FDA Approves Roche’s EGFR Mutation Test June 2, 2016 The test is intended to accompany lung cancer therapy Tarceva. Read More
Chinese FDA Approves Tissuemed’s TissuePatch June 1, 2016 The company says TissuePatch is the first synthetic sealant to nab CFDA approval. Read More
Pinnacle Spine Group Introduces InFill ALIF Interbody Device June 1, 2016 The device is designed to enhance wall thickness and graft chamber. Read More
Luminex Nabs CE-IVD Mark for ARIES Flu A/B & RSV Assay June 1, 2016 The test is designed for use on the company’s ARIES System. Read More
BioVentrix Secures FDA IDE Approval to Begin Clinical Trial June 1, 2016 The trial involves 120 patients at up to 20 sites nationwide. Read More
FDA Approves Blue Earth Diagnostics’ Axumin Injection June 1, 2016 Axumin is the first product commercialized by Blue Earth Diagnostics. Read More
EndoGastric Solutions Launches EsophyX Z System May 31, 2016 The first procedure using the device was performed at UC Irvine Health in Irvine, Calif. Read More
Vigilant Biosciences Introduces OncAlert Labs OraMark Test May 31, 2016 The test will be available to health care providers in the U.S. during the latter half of the year. Read More
Cordis Recalls Precise Pro RX System May 31, 2016 The device is intended for use in patients with stenotic lesions of the carotid artery. Read More
Biocept Launches PD-L1 Liquid Biopsy Test May 31, 2016 The test is designed for use on the company’s Target Selector platform. Read More
Roche Launches CoaguChek INRange System May 31, 2016 The system permits patients to monitor their coagulation status and Vitamin K Antagonist therapy. Read More
New Version of ISO 13485 Underscores Risk Management, Usability May 27, 2016 Risk management and usability are some of the highlights in the new version of ISO 13485, which was revised earlier this year. Read More