Syneron Medical Wins FDA Clearance for CO2RE CO2 Laser Device November 5, 2015 The clearance includes more than 90 specific indications Read More
Roche Launches Three Assays for Cobas 4800 System November 5, 2015 The additions provide the cobas 4800 System with a total of 12 high medical value IVD assays. Read More
FDA Grants EAP Designation to ALung’s Hemolung RAS November 4, 2015 The device provides respiratory dialysis by removing carbon dioxide directly from the blood. Read More
Anika Therapeutics Receives Health Canada Approval for Cingal Device November 4, 2015 The device is indicated to treat pain associated with osteoarthritis of the knee. Read More
FDA Grants De Novo Clearance for INVOcell November 4, 2015 INVOcell is an intravaginal culture system used for the incubation of eggs and sperm during fertilization and early embryonic development. Read More
Mainstay Medical Submits CE Mark Application for ReActiv8 November 2, 2015 ReActiv8 is an implantable neurostimulation system to treat disabling chronic low back pain. Read More
Integrity Applications Advances in FDA Approval Process for GlucoTrack October 30, 2015 The parties met to discuss clinical trial protocol. Read More
FDA Grants Expedited Access Pathway to MyoRegulator PM-2200 System October 30, 2015 The device is being developed for the treatment of muscle spasticity. Read More
Nephros Submits Filter to FDA for 510(k) Approval October 29, 2015 The filter provides hospitals and medical facilities with temporary protection from bacteria. Read More
Thermo Fisher Scientific Wins 510(k) Approval for Hydrocodone Immunoassay October 28, 2015 The test specifically detects hydrocodone at the 300 ng/mL cut-off. Read More
Cynosure Wins Health Canada Approval for MonaLisa Touch Laser Procedure October 28, 2015 The laser is designed to treat symptoms related to Genitourinary Syndrome of Menopause. Read More
Mauna Kea Technologies Awarded 510(k) Clearance for Use of Cellvizio in Surgery October 27, 2015 Cellvizio provides a real time microscopic image of tissue. Read More