FDA: Page 54
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FDA tracks impact of COVID-19 mutations on test performance
The agency is concerned existing tests might miss new variants, Tim Stenzel, director of the FDA's Office of In Vitro Diagnostics and Radiological Health, said. Thermo Fisher's Taqpath COVID-19 assay may detect the U.K. version.
By Greg Slabodkin • Jan. 7, 2021 -
FDA finalizes speedier medical device pathway alternative to breakthrough status
Final guidance for the voluntary Safer Technologies Program features changes to draft sections criticized by AdvaMed, specifically what qualifies as a "significant" improvement to patient safety.
By Nick Paul Taylor • Jan. 6, 2021 -
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 -
FDA flags false negative risk of startup Curative's COVID-19 test
The Los Angeles-based firm was founded in January 2020 to focus on sepsis but has since pivoted to focus on coronavirus. Justin Mateen, founder of dating app Tinder, is its lead investor, according to Crunchbase.
By Nick Paul Taylor • Jan. 5, 2021 -
Hospitals lose another attempt to stave off price transparency
A judge wrote that the American Hospital Association's arguments, including that some rates are unknowable, "miss the mark." Facilities are now set to disclose base rates for items and services as of Jan. 1.
By Samantha Liss • Jan. 4, 2021 -
Brexit deal creates regulatory barriers to UK-EU medical device trade
The new arrangement lacks provisions for the mutual recognition of standards, forcing products made in the U.K. to undergo an extra certification step to enter the EU market.
By Nick Paul Taylor • Jan. 4, 2021 -
FDA 2020 recall roundup: A rough year for infusion pumps
The agency listed a total of nine entries for recalls of infusion pumps or components and one update of an earlier action, for models made by Baxter, BD, CME America and Smiths Medical. BD's Alaris line accounted for half.
By Susan Kelly • Dec. 23, 2020 -
Permission granted by Quidel Corporation
Quidel gets EUA to rival Abbott's rapid, point-of-care antigen test
The pregnancy-like diagnostic is up to five minutes faster than the big medtech's equivalent test and, based on current data, may be more sensitive.
By Nick Paul Taylor • Dec. 22, 2020 -
Provider-friendly surprise billing fix, more funds for hospitals in year-end spending bill
The sweeping legislation includes billions for state and local governments, hospitals and healthcare providers, and to help establish a national COVID-19 testing and contact tracing system.
By Rebecca Pifer • Dec. 21, 2020 -
Notified bodies warn MDR certification bottleneck could lead to medical device shortages
With more than 7,000 certificates set to expire in 2024, Team-NB wants the European Union to act now by allowing remote audits under the Medical Device Regulation.
By Nick Paul Taylor • Dec. 21, 2020 -
Medtronic, GE, Philips embrace AI amid regulatory limbo around algorithms
The focus comes as FDA action seems stalled. It's been a year and a half since the agency issued a discussion paper on its proposed regulatory framework for machine learning-based software as a medical device.
By Greg Slabodkin • Dec. 21, 2020 -
Moderna's first FDA clearance brings the US a second coronavirus vaccine
The FDA's emergency authorization of the biotech's shot bolsters an immunization campaign in the U.S. that's just beginning.
By Ben Fidler • Dec. 18, 2020 -
FDA panel endorses Moderna's coronavirus vaccine
A group of independent experts supported use of the biotech's shot, which is likely to receive an emergency authorization from the agency within days.
By Ned Pagliarulo • Updated Dec. 17, 2020 -
Hospital costs drove 2019 health spending, CMS analysis finds
Although health system prices grew at a slower rate than a year earlier, non-price factors, which include "the use and intensity of goods and services," grew 4.2%, compared with 1.8% in 2018, the report published in Health Affairs found.
By Hailey Mensik • Dec. 17, 2020 -
Courtesy of Miach Orthopaedics
NFL player-backed implant to fix ACL tears gets FDA De Novo
Miach Orthopaedics' synthetic device, made from bovine collagen, offers an alternative to traditional reconstruction for one of the most common knee injuries in the U.S.
By Greg Slabodkin • Dec. 17, 2020 -
Abbott antigen test gets FDA nod as first at-home, virtually guided COVID-19 diagnostic
BinaxNOW requires a prescription and a telehealth service to take users through collection. However, public health experts question why prescriptions are being required at all for such tests.
By Greg Slabodkin • Dec. 17, 2020 -
At FDA's request, Penumbra recalls catheter device after 14 patient deaths
"There's no way around the fact that this is a disappointing blow to the company's credibility given the positive commentary we've received from the company since the initial July warning notice," J.P. Morgan analysts wrote.
By Ricky Zipp • Dec. 17, 2020 -
Stryker, Zimmer shift strategies to capitalize on growing ASC market
Now that Medicare has caught up to private payers opening up coverage policies, experts see procedure migration away from hospitals accelerating. Pricing pressure is a risk, though.
By Ricky Zipp • Dec. 16, 2020 -
Breakthrough designations go to renal denervation devices in latest FDA batch
ReCor and SoniVie disclosed the regulatory privileges within a day of each other, boosting their efforts to enter a market targeted by Medtronic.
By Nick Paul Taylor • Dec. 16, 2020 -
FDA lays out alternative 510(k) path criteria for 3 device types
The agency finalized guidance documents covering several product categories — spinal plating systems, orthopaedic bone screws and magnetic resonance coils — as it pushes forward with its Safety and Performance Based Pathway.
By Susan Kelly • Dec. 15, 2020 -
FDA grants EUA for first fully at-home COVID-19 test without a prescription
The rapid antigen test from Australian company Ellume will be available over the counter for people with or without symptoms and delivers results in about 20 minutes.
By Susan Kelly • Dec. 15, 2020 -
Deep Dive
MDR-IVDR bottleneck persists as EU launches 1st Eudamed module
"Very few notified bodies at this moment in time are taking new products on under the old directive, because a medical device doesn't just get certified overnight," an official at Ireland's National Standards Authority said.
By Nicholas Wallace • Dec. 14, 2020 -
Master Sgt. Hecht, Matt. (2020). [Photograph]. Retrieved from Flickr.
Trump admin defends national stockpile as PPE, equipment shortages persist
"We’re not the Walmart that you can walk into on a daily basis to get your standard needs to treat patients and get PPE. We are a 911 response team," an HHS official said, adding the stockpile hasn't denied a single state request.
By Rebecca Pifer • Dec. 14, 2020 -
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 -
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 • Dec. 11, 2020
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