Business Insights
Diagnostic Technologies
Diseases
Point-of-Care Testing
Research & Development
Sign In
Policy & Regulation
Trends & Finance
FDA Clearance
FDA starts one-year pilot program to tackle risks of lab developed oncology tests
The goal is to provide laboratories with information to support development of LDTs for specific cancer biomarkers, to facilitate “better and more consistent” testing and, by extension, “better drug selection and improved care for patients with cancer."
July 21, 2023
Roche receives FDA clearance for test to accelerate diagnosis of Alzheimer’s
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
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
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
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
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
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
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
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
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
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
Page 1 of 5
Next Page
