FDA: Page 49
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Retrieved from C-SPAN on February 23, 2021
HHS warns providers, insurers COVID-19 testing must be free for patients
The American Clinical Laboratory Association, which includes Quest Diagnostics and LabCorp, has complained that guidance on the topic had only served to muddy what they saw as clear congressional mandates.
By Greg Slabodkin • June 10, 2021 -
EU provides plan to meet 'serious challenge' of readiness for IVDR
The document by the Medical Device Coordination Group is designed to ensure "limited resources" are focused on the activities that are critical to being ready by May 2022.
By Nick Paul Taylor • June 10, 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 -
Jacob Bell/MedTech Dive
FDA lays out device cybersecurity efforts as feds look to implement Biden executive order
The president signed an order last month seeking to bolster the nation's cyber posture amid growing threats from hackers.
By Greg Slabodkin • June 9, 2021 -
'Covid hangover' to spur health costs to rise 6.5% in 2022, PwC poll predicts
PwC found, however, that a greater reliance on lower-cost sites of care like virtual visits and retail clinics could help offset higher usage of medical services.
By Hailey Mensik • June 9, 2021 -
Justin Sullivan via Getty Images
Amazon offers COVID-19 test online to consumers with a website for viewing results
The tech giant's coronavirus diagnostic, which received FDA emergency authorization in March, was originally designed for use by company employees but is now available for $39.99 to the public.
By Nick Paul Taylor • Updated June 16, 2021 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
OraSure gets EUAs to enter shrinking COVID-19 antigen test market
The technology is differentiated from other rapid antigen tests but is coming to market amid what Abbott characterized as a "sharp and rapid" drop in demand.
By Nick Paul Taylor • June 8, 2021 -
Medtronic's HVAD controversy
Medtronic's HeartWare HVAD ending brings questions about $1B acquisition
Nearly five years after Medtronic's buy of HeartWare International, the medtech giant pulled the flagship product of the deal due to safety risks, ceding the market to rival Abbott.
By Ricky Zipp • June 8, 2021 -
Medtronic lands FDA approval for brain stimulation leads it expects to drive share gains
CEO Geoff Martha has boasted the nod for SenSight will help it close "a key competitive gap." The medtech competes with Abbott and Boston Scientific in the market.
By Nick Paul Taylor • June 8, 2021 -
Sarah Silbiger via Getty Images
Cancer tech dominates FDA's latest batch of breakthrough devices
The agency's recent breakthrough designations feature a clutch of oncology devices and diagnostics from companies including Viome and Avenda Health.
By Nick Paul Taylor • June 7, 2021 -
UnitedHealthcare to crack down on ER visits, potentially exposing patients to bigger bills
If the largest private payer finds the trip was not an emergency, the visit will be "subject to no coverage or limited coverage," the provider alert states. Anthem faced backlash for a similar policy several years ago.
By Samantha Liss • June 4, 2021 -
Alex Wong via Getty Images
CMS' Fowler: More mandatory payment models likely
"I recognize those come with their own set of disadvantages ... But I support this direction," CMMI head Elizabeth Fowler said Thursday.
By Rebecca Pifer • June 3, 2021 -
Medtronic's HVAD controversy
Medtronic pulls HeartWare HVAD pump from market amid recalls, patient deaths
The medtech said the move was influenced by growing evidence the system had higher mortality risks than comparable devices. FDA advised providers to use Abbott's HeartMate 3 as an alternative.
By Ricky Zipp • June 3, 2021 -
Sarah Silbiger via Getty Images
FDA warns device makers of falsified records at Italian ethylene oxide sterilization facilities
BD and Medtronic are among those that already recalled products processed by Steril Milano, accused by the agency of falsifying graphs and parameters of sterilization certificates for a variety of products dating back to 2016.
By Nick Paul Taylor • June 3, 2021 -
Jacob Bell/MedTech Dive
Cognoa's machine learning software for autism diagnosis gets FDA nod
The software as a medical device, which uses an algorithm, reports a positive or negative diagnosis based on analyses of videos of the child and other information. The product got FDA's breakthrough designation in early 2019.
By Nick Paul Taylor • June 3, 2021 -
Retrieved from National Cancer Institute on September 27, 2019
In first, FDA approves KRAS-blocking cancer drug from Amgen
After decades of scientists unsuccessfully targeting the KRAS gene, Lumakras is the first drug proven effective. The FDA Friday also approved companion diagnostics from Qiagen and Guardant Health.
By Ned Pagliarulo • Updated May 29, 2021 -
Sarah Silbiger via Getty Images
FDA seeks 8% budget boost for CDRH to back resurgence of domestic device production
The Biden administration said its request for the Center for Devices and Radiological Health will help the U.S. reduce reliance on products from China and other countries and strengthen its ability to respond to emergencies.
By Nick Paul Taylor • June 1, 2021 -
ACLA appeals dismissal of PAMA lawsuit, pushes legislative fixes
The lab trade group for Quest, LabCorp and others argues the Protecting Access to Medicare Act is a case of "harmful regulatory overreach" that forces an "unsustainable reimbursement model" on its members.
By Nick Paul Taylor • June 1, 2021 -
Swiss medtech sounds alarm as MDR erects barriers to EU market
The Swiss Medical Technology Association said the change will cost the industry it represents the equivalent of $126 million to meet new administrative requirements.
By Nick Paul Taylor • May 28, 2021 -
Joe Raedle via Getty Images
Rising hospital ransomware attacks could endanger patients, hit bottom lines hard, Moody's says
Systems have been rendered more vulnerable due to COVID-19 as more non-clinical employees work from home. The warning echos comments made recently by the FDA's cyber chief for medical devices.
By Ron Shinkman • May 27, 2021 -
Sarah Silbiger via Getty Images
FDA draft guidances lay out postmarket medical device data requirements
Building on existing policy, one proposal deals with rules for Class II and III products while another relates to PMAs.
By Nick Paul Taylor • May 27, 2021 -
Courtesy of Abbott, PRNewswire
HHS commits $4.8B to COVID-19 testing for the uninsured
The American Clinical Laboratory Association, with members including LabCorp and Quest Diagnostics, had urged the Biden administration in February to make more money available.
By Susan Kelly • May 26, 2021 -
MDR challenges remain as regulation goes into effect: MedTech Europe
The European trade group contends that while the Medical Device Regulation's May 26 effective date marks a significant milestone, hurdles limit industry’s ability to "seamlessly supply certified devices under the new rules."
By Greg Slabodkin • May 26, 2021 -
Senate confirms Chiquita Brooks-LaSure as head of CMS
AdvaMed and MDMA both called out the Medicare Coverage of Innovative Technology rule, now delayed, as a priority for the new administrator. President Joe Biden has yet to name an FDA chief.
By Rebecca Pifer • May 25, 2021 -
Leon Neal via Getty Images
Ransomware, other cyber threats mount as medtech industry tries to adapt
"Everything is hackable," said Kevin Fu, the FDA's medical device cybersecurity chief, who noted that ransomware in particular can render a device useless.
By Greg Slabodkin • May 25, 2021 -
Sarah Silbiger via Getty Images
FDA clears 2 endoscopes that avoid reprocessing
The agency, which has urged a shift to endoscopes with single-use parts or that are fully disposable, gave the OK to UroViu to market a single-use cytoscope and to China's EndoFresh for a disposable digestive endoscopy system.
By Susan Kelly • May 25, 2021
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