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FDA Clearance: Page 3
Roche receives FDA clearance for test to accelerate diagnosis of Alzheimer’s
By
Nick Paul Taylor
The new 510(k) clearance covers two tests that run on Roche’s Elecsys immunoassay system. One of the assays, which measures beta-amyloid, was part of the 510(k) clearance that Roche received last year.
June 29, 2023
FDA grants 510(k) clearance, CLIA waiver for BioFire multiplex respiratory panel
By
LabPulse.com staff writers
The FDA reviewed the BioFire test through a dual 510(k) and CLIA waiver pathway, which was designed to speed bringing accurate IVD tests to CLIA-waived settings.
February 7, 2023
FDA greenlights Precision BioLogic chromogenic assay to identify factor IX deficiency
By
LabPulse.com staff writers
The assay is intended for use by clinical labs to identify factor IX deficiency in human plasma and aid in the management of hemophilia B.
January 5, 2023
Roche nabs FDA clearance for two Alzheimer's disease CSF assays
By
LabPulse.com staff writers
The assays measure beta Amyloid (1-42) and Phospho Tau (181P) concentrations in cerebrospinal fluid samples from adults age 55 and older.
December 8, 2022
HemoSonics obtains FDA clearance for whole-blood hemostasis system, cartridge for POC use
By
LabPulse.com staff writers
The system leverages medical-grade ultrasound technology to measure the coagulation properties of a whole blood sample.
November 30, 2022
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
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
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
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
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
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
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
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