Diagnostics: Page 20
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Watchdog faults FDA for rushing COVID-19 tests to market by easing emergency use rules
HHS’ Office of Inspector General found that by loosening emergency use authorization requirements to bring COVID-19 tests to market faster, the agency allowed inaccurate tests to be distributed.
By Elise Reuter • Sept. 21, 2022 -
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Racial bias in pulse oximeters to be subject of FDA panel
The design of the ubiquitous fingertip monitors has inadvertently caused false blood oxygen readings in darker-skinned patients, a problem the FDA hopes to fix.
By Peter Green • Sept. 16, 2022 -
Explore the Trendline➔
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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 -
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FDA eases authorization policy for monkeypox tests as lab group points to ‘lessons learned’ from Covid-19
Laboratory group says new agency guidance that offers templates and more time to submit data should help test developers.
By Elise Reuter • Sept. 15, 2022 -
Spencer Platt via Getty Images
Medtech firms increasingly positive about future as staffing, inflation pressures ease, say RBC analysts
Hospital staffing and supply chain issues are expected to improve, according to comments from Boston Scientific, J&J, Medtronic, and others.
By Nick Paul Taylor • Sept. 15, 2022 -
Courtesy of Grail
Amid merger turmoil, Illumina’s Grail unit reports downturn in accuracy of blood-based cancer test
New data on Grail’s cancer screening test could weaken the company’s competitive standing against rivals Guardant Health, Exact Sciences and Freenome.
By Nick Paul Taylor • Sept. 12, 2022 -
Permission granted by Becton Dickinson
Q&AFriday Q&A: BD Life Sciences President Dave Hickey shares plans for expanded testing ‘menu’
Demand for COVID-19 tests may be slowing, but more laboratories have installed testing systems during the pandemic, the executive says.
By Elise Reuter • Sept. 8, 2022 -
Pablo Blazquez Dominguez via Getty Images
FDA issues first EUA for monkeypox test
Quest Diagnostics' PCR test for monkeypox received emergency use authorization after the FDA issued guidance on how it will evaluate the tests.
By Elise Reuter • Sept. 8, 2022 -
Karen Ducey via Getty Images
HHS will allow EUAs for monkeypox tests to increase access in the US
The move follows the declaration of a public health emergency for the monkeypox outbreak on Aug. 4.
By Ricky Zipp • Sept. 7, 2022 -
Courtesy of Illumina
Illumina’s hold on Grail depends now on separate appeals in US, Europe
Even as it plans to appeal a European Commission decision and the FTC plans to appeal a U.S. ruling, Illumina say it’s preparing for ‘strategic alternatives’ to its acquisition of early cancer detection firm Grail.
By Elise Reuter • Updated Sept. 7, 2022 -
Screenshot from WKTU TV. (2019). [Photo]. Retrieved from WKTU TV.
Federal jury convicts medtech executive in $77M blood testing kickback case
Arrayit President Mark Schena’s conviction on nine federal charges carries a maximum sentence of more than 100 years in prison.
By Nick Paul Taylor • Sept. 6, 2022 -
PeopleImages/Getty via Getty Images
Machine learning algorithm predicts unfavorable labor outcomes for mothers in retrospective study
The researchers plan to validate the model using Mayo Clinic patients before deploying it prospectively in maternity wards.
By Nick Paul Taylor • Sept. 6, 2022 -
Phil Walter via Getty Images
Another COVID-19 test supplier ordered by FDA to take its products off the market
USA Medical has been warned by FDA that its rapid antigen tests had not been cleared or authorized by the agency.
By Elise Reuter • Sept. 1, 2022 -
Karen Ducey via Getty Images
Dispute over monkeypox test reimbursement rates may hurt effort to halt disease’s spread: experts
The CMS says regional administrators can set prices, even as lab group warns fees are too low for commercial firms to conduct testing.
By Elise Reuter • Aug. 31, 2022 -
Courtesy of Illumina
Illumina opens first manufacturing facility in China to supply gene sequencing products
The company aims to produce all gene sequencing instruments and consumables locally within five years in a bid to expand its presence in the growing Chinese market.
By Nick Paul Taylor • Aug. 31, 2022 -
Retrieved from Olympus on August 30, 2022
Olympus to sell microscope unit for $3.1B as it bolsters focus on medical technology
Bain Capital has taken the other side of the deal, paying $3.1 billion for a business it said is “at the frontier of digital optical technology in life sciences and industrial end markets.”
By Nick Paul Taylor • Aug. 30, 2022 -
Retrieved from NJ Medical School Website on August 25, 2022
Labcorp adds to hospital lab buying streak with New Jersey acquisition
The purchase comes as hospitals work to trim costs and testing firms seek stable revenue streams as COVID-19 testing winds down.
By Peter Green , Rebecca Pifer • Aug. 25, 2022 -
Karen Ducey/Getty Images via Getty Images
Lab group ACLA warns ‘inadequate’ payment rates may limit access to monkeypox testing
The trade group urged the CMS to ensure monkeypox testing claims are paid at its “reasonably derived” recommended rate to ensure access to testing.
By Nick Paul Taylor • Aug. 23, 2022 -
Courtesy of Abbott
Abbott blood test predicts death, unfavorable outcomes in traumatic brain injury patients, study finds
Abbott is pursuing FDA clearance for the breakthrough-designated TBI test to expand access to a diagnostic that predicted death and severe disability.
By Nick Paul Taylor • Aug. 12, 2022 -
Karen Ducey/Getty Images via Getty Images
As monkeypox cases increase, disease experts lament lack of testing access
“It’s the same problem that happened with COVID-19. This is exactly identical,” said Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security in Baltimore.
By Elise Reuter • Aug. 10, 2022 -
Spencer Platt/Getty Images via Getty Images
Roundup: Medical device industry confident it can ride out recession, wary of slowing capital sales
While companies may weather a recession, they still face challenges like hospital staffing shortages, supply chain disruption and inflation, RBC Capital Markets analysts wrote.
By Nick Paul Taylor • Updated Aug. 10, 2022 -
Naomi Eide/MedTech Dive
Senate passes $740B bill to lower healthcare costs after months of wrangling
While Republicans successfully challenged a planned $35 insulin price ceiling for patients on private insurance, the law still has implications for makers of diabetes devices.
By Nick Paul Taylor • Aug. 8, 2022 -
Sarah Silbiger via Getty Images
FDA’s breakthrough device designations poised for another record year
At the midpoint of the year, the FDA had granted 129 designations, suggesting it will break the previous full-year record of 206.
By Nick Paul Taylor • Aug. 8, 2022 -
Peter S Green/MedTech Dive
QuidelOrtho reports 37.5% sales growth in first quarter since $6B merger
The testing firm is increasing sales after Quidel merged with Ortho, opening opportunities to cut costs and increase point-of-care and molecular diagnostics revenue.
By Nick Paul Taylor • Aug. 5, 2022 -
Pablo Blazquez Dominguez via Getty Images
Biden administration declares monkeypox a public health emergency
Federal health officials said Thursday that U.S. monkeypox testing capacity is at about 80,000 tests per week, although only 10% of capacity is currently being used.
By Ricky Zipp • Aug. 4, 2022 -
Permission granted by Becton Dickinson
BD’s base business growth in Q3 offset by drop in COVID-19 testing
The company reported a year-over-year drop of about $224 million in COVID-19 testing revenue compared to 2021, with the testing slowdown expected to continue.
By Ricky Zipp • Aug. 4, 2022
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