FDA: Page 56
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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 -
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 -
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 Parduhn • March 5, 2021 -
Brian Tucker/MedTech Dive
Deep Dive4 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 -
Retrieved from C-SPAN on February 24, 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 -
Jacob Bell/MedTech Dive
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 -
Quidel, Eurofins get EUAs as at-home COVID-19 test market heats up
The companies join Abbott, Ellume and Lucira with FDA-authorized offerings. A Craig-Hallum analyst called the emergency use authorization "the first step in morphing at-home testing into a multi-billion-dollar market."
By Nick Paul Taylor • March 2, 2021 -
Medtronic's HeartWare receives another Class I recall after more patient deaths
The medical device giant is recalling 157 HVAD Pump Implant Kits from the U.S. after receiving complaints that some devices failed to start or restart promptly.
By Nick Paul Taylor • March 2, 2021 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
CMS moves to stop COVID-19 testing denials, cost sharing in private plans
The trade group for Quest and LabCorp praised what it called "decisive action" by the Biden administration to close coverage gaps that have denied people access to tests.
By Nick Paul Taylor • March 1, 2021 -
FDA OKs device to avert traumatic brain injury during sports
Approval was based in part on a study of 284 U.S. high school football players, suggesting the neck-worn product can minimize "slosh" in the brain that occurs in unprotected athletes who suffer head impacts.
By Nick Paul Taylor • March 1, 2021 -
Permission granted by Johnson & Johnson
J&J's single-dose coronavirus vaccine becomes third authorized in US
A CDC vaccine panel recommended use of the shot on Sunday following FDA authorization, and McKesson began shipping out doses to states Monday.
By Ned Pagliarulo • Updated March 1, 2021 -
Permission granted by iRhythm Technologies
iRhythm still faces reimbursement uncertainty after meetings with Medicare rate negotiator
CEO Michael Coyle said the cardiac monitoring company and other industry representatives met with a Medicare Administrative Contractor twice, but added that there are no assurances rates will come up.
By Ricky Zipp • Feb. 26, 2021 -
Retrieved from C-SPAN on February 23, 2021
Becerra backs price transparency, provider competition at first Senate panel
President Joe Biden's pick for HHS chief turns Wednesday to the finance panel, which will vote on sending the nomination to the full Senate.
By Shannon Muchmore • Feb. 24, 2021 -
Retrieved from The White House/YouTube on January 21, 2021
ACLA urges Biden to fund uninsured COVID-19 testing, close coverage loopholes
The plea from the trade group for Quest and LabCorp is the latest in a row between labs and insurers over paying for the diagnostics and comes as a $2 billion federal testing fund runs dry.
By Nick Paul Taylor • Feb. 24, 2021 -
UK adopts medical device legislation, setting stage for new databases and sanctions
Politicians framed the new law as furthering efforts to fix failings that delayed regulatory responses to safety problems with products including pelvic mesh.
By Nick Paul Taylor • Feb. 24, 2021 -
Jacob Bell/MedTech Dive
FDA lays path to weigh virus variant impact on COVID-19 test results
The agency wants diagnostic companies to factor the potential for variants to evade detection into their test development and monitoring, Center for Devices and Radiological Health chief Jeff Shuren said.
By Nick Paul Taylor • Feb. 23, 2021 -
FDA starts review of how skin pigmentation affects pulse oximeter results
The agency is evaluating published literature related to factors that may affect device accuracy and performance, following pressure from senators to address concerns that "racism may be embedded in key clinical tools."
By Nick Paul Taylor • Feb. 22, 2021 -
Boston Scientific's ICD recall gets 2nd Class I label from FDA
A new agency notice covers a fault that allows moisture to enter the medical device, causing it to short circuit when it tries to shock the patient. Boston Scientific has not received reports of injuries or deaths linked to the problem.
By Nick Paul Taylor • Feb. 22, 2021 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
Why this week's FDA meeting on J&J's coronavirus vaccine will be important
The agency is widely expected to OK the one-dose shot, but the advisory panel will offer a window into debate over several key issues, including related to the new virus variants.
By Ben Fidler , Ned Pagliarulo • Feb. 22, 2021 -
Retrieved from Manatt on February 18, 2021
Obama admin alum Chiquita Brooks-LaSure tapped to head CMS
AdvaMed backed the nomination, noting a new Medicare rule that gives developers of FDA-designated breakthrough devices the potential to sell them and be reimbursed on the day of market approval.
By Shannon Muchmore • Feb. 18, 2021 -
BD drug-coated balloon falls short at FDA panel, signaling likely rejection
While the advisory committee largely agreed that Lutonix was safe, the majority did not believe it was effective nor that the benefits outweighed the risks.
By Ricky Zipp • Feb. 18, 2021
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