FDA: Page 55
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Biden appoints Janet Woodcock as acting FDA chief, plans COVID-19 testing board
The longtime agency staffer is reportedly being considered to permanently fill the role. The president also named acting directors for HHS and CMS.
By Shannon Muchmore • Jan. 21, 2021 -
Courtesy of Abbott Labs
Abbott antigen test misses two-thirds of COVID-19 asymptomatic cases: CDC
Compared to gold standard PCR tests, the company's point-of-care BinaxNOW diagnostic had a 35.8% sensitivity when used to analyze samples taken from individuals without symptoms, according to the agency.
By Nick Paul Taylor • Jan. 21, 2021 -
Explore the Trendline➔
Sara Silbiger via Getty Images
TrendlineTop 5 stories from MedTech Dive
From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.
By MedTech Dive staff -
FDA breakthrough nods go to Alzheimer's devices, cardiovascular products
Cognito and Boston Scientific-backed Functional Neuromodulation picked up agency designations, positioning them for speedy reviews as they work to get their Alzheimer offerings to market.
By Nick Paul Taylor • Jan. 20, 2021 -
CMS expands transcatheter mitral coverage, boosting Abbott's MitraClip device
Wall Street analysts said the national coverage determination could triple the patient base eligible for Abbott's MitraClip device, adding fuel to a growing and under-penetrated market.
By Ricky Zipp • Jan. 20, 2021 -
CMS rejects 1st colorectal cancer blood test, tweaks path for Exact, Guardant and others
The agency removed one of the criteria needed to secure Medicare coverage but still shunned Epigenomics' diagnostic. Rivals have versions in development.
By Nick Paul Taylor • Jan. 20, 2021 -
MedTech Europe calls for EU to retain support for digital health post-pandemic
The industry wants reimbursement changes and other measures to make digital health permanent.
By Nick Paul Taylor • Jan. 19, 2021 -
Abbott, Quidel tout big COVID-19 testing year despite vaccine rollout: JPM21
"I don't see COVID just simply going away, but I do see it looking more like a flu-like seasonal test. And if you think about it globally, it's a pretty significant amount of volume," Abbott CEO Robert Ford said at J.P. Morgan's conference.
By Greg Slabodkin • Jan. 15, 2021 -
Google calls Fitbit acquisition complete despite ongoing DOJ review
The search giant closed the deal because the department's 14-month investigation period expired without any objection. However, DOJ could still sue to unwind the buy.
By Rebecca Pifer • Jan. 14, 2021 -
Yujin Kim/MedTech Dive
Pandemic propels health systems to mull insurer acquisitions, partnerships: JPM21
Advocate Aurora CEO Jim Skogsbergh said "partnering for health plan capability is going to be critical to our success."
By Samantha Liss • Jan. 14, 2021 -
FDA issues action plan for regulating AI in medical devices
The proposal brings the agency a step closer to draft guidance for regulating the fast-evolving field of artificial intelligence and machine learning-based software in medical devices.
By Susan Kelly • Jan. 13, 2021 -
CMS breakthrough rule called tailwind for Abbott, J&J and Medtronic
The policy gives developers of FDA-designated breakthrough products coverage for Medicare's 60 million beneficiaries on the day of approval.
By Nick Paul Taylor • Jan. 13, 2021 -
In medtech win, MDR-IVDR remote audits OK'd amid pandemic pressures
An official for MedTech Europe, which pushed for flexibility ahead of new medical device rules set to kick in later this year, called the move "significant and positive."
By Nick Paul Taylor • Jan. 12, 2021 -
"State Capitol Building, USA, California, Sacramento" [Photograph]. Retrieved from Pixy.
California proposes expanding Medicaid coverage of continuous glucose monitors
The budget proposal seeks to increase access to CGMs among adults with Type 1 diabetes covered by the state's Medicaid program Medi-Cal. Abbott, Dexcom, Medtronic and Senseonics compete for the U.S. CGM market.
By Nick Paul Taylor • Jan. 11, 2021 -
Jacob Bell/MedTech Dive
FDA flags COVID-19 false negative risk from virus variant of Thermo Fisher, Applied DNA and Mesa tests
Sensitivity may be affected by emerging forms of the virus, though the agency said "the impact does not appear to be significant." In fact, the tests may help to spot where a fast-spreading variant is prevalent.
By Nick Paul Taylor • Jan. 11, 2021 -
"White House Press Briefing". Retrieved from The White House.
HHS allocates $300M for Abbott COVID-19 rapid tests or 'equivalent' testing tech
The agency has yet to decide if it will purchase Abbott's or a similar diagnostic from a rival, Assistant Secretary for Health Brett Giroir said Thursday.
By Greg Slabodkin • Jan. 8, 2021 -
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 -
Jacob Bell/MedTech Dive
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 -
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 -
Jacob Bell/MedTech Dive
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
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