page 55
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Medtronic's Harmony pulmonary valve wins FDA approval
The device is the first non-surgical heart valve cleared in the U.S. to treat a severe form of pulmonary valve regurgitation that usually results from a congenital heart defect.
By Susan Kelly • March 29, 2021 -
Boston Scientific links just approved liver cancer device to improved survival
Analysts at Evercore ISI estimate FDA clearance for the radioactive glass beads opens up a $150 million U.S. market opportunity, although they note lack of data from a randomized trial "could be a factor in modeling adoption."
By Nick Paul Taylor • March 26, 2021 -
Explore the Trendlineâž”
Permission granted by Boston Scientific
TrendlineNew medical devices are reshaping the medtech industry
From pulsed field ablation devices to glucose sensors and surgical robotics, new medical technologies are transforming patient care and how people manage their health.
By MedTech Dive staff -
Abbott, Quest, Roche among cos pitching K-12 COVID-19 test plan to tap into Biden's $10B fund
A who's who of sector companies are teaming with the Rockefeller Foundation on the proposal. The industry stands to benefit from widespread school testing as symptomatic demand diminishes.
By Nick Paul Taylor • March 26, 2021 -
Alex Wong via Getty Images
Hospitals flailed amid COVID-19 crisis, are unsure of future, OIG says
Executives said they were worried about their workers experiencing trauma and concerned a shrinking recruitment pool for nurses could exacerbate staffing shortages.
By Ron Shinkman • March 25, 2021 -
Boston Scientific to pay $188.6M to settle mesh claims in 47 states
The agreement with the attorneys general settles allegations the medtech giant misrepresented or failed to disclose to patients all of the potential risks involved with the vaginal implants.
By Susan Kelly • March 24, 2021 -
Alex Wong via Getty Images
Baxter, digital health startups lead pushback against 510(k) exemptions
Companies argued in public comments that relaxing certain FDA regulations could put consumer safety at risk. Roche was a rare supporter, arguing the changes would "free up much needed FDA resources."
By Nick Paul Taylor • March 23, 2021 -
AstraZeneca, Oxford vaccine prevents COVID-19 in big US study amid controversy overseas
A two-shot regimen was 79% effective at protecting people from COVID-19, which should support the fourth clearance of a vaccine in the U.S. and calm safety concerns abroad.
By Ben Fidler • March 22, 2021 -
FDA grants EUA to COVID-19 screening device using machine learning
While the product gives institutions another screening tool for those without symptoms, Tiger Tech faces competition with antigen testing scaling up.
By Nick Paul Taylor • March 22, 2021 -
EU group proposes minimum standards for rapid antibody COVID-19 tests
Antibody tests of questionable accuracy proliferated on both sides of the Atlantic early in the pandemic, leading the U.S. and European Union to try to raise standards.
By Nick Paul Taylor • March 19, 2021 -
Adeline Kon/MedTech Dive
ASCs gave medtechs alternate care sites amid pandemic hospital elective shutdown
After surgeries moved to ambulatory surgery centers during the pandemic's upending of non-emergency care, experts and industry believe some procedures may never go back.
By Ricky Zipp • March 19, 2021 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel coronavirus SARS-CoV-2" [Microscope image]. Retrieved from https://www.flickr.com/photos/nihgov/49535193876/in/album-72157713108522106/.
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 -
Courtesy of Abbott Labs
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 -
Deep Dive
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 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Image]. Retrieved from Flickr.
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 -
Getty Images
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 -
Getty Images
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 -
Adeline Kon/MedTech Dive
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 -
Yujin Kim / MedTech Dive, original photo courtesy of U.S. Food and Drug Administration
Deep Dive5 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 -
Deep DiveHospitals 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 -
Alex Wong via Getty Images
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 Parduhn • March 11, 2021 -
Alex Wong via Getty Images
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 Parduhn • March 10, 2021
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