Research & Development
Pathology & AI
Clinical Chemistry: Page 2
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
Siemens Healthineers unveils in vitro diagnostics systems at AACC 2022
The system, with the capacity to conduct more than 250,000 clinical chemistry tests per year and more than 25,000 immunoassay tests per year, is in development and under review for potential clearance by the U.S. Food and Drug Administration (FDA), the firm said.
July 26, 2022
AACC names new Clinical Chemistry editor in chief
Prior to the editor in chief role, Park served as an associate editor of Clinical Chemistry for seven years and Laboratory Investigation for five years, in addition to serving as an editorial board member and reviewer for numerous other journals, according to a press release from the AACC.
February 21, 2022
20/20 GeneSystems launches clinical lab innovation facility
Called the Clinical Lab Innovation Axcellerator (CLIAx), the laboratory gives diagnostic test developers access to instrumentation and staff. CLIAx comprises 3,000 sq ft of available lab space and testing equipment, including a polymerase chain reaction/molecular assay suite, as well as capabilities in next-generation sequencing, immunoassays, and clinical chemistry, according to 20/20 GeneSystems.
September 28, 2021
What the just-passed CARES Act means for U.S. labs and IVD vendors
CARES stands for the Coronavirus Aid, Relief, and Economic Security Act, and the legislation won the quick approval of the American Association for Clinical Chemistry (AACC). The AACC noted that the CARES Act provides insurance coverage for all COVID-19 diagnostic tests, regardless of whether they are performed under an emergency use authorization from the U.S. Food and Drug Administration (FDA). That was a sticking point in the recently passed Families First Coronavirus Response Act.
March 25, 2020
LabVantage launches lab information system in North America
The LabVantage Medical Suite laboratory information system (LIS) integrates functions from major health and medicine disciplines, including pathology, genomics, microbiology, and clinical chemistry.
March 4, 2020
Beckman Coulter launches DxA 5000 for lab automation in U.S.
The company announced the FDA clearance and the system's availability in the U.S. on October 9, following a decision by the FDA on October 4. Beckman Coulter had showcased the DxA 5000 system, along with other workflow solutions for improving throughput in labs, at the American Association for Clinical Chemistry annual meeting in August and announced its approvals in Europe and China in May.
October 8, 2019
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