FDA: Page 61
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LabCorp COVID-19 test gets 1st FDA OK for asymptomatic screening
U.S. regulators simultaneously allowed the LabCorp test to be used in sample pooling, following the first such nod to a Quest Diagnostics test a week ago.
By Nick Paul Taylor • July 27, 2020 -
HHS renews COVID-19 public health emergency
The extension supported by AdvaMed, the American Clinical Laboratory Association and American Hospital Association takes effect Saturday and opens the door for FDA to keep issuing emergency use authorizations.
By Shannon Muchmore • July 23, 2020 -
Explore the Trendline➔
Sitthiphong via Getty Images
TrendlineMedical device industry continues to turn to AI
While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.
By MedTech Dive staff -
4 healthcare sticking points as Congress weighs next coronavirus relief bill
Senate Republicans may limit allocations for testing efforts, as labs struggle to keep up with demand and return results in a timely enough fashion to leverage contact tracing.
By Rebecca Pifer , Samantha Liss • July 21, 2020 -
FDA eases rules on viral transport media to boost availability for COVID-19 testing
In some cases, a dearth of key materials has constricted efforts to widen COVID-19 testing. Now, the agency is allowing commercial manufacturers to ship products without filing a 510(k) or meeting UDI requirements.
By Nick Paul Taylor • July 21, 2020 -
Courtesy of Quest Diagnostics
Quest coronavirus test becomes 1st with FDA OK for sample pooling
The technique is "not a magic bullet," Quest's chief medical officer said, with demand for its COVID-19 services still overwhelming capacity. However, rival LabCorp said it has reduced its average turnaround time for results.
By Maria Rachal • July 20, 2020 -
Courtesy of Quest Diagnostics
3 Quest COVID-19 assays get FDA OK for at-home collection via telehealth
The agency this week granted new emergency use authorizations to three tests, previously granted EUAs, so users can self-collect nasal swab samples while being observed by a healthcare provider remotely.
By Greg Slabodkin • July 17, 2020 -
Courtesy of Ambu
Ambu wins FDA clearance for single-use duodenoscope product
Boston Scientific was first to obtain an agency nod for a fully disposable version, meant to be safer against infection, which it believes could be worth more than $1 billion.
By Maria Rachal • July 17, 2020 -
UK signals Stryker offer to unload ankle replacement product could clear Wright Medical buy
The medtech giant's proposed $4 billion acquisition prompted competition concerns among regulators. Stryker disclosed in a filing Wednesday it pitched divesting its STAR product line, which may satisfy U.K. authorities.
By Greg Slabodkin • July 15, 2020 -
FDA commits to staggered move to electronic medtech filings
Finalized guidance on electronic submissions of medical device regulatory filings takes into account AdvaMed comments on timing.
By Nick Paul Taylor • July 15, 2020 -
FDA proposes BPH device trial guidance changes as market heats up
The updates come as a swath of companies take aim at the benign prostatic hyperplasia opportunity, which medtechs like Boston Scientific and Teleflex have invested in more since FDA issued development guidance a decade ago.
By Nick Paul Taylor • July 14, 2020 -
FDA plans to restart domestic inspections, contingent on local coronavirus trends
The agency is aiming to resume some on-site surveillance the week of July 20 after shutting down non-critical inspections in March due to the COVID-19 outbreak.
By Maria Rachal • July 10, 2020 -
Shannon Muchmore/MedTech Dive
Lab groups ask Trump admin for more transparency into COVID-19 testing supply allocation
Eight organizations representing laboratory professionals asked the White House Coronavirus Task Force to address ongoing obstacles to performing tests.
By Greg Slabodkin • July 10, 2020 -
IVDR implementation by 2022 'highly doubtful,' trade group warns
MedTech Europe is ramping up calls for the European Commission to rethink plans for the roll-in of the In Vitro Diagnostic Regulation in light of the ongoing COVID-19 pandemic.
By Nick Paul Taylor • July 10, 2020 -
Courtesy of Stop Medical Distancing
LabCorp, McKesson back COVID-19 ad campaign urging patients to stop 'medical distancing'
The effort by a coalition of providers, payers and other firms is aimed at reviving elective procedures that were largely halted amid the pandemic.
By Shannon Muchmore • July 8, 2020 -
Labs, ASCs get slice of $521B in COVID-19 paycheck protection loans
Federal dollars flowing to hundreds of ambulatory surgery centers could benefit medtechs hoping outpatient facilities help elective procedures rebound more quickly, as hospitals in hotspots still restrict non-urgent care.
By Maria Rachal • July 8, 2020 -
"White House Press Briefing". Retrieved from The White House.
As LabCorp, Quest feel COVID-19 strain, Trump admin pegs hopes on POC tests
Brett Giroir, the administration's lead for coronavirus diagnostics, said the goal is for rapid point-of-care tests from Abbott, BD and Quidel, performed outside of lab settings, to alleviate commercial testing capacity constraints.
By Greg Slabodkin • July 8, 2020 -
Newest Medtronic implantable heart monitor gets FDA nod as remote device features proliferate
The U.S. marketing clearance comes on the heels of an FDA nod for Boston Scientific's LUX-Dx insertable cardiac monitor, which also can be programmed remotely by a physician.
By Susan Kelly • July 8, 2020 -
'If the public knew:' Ripple20 shows medical device software cyber weakness
Last month’s discovery that Baxter and B. Braun infusion pumps face risk of remote attacks by hackers comes as a medtech effort gains momentum to track third-party components in devices.
By Greg Slabodkin • July 7, 2020 -
FDA warns of false positives with BD coronavirus diagnostic
On the heels of greenlighting BD's antigen test, FDA flagged an issue with its molecular test offering, telling healthcare professionals to treat positive results as “presumptive” and consider confirming findings via a different test.
By Nick Paul Taylor • July 7, 2020 -
OTC hearing aid proposal, EtO sterilizer rule make 2020 regulatory agenda
Federal agencies also aim by year's end to issue updates to radiological health regulations, changes to the De Novo application process and modifications to streamline Medicare coverage of breakthrough technologies.
By Maria Rachal • July 2, 2020 -
FDA delays UDI enforcement amid COVID-19, ongoing technical issues
The agency is holding off on enforcing unique device identification regulations until September 2022, four years later than was originally planned.
By Nick Paul Taylor • July 2, 2020 -
CMS proposes major market expansion in potential boost for Abbott's MitraClip
Analysts at Cowen estimate the agency's proposal could double or triple the number of U.S. mitral regurgitation patients eligible for the treatment.
By Nick Paul Taylor • July 1, 2020 -
Notified body poll finds multi-month waits for COVID-19 conformity assessments
More than half surveyed by the European Commission expect to spend six months to a year processing applications for certain devices addressing coronavirus.
By Nick Paul Taylor • July 1, 2020 -
Alex Wong via Getty Images
HHS 'expects to renew' COVID-19 emergency, spokesperson says
The department did not respond to requests for comment Tuesday morning. The public health emergency is currently set to expire at the end of July.
By Shannon Muchmore • June 30, 2020 -
As Beckman enters US COVID-19 antibody market, how do rivals compare?
Comparing the accuracy of the Danaher subsidiary's test to products from big rivals like Abbott, Roche and Siemens Healthineers depends on who's doing the assessment and when a sample is taken.
By Nick Paul Taylor • June 30, 2020
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