FDA: Page 48
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Courtesy of Abbott
Abbott gets CE mark to sell COVID-19 antigen test directly to consumers in Europe
The company's rapid Panbio diagnostic received the marking in January for asymptomatic coronavirus screening. However, the test missed half of COVID-19 cases in people without symptoms, according to a recent Irish study.
By Greg Slabodkin • June 28, 2021 -
Permission granted by E.A. Crunden
Lawmakers reintroduce diagnostic regulation bill that split the industry
The VALID Act would create a risk-based regulatory framework for in vitro diagnostics and laboratory-developed tests. ACLA, whose members include Quest and LabCorp, is reviewing the bill but has objected to earlier drafts.
By Nick Paul Taylor • June 25, 2021 -
Explore the Trendline➔
Sara Silbiger via Getty Images
TrendlineTop 5 stories from MedTech Dive
From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.
By MedTech Dive staff -
EU clarifies Eudamed rules for legacy and custom-made devices
The Medical Device Coordination Group has provided information on products placed on the market under frameworks other than MDR and IVDR, which the advisers said should be registered in the database.
By Nick Paul Taylor • June 25, 2021 -
Stock Photo via Getty Images
More than 1/3 of health organizations hit by ransomware last year, report finds
Of those attacked, 65% said the criminals were successful in encrypting their data, according to the report from cybersecurity company Sophos.
By Rebecca Pifer • June 24, 2021 -
Medicare lacks cyber oversight of hospitals' networked medical devices: OIG
Without proper cybersecurity controls, these devices can be compromised with the potential for patient harm, according to the HHS watchdog. OIG wants CMS to do more to address hospital vulnerabilities.
By Nick Paul Taylor • June 24, 2021 -
Stefani Reynolds / Stringer via Getty Images
Contentious device breakthrough payment rule codified in Cures 2.0 proposal
The measure would sidestep CMS' delay of the MCIT pathway, which grants Medicare coverage to FDA-approved breakthrough devices.
By Nick Paul Taylor • June 24, 2021 -
An Rong Xu via Getty Images
AdvaMed urges Biden to prioritize medical supplies as industries suffer shipping constraints
CEO Scott Whitaker said transport challenges, including shipping container shortages and insufficient trucking capacity, have impeded the ability of medtechs to deliver products while also significantly driving up costs.
By Ricky Zipp • June 23, 2021 -
Deep Dive
Legacy medical devices, growing hacker threats create perfect storm of cybersecurity risks
Aging medtech and increasingly sophisticated criminals are leaving hospitals highly vulnerable to attacks.
By Greg Slabodkin • June 22, 2021 -
Adeline Kon/MedTech Dive
Black patients were more likely to die of COVID-19 largely due to inferior hospitals
A recent study in JAMA Network Open showed how inequities in housing influence where Black people seek care and how that affects the quality of care they receive.
By Samantha Liss • June 21, 2021 -
The Supreme Court saved the ACA, again. It may not be the last word on challenges.
Will the 7-to-2 ruling put future efforts on ice? Even staunch backers of the law expect opponents to "come up with something."
By Samantha Liss • June 21, 2021 -
Courtesy of Siemens Healthineers
UnitedHealthcare skimping on COVID-19 test pay: California doctors group
The California Medical Association says UnitedHealthcare still is not covering the cost of all COVID-19 diagnostic testing, despite state and federal guidelines that require the services to be provided at no cost to patients.
By Susan Kelly • June 21, 2021 -
Medicare CGM eligibility widened in potential boon for Abbott, Dexcom
CMS opened up coverage for therapeutic continuous glucose monitors, eliminating a rule that patients must use a blood glucose monitor and require at least four self-monitoring blood glucose tests per day to have devices covered.
By Ricky Zipp • June 18, 2021 -
UK extends OK of Innova COVID-19 test criticized by FDA in warning letter
While U.S. regulators told the public to put Innova tests in the trash, a review by the U.K. counterpart found no problems that warranted further actions.
