Cambridge Cognition Awarded FDA Marketing Clearance for Cantab Mobile January 25, 2017 The device includes a computerized test of visuospatial associative learning to assess episodic memory. Read More
Implanet Wins CE Mark and FDA Marketing Clearance for Jazz Frame January 25, 2017 The device is to be used in conjunction with the Jazz Band surgical technique. Read More
Neural Analytics Receives CE Mark for the Lucid System January 25, 2017 The battery-operated ultrasound device monitors blood vessels in the brain. Read More
FDA Lays Out Possible LDT Oversight Approach January 25, 2017 The FDA acknowledges growing consensus that more oversight of LDTs is needed. Read More
Viveve Gets Marketing Clearance in Malaysia January 24, 2017 The device is designed to treat the vaginal opening. Read More
Fujifilm Gains FDA Approval for its Digital Breast Tomosynthesis Option for Mammography System January 24, 2017 The software provides 3D image of breast tissue. Read More
Prescient Surgical Achieves FDA De Novo Clearance for CleanCision System January 24, 2017 The company plans to launch the CleanCision device in 2017. Read More
FDA Adds Device Scenarios to Final GMP Guidance for Combo Products January 24, 2017 The guidance is similar to the 2015 draft except for compliance for prefilled syringes, drug-coated mesh, and drug-eluting stents. Read More
FDA Clears BD’s PleurX Catheter System for Specific Non-Malignant Recurrent Pleural Effusions January 23, 2017 The device system was initially approved in 1997 for managing malignant and recurrent fluid buildup. Read More
Camber Spine Technologies Gains FDA Marketing Clearance for its Joint Fixation System January 23, 2017 The device is intended for use in adult patients as an adjunct to sacroiliac joint fusion. Read More
FDA, Health Canada Clear 7D Surgical’s Image Guidance System January 23, 2017 The device removes vision barriers during spinal surgery. Read More
FDA Awards Biolase Marketing Clearance for Epic Pro Diode Laser System January 23, 2017 This device is the newest addition to the company’s portfolio of soft-tissue diode lasers. Read More