FDA Clears Roche CINtec Histology Test
Roche has received FDA marketing clearance for the CINtec Histology test. The p16 biomarker test, when used in conjunction with hematoxylin & eosin (H&E) staining, helps pathologists determine which women should receive treatment for cervical pre-cancer.
The test is a part of Roche’s cervical cancer portfolio, which also includes the Cobas HPV test and the CINtec plus cytology3 test.
FDA Approves Marketing of Alere Reader
Massachusetts–based Alere has won FDA marketing clearance for its Alere Reader, a diagnostic analyzer that can be used in point-of-care and laboratory settings.
The device will be initially available for use with the BinaxNOW Influenza A & B Card 2, with other lateral flow applications and assays to follow. The reformulated test card has achieved Class II designation under the new FDA reclassification requirements.
REVA Receives CE Mark for Its Bioresorbable Coronary Scaffold
REVA Medical has received a CE mark for its Fantom, which is a drug-eluting bioresorbable coronary scaffold. The device is fully visible under x-ray.
The device is an alternative to using metal stents to treat coronary artery disease. Scaffolds restore blood flow, support the artery through the healing process, then disappear from the body over time. The resorption allows the return of natural movement and function of the artery, which is not possible with permanent metal stents.