Torax’s Linx System Gains FDA Nod June 24, 2015 The MRI-conditional, reflux management system is indicated for patients with gastro-esophageal reflux disease. Read More
Siemens’ HIV Combo Assay Wins FDA Nod June 23, 2015 The assay detects an HIV viral protein and antibodies generated in response to the infection. Read More
FDA OKs Tongue Signals Device for the Blind June 18, 2015 The product helps people process visual images. Read More
Sapien 3 Artificial Heart Valve Nabs FDA Nod June 18, 2015 The third generation product features a skirt at the base of the valve meant to minimize leakage around the device. Read More
Alcon Secures EU Approval for New Lens June 17, 2015 The AcrySof IQ PanOptix is indicated for adult patients undergoing cataract surgery. Read More
Zecotek Touts PET Crystals Trial Results June 16, 2015 In CERN-conducted tests, the crystals showed more precise coincident time resolution than competitors. Read More
Breathe Technologies Wins FDA Nod for Life2000 June 16, 2015 The ventilation system’s approval marks the company’s first FDA-cleared device for life-support patients. Read More
FH Ortho Gains FDA 510(k) Clearance for Orthopedic Arthrodesis Nail June 16, 2015 The Calcanail system is indicated for heal fractures and rear foot fusion surgery. Read More
Ventana Snags FDA Approval for ALK Companion Diagnostic Assay June 16, 2015 The test is indicated as an aid to patient identification for Pfizer’s Xalkori in the treatment of non-small cell lung cancer. Read More
Aesculap’s activL Artificial Disc Wins FDA Approval June 15, 2015 The device is meant as an alternative to spinal fusion surgery. Read More
Merck Secures Gavi and Geri CE Mark Approval June 15, 2015 Both products feature fertility treatment innovations, company says. Read More
Sanovas’ PulmoVia Snags FDA 510(k) Clearance June 15, 2015 The device is engineered to improve diagnostic and therapeutic lung treatment. Read More