Policy & Regulation
-
In last-minute push, Trump admin rolls back Stark, anti-kickback rules
The final regs are slated to take effect Jan. 19, one day before President-elect Joe Biden is inaugurated. The new administration could change them but experts called that unlikely.
By Rebecca Pifer • Nov. 23, 2020 -
Getty Images
NEJM commentary calls for 510(k)s for OTC hearing aids after senators pan FDA delay to rule
While critics of the delay acknowledged FDA's coronavirus-related workload this year, the agency has failed to come through with the draft regulation required by a 2017 law.
By Nick Paul Taylor • Nov. 23, 2020 -
MedTech Europe backs proposed EU Health Union but flags potential hangups
The trade group fears moving responsibility for administering the IVDR and MDR expert panels to the European Medicines Agency could slow deployment.
By Nick Paul Taylor • Nov. 20, 2020 -
Notified bodies report early success with remote audits but challenges remain
While there have been benefits to going remote during the pandemic, 57% of those polled by a European trade group say they take longer than on-site assessments and most encounter problems due to poor network connections.
By Nick Paul Taylor • Nov. 20, 2020 -
HHS piloting Cue's NBA-tested rapid COVID-19 diagnostic in 5 states
Unlike lab-based molecular tests, which can take two to three days to turn around, Cue Health's point-of-care molecular test generates results in about 20 minutes.
By Maria Rachal • Nov. 19, 2020 -
Master Sgt. Hecht, Matt. (2020). [Photograph]. Retrieved from Flickr.
Health insurers, labs point fingers over COVID-19 test coverage and prices
An AHIP study of claims data is the latest volley in a debate about who ultimately foots the bill for coronavirus diagnostics. ACLA blames "murky" tri-agency guidance for coverage denials and high out-of-pocket costs.
By Nick Paul Taylor , Greg Slabodkin • Nov. 19, 2020 -
Jacob Bell
FDA OKs first fully at-home COVID-19 test as US cases surge
An emergency use authorization to biotech Lucira Health comes as some experts say the tests could help significantly boost capacity. Others say that's a long way off, and call for more guidance from regulators on proper use.
By Greg Slabodkin • Nov. 18, 2020 -
"White House Press Briefing". Retrieved from The White House.
In shift, FDA ordered to provide 'timely' EUA reviews for COVID-19 lab developed tests
Testing czar Brett Giroir has reversed FDA's decision to no longer review emergency use authorization requests for LDTs so that university labs can secure EUAs and get liability protection under the PREP Act.
By Greg Slabodkin • Nov. 17, 2020 -
Jacob Bell / BioPharma Dive
FDA draft guidance expands electromagnetic compatibility advice for medtechs
A new document builds on a very brief final guidance from 2016, as the agency looks to gather the right information on how devices function in intended electromagnetic environments.
By Nick Paul Taylor • Nov. 17, 2020 -
EU regulators provide 7 rules for classifying diagnostics under IVDR
The European Commission's Medical Device Coordination Group placed IVDs into different risk categories based on how they will be used. Only one class can be self-certified.
By Nick Paul Taylor • Nov. 16, 2020 -
"State Public Health Laboratory in Exton Tests for COVID-19" by Governor Tom Wolf is licensed under CC BY 2.0
Labs face COVID-19 surges, warn of test result delays as CMS pay cuts loom
The American Clinical Laboratory Association sounded an alarm over nationwide capacity constraints, which may increase average time to results.
By Maria Rachal • Nov. 13, 2020 -
Getty
BD's Alaris infusion pumps flagged for cybersecurity vulnerability
The Department of Homeland Security alert scored the issue 6.5 out of 10 and said a successful attack that exploited the weakness could force operators to manually program the pumps.
By Nick Paul Taylor • Nov. 13, 2020 -
Kendall Davis/Industry Dive/MedTech Dive, data from Marc Nozell
3 ways Biden's COVID-19 approach could impact medtech
A new administration — regardless of who's in power — means device makers can anticipate shifts at key government agencies like the FDA.
