Avacen Medical Nabs CE Mark for Avacen 100 December 28, 2016 The device infuses heat into the circulatory system to create muscular relaxation. Read More
FDA Approves Alcon’s Intraocular Lens For Cataract Patients December 28, 2016 The device addresses presbyopia and pre-existing corneal astigmatism at the time of cataract surgery. Read More
Final Order Puts Computerized Cognitive Aids in Class II December 28, 2016 These were the first devices the FDA indicated for cognitive testing after a brain injury. Read More
FDA Releases Final Guidance On Endoscope Cross-Contamination December 28, 2016 The guidance calls on makers of gastrointestinal endoscopes to consider risk-mitigation in device design. Read More
FDA Permits de novo Clearance for AirXpander’s Tissue Expander System December 23, 2016 The device is designed for patients who chose reconstructive surgery after a mastectomy. Read More
Written MDR Procedure Lands Miramar Labs a Form 483 December 23, 2016 The MDR procedure did not have instructions to file MDRs for overseas incidents for devices also marketed in the U.S. Read More
Complaint Evaluation Procedures Net Circle Prime Form 483 December 23, 2016 Records of acceptable suppliers, contractors and consultants were not being adequately established. Read More
HHS OIG Work Plan Focuses on Recalled Devices, Cybersecurity December 23, 2016 The OIG will review Medicare claims to identify how much it costs replace recalled devices. Read More
ZipLine Medical Nabs CFDA Approval for Skin Closure Device December 22, 2016 The Zip is a non-invasive wound closure device. Read More
EC Grants CE Mark to InSightec’s Exablate Prostate System December 22, 2016 The device uses focused ultrasound waves to target and destroy specific tissue in the prostate. Read More
Poor Supplier Evaluations Lead To Form 483 for CME America December 22, 2016 Potential suppliers were not evaluated and selected based on their ability to meet specified requirements. Read More
ANSM Issues Instructions For Clients of Denotified Bodies December 22, 2016 Manufacturers must submit five criteria when applying for a marketing extension. Read More