EMA Seeks Stakeholder Comments on Companion Diagnostics August 11, 2017 One problem for the agency is that EU legislation covering marketing of drugs and IVDs is not linked. Read More
Optovue’s Ocular Mapping Software Wins FDA Nod August 11, 2017 The software is intended for quantitative measurements of the cornea’s epithelial and stromal layers. Read More
FDA Clears In2Bones Foot Repair Systems August 11, 2017 The agency cleared the 5MS Fracture repair and CoLag locking compression screw system. Read More
TGA Proposes to Reclassify Synthetic Meshes as ‘High Risk’ August 11, 2017 Transvaginal mesh devices and mesh used for hernia repair may soon be classed as "high risk" by the Australian government. Read More
Tate Technology Lands Form 483 for Complaint, Record-Keeping Procedures August 11, 2017 Tate Technology failed to properly evaluate complaints or keep records of nonconformances, according to the FDA. Read More
GFS Chemicals Cited for Complaints, Records August 10, 2017 The company sells laboratory equipment and chemicals to a variety of customers, including pharmaceutical firms. Read More
Most Users Accept Sharing Data From Networked Medical Devices August 10, 2017 The survey results reflect distinctions consumers make among who gets information and how it is used. Read More
Allergan IUD Gets FDA Nod for Extended Use August 10, 2017 The device was approved in February 2015 and the agency granted it additional approval for a single-handed inserter last January. Read More
FDA Clears AUM’s Heart Sound Monitoring Devices August 10, 2017 The CADence device is designed to help physicians track heart murmurs. Read More
FDA’s Patient Engagement Advisory Committee Announces Inaugural Meeting August 9, 2017 The nine-member committee will meet “once or twice a year,” the agency says, and the meetings will be open to the public. Read More
FDA Gives Nod to Mauna Kea Miniprobes August 9, 2017 The company recently released trial data supporting the use of its Cellvizio device in diagnosing pancreatic cysts. Read More
TGA Proposes to Reclassify Synthetic Meshes as ‘High Risk’ August 9, 2017 Surgical mesh is used to provide temporary or permanent support for weakened structures and/or muscles in surgery. Read More