Diagnostics: Page 21
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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 -
Explore the Trendline➔
Permission granted by Boston Scientific
TrendlineNew medical devices are reshaping the medtech industry
From pulsed field ablation devices to glucose sensors and surgical robotics, new medical technologies are transforming patient care and how people manage their health.
By MedTech Dive staff -
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 -
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 -
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 -
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 -
Retrieved from Siemsens Website on July 01, 2022
Siemens Healthineers stumbles as lockdowns, falling COVID-19 sales and rising costs hit business
Lockdowns in China caused a steep decline in equipment orders and a big setback to the firm’s core diagnostic business, even as the company expects to meet full year revenue targets.
By Nick Paul Taylor • Aug. 3, 2022 -
Ethan Miller via Getty Images
North American Diagnostics latest to recall COVID-19 tests, gets Class I label from FDA
The recall adds to a list of medtech firms that have been forced to withdraw illegally distributed COVID-19 tests, amid concerns they could yield false results.
By Ricky Zipp • Aug. 2, 2022 -
Illumina vows to fight EU efforts to block $8B Grail merger
Illumina acquired the liquid biopsy company in 2021, despite pending anti-competitiveness investigations on both sides of the Atlantic.
By Elise Reuter • Updated Aug. 2, 2022 -
Retrieved from Medridien Bioscience website on August 01, 2022
FDA reauthorizes Meridian’s COVID-19 test after changes to enable omicron detection
The renewed emergency use authorization comes as SD Biosensor works to close its $1.53 billion takeover of Meridian.
By Nick Paul Taylor • Aug. 1, 2022 -
Chip Somodevilla/Getty via Getty Images
Core diagnostic growth offsets falling COVID-19 sales at Hologic, Thermo Fisher, Qiagen
Rising demand for core diagnostics offset better-than-feared declines in COVID-19 test sales, shedding light on the companies’ post-pandemic futures.
By Nick Paul Taylor • July 29, 2022 -
Courtesy of Labcorp
Labcorp lowers forecast after Q2 slowdown, will spin off drug development unit
A drop in COVID-19 testing contributed to the company’s second quarter decline, while its base business grew by 1.2% compared to last year.
By Ricky Zipp • July 28, 2022
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