Vygon to Buy Perouse Medical July 7, 2015 Vygon will gain access to the French devicemaker’s 162 patents. Read More
Theranos Wins FDA Nod for Herpes Finger Stick Test July 6, 2015 This is the company’s first clearance. Read More
Alcon Gains CE Mark for Intraocular Lens Delivery System July 2, 2015 The system combines a manually loaded device with a disposable, pre-loaded injector, company claims. Read More
BioLight’s Bladder Cancer Test Secures CE Mark July 1, 2015 In a clinical trial, the product displayed sensitivity rates of 84.4 percent and specificity rates of 82.7 percent, company claims. Read More
Velano Vascular Gains CE Mark for Blood Draw Technology June 30, 2015 The device uses a peripheral intravenous catheter to gather blood specimens. Read More
Centinel Spine’s Stalif Line Wins Expanded Indication June 30, 2015 The products can be used for multilevel, cervical spine fusion procedures. Read More
Acelity’s Revolve Fat Grafting System Launches in EU June 29, 2015 The single-use device processes fat tissue in reconstructive surgeries Read More
NCCN Recommends Opko’s 4Kscore for Prostate Cancer Early Detection June 29, 2015 The blood test is indicated for use prior to a first biopsy or after a negative biopsy. Read More
Exactech Wins FDA Nod for Optetrak Logic Prosthesis June 26, 2015 The implant is indicated for patients undergoing total knee replacement surgery. Read More
SomnoMed’s Sleep Apnea Device Gains FDA 510(k) Clearance June 25, 2015 The SomnoDent provides continuous open airway therapy while sleeping. Read More
Spectranetics Gains FDA Nod for New AngioSculpt Products June 25, 2015 The balloon catheters target lesions in the hemodialysis access site resistant to standard balloon angioplasty. Read More
SentreHeart Secures FDA Approval for Amaze Trial June 25, 2015 The study is evaluating the Lariat suture delivery system’s ability to provide closure of the left atrial appendage. Read More