Hitachi
Hitachi High-Tech, Gencurix Partner to Bring Cancer MDx to Japanese Market
The companies aim to serve cancer patients in Japan, and eventually other markets, with genomic testing that can better personalize their treatment.
Ortho Clinical Diagnostics, Siemens Healthineers, Roche, and Others Obtain FDA Clearances in October
The FDA granted clearance to Roche for use of its Cobas Cdiff nucleic acid test, which detects the toxin B gene running on the firm's Liat point-of-care instrument.
Siemens Healthineers, Beckman Coulter, Becton Dickinson, Others Receive FDA Clearances in March
Beckman Coulter got regulatory clearance for three in vitro diagnostic products, including its DxH 520 hematology analyzer for low-volume clinical labs.
FDA Clears Hitachi Chemical Diagnostics Allergy Testing Instrument
The Optigen AP 3600 can process up to 100 panels, or as many as 3,600 individual allergen results, in one day, and allows for true walk-away time, the firm said.
The company is now commencing a trial of the test platform in 250 patients to generate more data while it considers how to best commercialize it.