By Maria Rachal , Greg Slabodkin • Nov. 12, 2020 -
Courtesy of Qiagen
Qiagen seeks EUA for COVID-19 antigen test aiming for positive results in 2 minutes
The company claims 90% sensitivity, whereas other antigen tests sold by Abbott, Roche and Quidel have reported sensitivities of around 97%.
By Nick Paul Taylor • Nov. 12, 2020 -
Remote trials, US-Israel device partnership among pitches in FDA, HHS funding bills
The Senate appropriations committee released a series of budget proposals for fiscal 2021. FDA's device center is slated for a 5% funding increase, making it one of the only centers set to receive less than requested.
By Nick Paul Taylor • Nov. 11, 2020 -
UK fleshes out post-Brexit approach to regional medical device marking
The Medicines and Healthcare products Regulatory Agency further clarified conformity marking as medtechs prepare for the transition period to end.
By Nick Paul Taylor • Nov. 11, 2020 -
from Solar Power International
Top picks for who could run HHS, CMS under Biden
Former Obama adviser and ACA architect Ezekiel Emanuel as well as high-profile state officials like New Mexico Governor Michelle Lujan Grisham are among those considered likely advisers.
By Rebecca Pifer • Nov. 10, 2020 -
"White House Press Briefing". Retrieved from The White House.
Abbott COVID-19 tests at center of squabble between Trump administration, states
HHS testing czar Brett Giroir on Monday said the government is halting the antigen test shipments to eight states until those already sent are distributed and used. At least one state pushed back on his assertions.
By Greg Slabodkin • Nov. 10, 2020 -
The image by Gage Skidmore is licensed under CC BY-SA 2.0
Biden transition team names COVID-19 advisers, seeks dramatic testing scale-up with federal approach
The president-elect calls for doubling drive-through test sites and increasing capacity by "orders of magnitude" through investing in rapid at-home tests. The transition team has already called in help from former FDA and BARDA heads.
By Greg Slabodkin • Nov. 09, 2020 -
"200323-Z-IB607-0016" by New Jersey National Guard is licensed under CC BY-ND 2.0
GenScript wins 1st FDA nod to test for antibodies that could neutralize COVID-19
The Hong Kong-listed biotech's offering differs from earlier EUAs for serology tests from Abbott, Roche and Siemens Healthineers that only screen for antibodies that do not necessarily cut viral infection.
By Susan Kelly • Nov. 09, 2020 -
Courtesy of Nightware
FDA greenlights digital therapeutic for Apple Watch to quell PTSD nightmares
The device, from Minneapolis-based startup Nightware, monitors heart rate and body movement data to best deliver vibrations that interrupt a nightmare without waking the person sleeping.
By Susan Kelly • Nov. 09, 2020 -
Even if Biden wins, divided Congress stifles chance for more progressive health policies
Results of the election are not final and may be uncertain for weeks, but the most likely scenario points to mostly incremental change, a positive for many parts of the healthcare sector.
By Shannon Muchmore • Nov. 05, 2020 -
Jacob Bell
FDA warns of COVID-19 antigen test false positives as report flags Quidel on accuracy
The agency alert, prompted by reports from nursing homes and other settings, comes a day after data emerged raising concerns about the ability of a Quidel test to detect asymptomatic cases.
By Nick Paul Taylor • Nov. 04, 2020 -
McKnight
MedPAC pans CMS idea to lean on commercial payers for Medicare coverage decisions
The advisory group warned against threats to transparency and rigor in response to a proposed rule defining the term "reasonable and necessary" and adding a faster coverage pathway for FDA-designated breakthrough devices.
By Susan Kelly • Nov. 03, 2020 -
Permission granted by Baxter
CMS finalizes rejection of Baxter, Outset dialysis device add-on payments
The broader, now final, ESRD rule is meant to support use of equipment and supplies for at-home dialysis treatment.
By Nick Paul Taylor • UPDATED: Nov. 3, 2020 at 9:52 a.m.
