DePuy Synthes Gains FDA Clearance for Two Cement-Augmented Pedicle Screw Systems January 26, 2017 The systems may be used in spinal fusion surgery. Read More
FDA Grants Clearance to GEO Bone Screw System January 26, 2017 The device is for single-use only. Read More
Pemco Lands Form 483 For Correction and Removal Actions January 26, 2017 Inspectors found that non-conforming products were not adequately controlled. Read More
Treasury Department Eases Sanctions on Medical Device Exports to Iran January 26, 2017 Medical devices classified as EAR99 are now generally authorized for sale and export to Iran. Read More
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