FDA: Page 60
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Roche and Siemens COVID-19 antibody tests shine in FDA accuracy roundup
Abbott's tests seemed to perform slightly worse than the best serology assays but comparably to kits from some other leading diagnostic players such as Beckman Coulter.
By Nick Paul Taylor • Dec. 14, 2020 -
Courtesy of BioNTech
In milestone, FDA clears coronavirus vaccine from Pfizer, BioNTech for emergency use
Vaccinations are expected to begin within days of the historic decision, which follows early approvals in the U.K., Canada and Mexico.
By Jonathan Gardner • Dec. 11, 2020 -
Explore the Trendline➔
Courtesy of Intuitive Surgical
TrendlineTop 5 stories from MedTech Dive
From the top medtech trends to watch in 2026 to haphazard layoffs at the Food and Drug Administration and the evolving use of AI in the medtech sector, here is a collection of top stories from MedTech Dive.
By MedTech Dive staff -
Alex Wong via Getty Images
Trump admin proposes easing HIPAA to foster value-based care, COVID-19 contact tracing
One goal in revamping the privacy regulations was to make information sharing more efficient, especially during health crises like the opioid epidemic and the coronavirus outbreak, according to top health officials.
By Rebecca Pifer Parduhn • Dec. 11, 2020 -
UK shares post-Brexit device guidance as uncertainty around EU split looms
MHRA this week outlined which medtech manufacturers will need to register and when. The timeline is determined by the previously disclosed grace period which ends Jan. 1, 2021.
By Nick Paul Taylor • Dec. 11, 2020 -
Yujin Kim / MedTech Dive, original photo courtesy of U.S. Food and Drug Administration
FDA advisers back Pfizer, BioNTech vaccine, clearing way for emergency approval
A panel of independent experts agreed the benefits of vaccination outweigh the risk, convinced by strong data showing the companies' shot to be 95% effective in preventing COVID-19.
By Ned Pagliarulo • Updated Dec. 10, 2020 -
Jacob Bell/MedTech Dive
LabCorp gets EUA for first at-home collection COVID-19 test with no prescription
The lab giant is selling the kit through its consumer-focused Pixel website and may expand into retail channels. The agency is hoping the over-the-counter diagnostic will spur more testing.
By Nick Paul Taylor • Dec. 10, 2020 -
Permission granted by Roche
Roche, Thermo Fisher ally with COVID-19 vaccine developers on antibody testing
The companies are working with Moderna and the University of Oxford to quantitatively measure the antibody levels of recipients of the shots.
By Nick Paul Taylor • Dec. 10, 2020 -
Alex Wong via Getty Images
Dive Awards
Regulatory Disruption of the Year: HHS lab developed test policy
The surprise move to no longer require FDA premarket review for laboratory developed tests spurred backlash across a spectrum of public health experts and industry.
By Greg Slabodkin • Dec. 9, 2020 -
Brian Tucker/MedTech Dive
Dive Awards
The MedTech Dive Awards for 2020
From the relentless demand for COVID-19 tests to the pressure on medtechs' traditional business lines, the industry has faced unprecedented market forces this year.
By MedTech Dive Team • Dec. 9, 2020 -
Hospitals prepare to reveal prices online come Jan. 1
The rule requires hospitals to prepare a list of pricing information for 300 "shoppable services," such as total knee replacements. However, experts question if the data will benefit consumers.
By Samantha Liss • Dec. 8, 2020 -
ACA defender Becerra tapped for Biden's HHS chief
The California attorney general has voiced opposition to provider consolidation in his state, alleging anticompetitive practices by regional powerhouse Sutter Health and denying a hospital system merger.
By Shannon Muchmore • Dec. 7, 2020 -
Endologix AAA graft to go before FDA panel over potential life-threatening leak risk
The agency also released postmarketing data reinforcing an increased likelihood of blood leaking into the aneurysm for patients with the company's AFX endovascular grafts.
