Business Insights
Diagnostic Technologies
Diseases
Point-of-Care Testing
Research & Development
Sign In
Policy & Regulation
Trends & Finance
FDA Clearance: Page 7
Beckman Coulter launches DxA 5000 for lab automation in U.S.
By
LabPulse.com staff writers
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
Applied BioCode files 510(k) for respiratory panel
By
LabPulse.com staff writers
The BioCode RPP works with the company's MDx-3000 molecular system. It tests swabs from the back of the nose and throat for 20 common viruses and bacteria, including influenza A, influenza B, respiratory syncytial virus (RSV), and Chlamydia pneumoniae. Up to 188 samples may be processed during an eight-hour shift, according to the company.
September 12, 2019
Binx point-of-care STI testing clears FDA
By
LabPulse.com staff writers
The polymerase chain reaction (PCR) product includes a benchtop instrument with a single-use, assay-specific cartridge. Vaginal swabs may be collected by patients in a clinical setting or by laboratorians, and results are available within half an hour, according to the company.
August 11, 2019
Abbott launches rapid point-of-care blood glucose test
By
LabPulse.com staff writers
The rapid test was cleared by the U.S. Food and Drug Administration (FDA) in May 2018 for use with the company's Afinion AS100 analyzer to measure HbA1c, diagnose diabetes, and assess risk for developing the condition. It received clearance from the agency for use with the company's Afinion 2 multiassay analyzer in November 2018.
June 16, 2019
FDA clears 1st extragenital STD tests
By
LabPulse.com staff writers
The tests are designed to detect the presence of the bacteria Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) with extragenital specimens acquired via the throat and rectum. Previously, the tests were cleared only for use with urine, vaginal, and endocervical samples.
May 22, 2019
Babesiosis testing makes strides with FDA clearances
By
Bruce Carlson
Ticks are arachnids: Small crawling bugs with eight legs that are related to spiders and mites. They are also parasites and feed on the blood of humans and animals. Ticks are vectors due to their disease transmission capability.
May 14, 2019
Smaller labs eye digital pathology options to improve workflow
By
Joseph Constance
The first digital pathology system for primary diagnostic use became available when Philips Healthcare received U.S. Food and Drug Administration (FDA) clearance in 2017 for its IntelliSite Pathology Solution. As this and other digital pathology products become available, labs face the dilemma of managing a transition that offers higher efficiency but at the price of a major capital investment.
May 8, 2019
Previous Page
Page 7 of 7