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
AV Medical Technologies Wins 510(k) Clearance for Balloon Catheter October 27, 2015 The catheter enables simultaneous balloon inflation and intravascular injection of fluids while maintaining guidewire access. Read More
Vermilion Receives CE Mark for Overa Test October 27, 2015 The test detects risk of malignancy for ovarian cancer. Read More
US Medical Innovations Plans Robotic Surgical System October 26, 2015 Company seeks patent protection. Read More
Pryor Medical Gets 510k Clearance for Catheter October 26, 2015 The device temporarily occludes large vessels using a balloon. Read More