FDA Says Patient Warming Device Is Safe September 7, 2017 The agency sent the letter in the wake of a series of lawsuits claiming the device spread contaminants. Read More
FDA Unveils Spike in MDUFA Fees Effective Oct. 1 September 6, 2017 Requests for “small business” status must be submitted before Sept. 30, 2017. Read More
Phase-in of New Device Regulations Extends Beyond Brexit September 6, 2017 MDR and IVDR regulations debuted on May 25 can enter the market. Read More
Adherium Receives FDA 510(k) Clearance for Next Generation Smartinhaler September 6, 2017 The device stores the history of patient medication usage patterns. Read More
CSA Medical Wins Expanded FDA Clearance for TruFreeze Cryotherapy September 6, 2017 The tool is designed for use in dermatology, gynecology, general surgery and to ablate benign and malignant lesions. Read More
FDA Cites Metz Dental Laboratory for Validation, Other Issues September 5, 2017 The facility’s device history records were incomplete. Read More
FDA Issues Guidance on Real-World Evidence September 5, 2017 Sponsors planning to collect real-world data may be required to obtain an investigational device exemption. Read More
Apollo Endosurgery Wins CE Mark for 12-Month Orbera Weight Loss Balloon September 5, 2017 Apollo Endosurgery said expects to begin commercialization of the Orbera365 device in the fourth quarter. Read More
Philips Spectranetics Recalls Bridge Occlusion Balloon September 5, 2017 Philips recently acquired Spectranetics, consolidating it into its image-guided therapy business. Read More
Singapore Launches Device Priority Reviews, Pre-Market Consultations September 1, 2017 Devices can qualify for the priority review pathway if they address priority healthcare areas. Read More
FDA Dings Hebei Pukang Medical on Design Procedures, CAPA September 1, 2017 The company conducted no quality audits to ensure its quality system was compliant and effective. Read More
FDA Grants ExThera Medical’s Seraph 100 Blood Filter Expedited Access Pathway Designation September 1, 2017 Seraph is designed to quickly treat blood stream infections to prevent them from becoming life-threatening. Read More