By Nick Paul Taylor • June 18, 2021 -
FDA seeks feedback on distinction between device remanufacturing and servicing
The long-awaited draft guidance is meant to clarify a blurry line between the two processes. The Medical Imaging and Technology Alliance contends remanufacturing is being done by unregulated third-party device servicers.
By Nick Paul Taylor • June 18, 2021 -
Roundup: Medtronic's HVAD recall problems continue following patient injuries, deaths
One year after Medtronic pulled the heart pump off the market, there have been two Class I recalls following reports of patient injuries and deaths. Here is a collection of MedTech Dive's coverage of the HVAD saga.
Updated June 27, 2022 -
Alex Wong via Getty Images
Hip, knee bundled pay program results similar as voluntary or mandatory: JAMA study
The results of a University of Pennsylvania analysis of more than a million Medicare claims for joint replacement surgery lend support to CMS' expected policy shift toward more mandatory bundled payment arrangements.
By Susan Kelly • June 16, 2021 -
Jacob Bell/MedTech Dive
Public Citizen calls for top FDA officials to resign following Alzheimer's drug approval
The consumer group wants Janet Woodcock, Patrizia Cavazzoni and Billy Dunn to step down over last week's controversial approval of Aduhelm, which is expected to put immense strain on healthcare budgets.
By Jacob Bell • June 16, 2021 -
Sarah Silbiger via Getty Images
LetsGetChecked receives EUA for use of at-home COVID-19 collection kit by minors
The virtual healthcare company, which last week announced $150 million in Series D financing, is competing with companies including LabCorp for the pediatric testing market.
By Nick Paul Taylor • June 16, 2021 -
Stefani Reynolds / Stringer via Getty Images
MedPAC says lower clinical lab fees don't impact access, prompting ACLA ire
The clinical laboratory group, whose members include Quest and LabCorp, contends that MedPAC's report to Congress contains "biased" commentary that ignores the value of lab tests and importance of timely patient access.
By Nick Paul Taylor • June 16, 2021 -
FDA advisory panel to review TransMedics' liver preservation device
The Gastroenterology and Urology Devices Panel will meet virtually on July 14 to discuss the company's filing for premarket approval of the OCS Liver system, which is designed to keep donor organs viable for longer.
By Nick Paul Taylor • June 15, 2021 -
Philips recalls 2021
ResMed's stock climbs following Philips' sleep apnea, ventilator device recall
Wall Street analysts wrote the recall could drive patients and durable medical equipment providers to ResMed devices, though any benefits right now are "impossible to quantify."
By Ricky Zipp • Updated June 16, 2021 -
Sarah Silbiger via Getty Images
FDA rejects Verily filing for wrist-worn Parkinson's clinical trial device
The sister company of Google developed the feature to collect data on the motor function of Parkinson's patients in between visits to trial sites. However, the agency questioned the wearable's ability to have a meaningful effect.
By Nick Paul Taylor • June 14, 2021 -
EC issues medtech guidance on implant cards required under MDR
The European Commission detailed information implant manufacturers need to provide under the new rules, while also publishing a document on the European Medical Device Nomenclature and how it relates to IMDRF terminology.
By Nick Paul Taylor • June 14, 2021 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Image]. Retrieved from Flickr.
FDA blasts Innova for shipping unapproved COVID-19 test, using false or misleading labeling
The agency hit the California-based medtech with a flurry of actions on Thursday, firing off a warning letter alongside notice of a Class I recall and a press release telling the public to stop using the antigen test.
By Nick Paul Taylor • Updated June 11, 2021 -
Medtronic's FDA approval sets up fight for recharge-free pain market
The medtech sees Vanta helping it gain share in a market it has struggled to penetrate in the past. Abbott Laboratories, Boston Scientific and specialist spinal cord stimulation rival Nevro are also competing.
By Nick Paul Taylor • June 11, 2021
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