FDA Grants Abbott Marketing Clearance for Zika Virus Test February 2, 2017 The Abbott real-time Zika test is designed for use on the m2000 real-time system. Read More
FDA Grants Approval to Lantheus Medical Imaging’s Definity Label Update February 2, 2017 The device is indicated for use in patients with suboptimal echocardiograms. Read More
FDA Expands Clearance for Brain Surgery Technology February 1, 2017 The agency has expanded the indication for two brain surgery devices. Read More
EU Expands CE Mark Indication for Agilent Technologies’ Dako Companion Diagnostics February 1, 2017 The device allows for detection in all patients. Read More
Abbott Gains FDA Approval for its Assurity MRI Pacemaker February 1, 2017 The devices are not affected by MRI scans. Read More
Advanced Breath Diagnostics Hit With 11-Count Form 483 February 1, 2017 Three of seven completed CAPA records contained no documentation of verification or validation activities. Read More
UK’s NICE Recommends Use of SecureAcath January 31, 2017 The device is used to affix PICCs to the skin. Read More
Illumina Receives CE Mark to VeriSeq Analysis Software January 31, 2017 The software includes a method for processing samples and is designed for larger batches. Read More
Medtronic Gains CE Mark for Lower Profile HawkOne 6F Directional Atherectomy System January 31, 2017 The HawkOne system is designed to remove plaque from the vessel wall and restore blood flow. Read More
Sontec Instruments Cited for Design History, Other Violations January 31, 2017 Inspectors found the design history file did not show the design was developed following regulatory requirements. Read More
Device Companies Urge Trump to Support Value-Based Care January 30, 2017 Stakeholders are calling for an expansion of waivers from fee-for-service regulatory requirements. Read More
Cell Marque Cited for Device Acceptance Procedures January 30, 2017 The company had not defined acceptance criteria for its in vitro diagnostic device. Read More