BioFire Gets FDA Clearance, CE Mark for FilmArray 2.0 February 27, 2015 The new system delivers higher throughput and single database management. Read More
FDA Allows Emergency Use of Corgenix Rapid Ebola Test February 27, 2015 The test can detect the Ebola Zaire virus in 15 to 25 minutes. Read More
Masimo’s PVI Technology Cleared for South Korean Market February 26, 2015 PVI technology is available with any Masimo SET or Rainbow Oximetry sensor. Read More
Sunshine Heart Gets FDA Nod to Conduct Study of Heart Assist System February 26, 2015 The C-Pulse Heart Assist system is for treating heart failure. Read More
bioLytical Laboratories Gets Added HIV-2 Indication for HIV Test February 25, 2015 The INSTI HIV Antibody Test can now be used to detect both HIV-1 and HIV-2. Read More
Bioness’ Chronic Pain Nerve Stimulator Gets FDA Nod February 25, 2015 The Stimrouter is designed to treat chronic, intractable pain emanating from peripheral nerves. Read More
FDA OKs 532 nm Laser Delivery System for PicoSure February 24, 2015 The new delivery system is an upgrade to the 755 nm dermal treatment. Read More
FDA Approves Covidien’s Varicose Vein Treatment February 23, 2015 VenaSeal seals affected veins with an adhesive agent. Read More
Mevion Medical’s Proton Therapy System Approved in Canada February 18, 2015 An advanced form of radiation, proton therapy targets tumor cells while sparing nearby healthy cells. Read More
Seegene Gets FDA Green Light for Herpes Virus Assay February 18, 2015 The clearance will hopefully pave the way from more tests, the Korean company said. Read More
Medtronic Launches Balloon Dilatation Catheter Following CE Mark February 17, 2015 The first patient implant was performed in Newcastle, UK. Read More
Interbody Fusion Device FDA-Cleared February 13, 2015 The FDA has granted 510(k) clearance to a spinal fusion device made by Wisconsin-based Titan Spine. Read More