FDA Clearance: Page 3

Empatica receives FDA clearance for digital biomarker platform, closes Series B financing
By LabPulse.com staff writers
The platform is used to gather and analyze physiological data for clinical trials evaluating new therapeutics. Empatica is collaborating with researchers on digital biomarkers for use as endpoints.
November 23, 2022
Computer Woman Ai Social
DiaSorin congenital CMV direct assay receives FDA 510(k) clearance
By LabPulse.com staff writers
The molecular diagnostic test enables direct detection of cytomegalovirus (CMV) DNA in saliva swab and urine specimens from babies 21 days old or younger.
November 9, 2022
Baby Bottle Social
FDA clears Baebies disposable G6PD test
By LabPulse.com staff writers
The rapid point-of-care test uses a drop of blood to detect glucose-6-phosphate dehydrogenase (G6PD) deficiency, which causes hemolytic anemia.
November 9, 2022
Hospital Baby Nurse Social
Abbott nabs first FDA EUA for a commercial test kit to detect monkeypox
Abbott Molecular received an EUA for an RT-PCR test intended to detect monkeypox DNA using lesion swab specimens from individuals suspected of monkeypox virus infection.
October 7, 2022
Infectious Diseases Research Social
Boston Cell Standards nabs FDA clearance for IHC test panel to evaluate breast cancers
By LabPulse.com staff writers
Boston Cell Standards on Thursday announced that the FDA has granted 510(k) clearance for the company’s IHControls panel for evaluating breast cancers.
October 6, 2022
Breast Cancer
Roche nabs FDA clearance for low- to mid-volume lab system
By LabPulse.com staff writers
A member of the Cobas family of serum-work-area solutions, the system combines clinical chemistry, immunoassay, and ion-selective electrode diagnostic testing onto a single platform to optimize space and resources for low- to mid-volume labs. It automates manual tasks, improves productivity, and supports fast delivery of patient results, Roche said.
September 18, 2022
2022 09 19 20 10 3970 20191120 Roche Pure Links 5 Us 400
Week in Review: Multicancer early detection at ESMO, DiaSorin nabs FDA clearance for COVID-19 kit, IVD industry urges Congress to enact SALSA, and more
By Leo O'Connor
Dear LabPulse.com member,
September 14, 2022
Tasso nabs FDA clearance for blood collection lancet
By LabPulse.com staff writers
The company will now be able to sell the device to more pharmaceutical companies, healthcare organizations, and academic institutions across the U.S.
September 13, 2022
2022 06 09 18 00 5852 Lab Blood Samples 400
Cue Health requests FDA de novo clearance for at-home flu test
By LabPulse.com staff writers
Clearance would permit the test to be used at home and elsewhere at the point-of-care (POC).
September 1, 2022
2022 09 02 19 52 9683 Flu Season Ahead 400
Abionic nabs IVDR certification for sepsis test
By LabPulse.com staff writers
The device detects pancreatic stone protein, an early marker for sepsis, allowing for its identification in about five minutes, Abionic said.
August 8, 2022
2020 06 19 20 57 0712 Sepsis Bacteria 400
Video from AACC: Cytovale immune-response test for sepsis
By Leo O'Connor
The San Francisco-based startup has submitted an application to the U.S. Food and Drug Administration (FDA) for clearance of the system and test, which aims to help emergency departments to more effectively and quickly triage patients.
July 28, 2022
2022 07 29 16 04 7496 Shah 400
FDA clears Angle’s Parsortix breast cancer system
By LabPulse.com staff writers
The FDA clearance is the first FDA product clearance to harvest cancer cells from a blood sample for subsequent analysis. This offers the prospect of a new era of personalized cancer care, according to the company.
July 27, 2022
2022 07 28 17 23 1016 Breast Biopsy Mammotome 400
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