By Susan Kelly • Dec. 7, 2020 -
Retrieved from Quest Diagnostics, PRNewswire on May 29, 2020
Quest gets first FDA nod for at-home collection coronavirus-flu combo test
The lab giant is using Roche’s diagnostic and instrument, which received an emergency use authorization in September, with its own process for testing samples collected by consumers.
By Nick Paul Taylor • Dec. 7, 2020 -
Siemens COVID-19 test gets high marks on FDA sensitivity list, beating Abbott, BD and Roche
A PerkinElmer test still holds the top position among coronavirus diagnostics least likely to return false negatives.
By Nick Paul Taylor • Dec. 4, 2020 -
CDRH headed for 'reset' in 2021 after COVID-19 derailed priorities, Shuren says
After a "massive increase" in work due to the pandemic, the device center anticipates continuing to manage coronavirus projects while also focusing on MDUFA V and new programs.
By Ricky Zipp • Dec. 3, 2020 -
CMS adds hip replacements, other surgeries to ASC list in final rule
A representative from Stryker applauded the changes and said the rule will encourage providers to consider the shift to ambulatory surgery centers.
By Ricky Zipp • Updated Dec. 4, 2020 -
EU underscores remote notified body audit policy amid pandemic
MedTech Europe has pressed the Commission to expand such reviews to the incoming MDR and IVDR regs, but a new Q&A notes the scope is limited to the directives and devices considered "clinically necessary" during the crisis.
By Nick Paul Taylor • Dec. 3, 2020 -
Courtesy of Abbott
CMS finalizes expanded artificial heart, ventricular assist device coverage
Medicare will cover artificial hearts outside of clinical studies and align VAD coverage criteria with medical practice. Cowen called the decision good for Abbott and Medtronic.
By Nick Paul Taylor • Dec. 2, 2020 -
Alex Wong via Getty Images
CMS makes some telehealth coverage permanent, finalizes specialty rate cuts
Areas getting pay slashed include thoracic and cardiac surgery and interventional radiology, Credit Suisse analysts said. Surgeon groups decried the changes.
By Rebecca Pifer Parduhn • Dec. 2, 2020 -
Digital therapeutic De Novos climb with FDA nod to IBS treatment
Despite a series of first-of-their-kind authorizations for such tech, total 2020 De Novo OKs currently match a 2019 low in recent years.
By Maria Rachal • Dec. 1, 2020 -
Permission granted by iRhythm Technologies
iRhythm gains UK support for EKG system while awaiting key final rule from CMS
The ambulatory cardiac monitoring system is one of just six medtech products recommended this year in guidance from the U.K. National Institute for Health and Care Excellence. The focus is on individuals with suspected arrhythmias.
By Maria Rachal • Dec. 1, 2020 -
CMS expands ability for hospital-level care at home ahead of holiday virus spread
Six health systems received waivers to treat more than 60 acute conditions under the new program, which also tweaks earlier changes allowing ambulatory surgical centers to provide greater inpatient care.
By Shannon Muchmore • Nov. 30, 2020 -
IVDR notified body count inches up to 5 with TÜV Rheinland designation
The medtech notified bodies trade group urged swift action on potentially delaying the start date for the In Vitro Diagnostic Regulation if designations don't more than double by year's end.
By Nick Paul Taylor • Updated Nov. 30, 2020 -
Jacob Bell/MedTech Dive
Breast cancer tech among FDA's latest breakthrough nods
Over the past month, designations for speedier review have also ranged from a migraine treatment to tissue regeneration tech for spinal cord injuries.
By Susan Kelly • Nov. 24, 2020 -
Medical device makers get more flexibility with value-based care in Stark, anti-kickback final rules
The changes include two safe harbor pathways and "allow you to do things that otherwise might violate the kickback statute or the Stark Law. So, that is always welcome in the industry," one lawyer said.
By Ricky Zipp • Nov. 24, 2020
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