FDA: Page 67
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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 -
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 -
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 -
FDA nod to Boston Scientific cardiac monitor clears challenge to Abbott, Medtronic
The medtech giant is betting remote adjustment will put its LUX-Dx insertable system in a position to take on rivals, which have a years-long head start.
By Nick Paul Taylor • June 29, 2020 -
Texas again halts elective surgeries, showing fragile nature of rebound
The renewed restrictions spurred questions about whether states or individual health systems in other hotspots like Arizona and California will enforce similar pullbacks in procedures.
By Maria Rachal • June 26, 2020 -
CMS wants to make home health telemedicine permanent after COVID-19
Agencies would be able to keep using the tech for beneficiaries under the Medicare home health benefit beyond the public health emergency, including remote patient monitoring, according to a proposed rule fact sheet.
By Rebecca Pifer Parduhn • June 26, 2020 -
Payer coverage of employer, surveillance COVID-19 tests not required, feds say
As return-to-work offerings proliferate from lab and pharmacy giants like Quest, LabCorp and CVS, new federal guidance says health insurers aren't obligated to pay for the testing services.
By Maria Rachal • June 25, 2020 -
Courtesy of Tandem Diabetes
FDA signals support for automated insulin dosing tech, backing new development tool
As the diabetes technologies meet regulators' safety and efficacy benchmarks, the agency wants to help developers assess patient and family-reported quality of life factors.
By Maria Rachal • June 25, 2020 -
"State Public Health Laboratory in Exton Tests for COVID-19" by Governor Tom Wolf is licensed under CC BY 2.0
UK study to validate, compare COVID-19 tests in real-world settings
The hospital arm will assess 10 to 20 new diagnostics the National Health Service has identified as high priority, including those designed to deliver results at the point of care in minutes, which could include Abbott’s ID NOW.
By Nick Paul Taylor • June 25, 2020 -
Screenshot of House E&C hearing, June 23, 2020
Fauci: Trump never asked to slow down testing, says US needs more, not less
During a House panel Tuesday, top U.S. infectious disease doctor Anthony Fauci and other public health officials denied they'd been directed to impede testing efforts as the White House targets up to 50 million tests a month by fall.
By Rebecca Pifer Parduhn • June 24, 2020 -
Medtronic Evolut TAVR system gets expanded label in Europe
New indications allow a less-invasive alternative to traditional open heart surgery for a group of severe aortic stenosis patients who tend to be younger and more active, and in higher-risk patients with bicuspid aortic valves.
By Susan Kelly • June 23, 2020 -
FDA affirms potential to miss MDUFA deadlines, weighs virtual advisory panels
Separately, the agency announced virtual meetings in September on using patient preference information in medical device regulatory decisions and considering patient-reported outcomes in evaluating devices.
By Nick Paul Taylor • June 23, 2020 -
FDA
Mainstay wins FDA approval for chronic back pain device following mixed clinical data
The premarket approval comes 19 months after the ReActiv8 neurostimulation system failed a clinical trial aimed at generating data to break into the U.S. market.
By Nick Paul Taylor • June 23, 2020 -
Dufour, Tia. (2020). "White House Press Briefing" [Photograph]. Retrieved from Flickr.
Pandemic pushes FDA to 'accelerate' real-world evidence efforts, Hahn says
The agency has grappled with how to leverage real-world data in regulating medical devices, and is now leaning on it to update emergency use authorizations, FDA chief Stephen Hahn said at a forum on Thursday.
By Maria Rachal • June 19, 2020 -
Lack of data encryption for Baxter devices flagged in flurry of DHS alerts
The Department of Homeland Security's cyber agency published four advisories, ranging from 7.5 to 8.6 on its 10-point severity scale, about vulnerabilities in infusion pumps, hemodialysis delivery systems and other tech.
By Nick Paul Taylor • June 19, 2020 -
Screenshot of virtual Senate HELP hearing, June 17, 2020
Senators back sustaining telehealth momentum post pandemic
Top priorities include axing geographic restrictions, expanding Medicare and Medicaid reimbursement for virtual care services, and upping use of remote patient monitoring and digital health tools for patients with chronic conditions.
By Rebecca Pifer Parduhn • June 18, 2020 -
Jacob Bell/MedTech Dive
FDA cracks down on sellers of at-home COVID-19 antibody tests
A series of warning letters is the latest example of U.S. regulators weeding out serology tests that don't meet the agency's standards.
By Nick Paul Taylor • June 18, 2020 -
TÜV SÜD becomes 4th notified body designated under IVDR
It's the first notified body OK'd by the European Commission in 2020 to increase capacity for the forthcoming In Vitro Diagnostic Regulation, set to come into force in less than two years.
By Nick Paul Taylor • June 18, 2020 -
Courtesy of Tandem Diabetes
Tandem's insulin dosing algorithm OK'd for use in younger kids
FDA's decision to expand the pediatric indication was supported by an NIH-funded trial that found the automated insulin dosing system helped improve time in range for children ages 6 to 13.
By Maria Rachal • June 17, 2020 -
Thermo Fisher, MedRhythms gain breakthrough device designations
A companion diagnostic for certain brain tumor patients and a digital therapeutic for stroke patients with walking impairments are among the latest technologies tapped by FDA for the priority review program.
By Susan Kelly • June 17, 2020 -
FDA revokes emergency authorization for Chembio's COVID-19 antibody test
It's the first time the agency has exercised such authority for a coronavirus test, citing more false results than expected. Chembio Diagnostics' stock plunged 60% Wednesday.
By Greg Slabodkin • June 17, 2020 -
Retrieved from Akili Interactive/Businesswire on June 15, 2020
In FDA 1st, game-based therapeutic gets marketing OK
Digital therapeutics developer Akili Interactive Labs won De Novo authorization for a treatment meant to improve attention function in children with ADHD, building on a rollout it began under a special COVID-19 policy.
By Maria Rachal • June 16, 2020 -
Heart rhythm bodies see 'clear concerns' with using wearables to detect arrhythmias
A paper published on Monday by the Heart Rhythm Society, along with counterpart groups in Asia, Europe and Latin America, found wearable-triggered false positives can cause unwarranted concerns and screening.
By Nick Paul Taylor • June 16, 2020 -
Labs urge CDC to change COVID-19 antibody test guidelines
The trade group for Quest Diagnostics and LabCorp criticized the federal agency's advice against use of serology test results to make decisions about who can return to work.
By Nick Paul Taylor • June 16, 2020 -
Paclitaxel-coated balloon, stent labels in Europe to have mortality warning update
A notice posted by British medical device regulators outlined 12 affected products including Boston Scientific's ELUVIA stent, Cook Medical's Zilver PTX stent, and Medtronic's IN.PACT Admiral balloon.
By Greg Slabodkin • June 15, 2020
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