KLAS Report: Baxter’s Sigma Spectrum Infusion System Tops Infusion Pump List August 11, 2016 The system has the ability to integrate with other electronic medical record systems. Read More
CSSi LifeSciences Partners With Innosphere to Expand Services August 11, 2016 Alliance is intended to benefit Innosphere’s corporate customers. Read More
Spectranetics Earns CE Mark for AngioSculptX Drug-coated Catheter August 11, 2016 The device is designed to treat coronary artery stenosis. Read More
Ascensia Launches Wireless Blood Glucose Monitoring System August 11, 2016 Device is designed to work with Medtronic’s MiniMed system. Read More
Japan’s Mitaka Kohki Hit with 483 for Quality System Failures August 11, 2016 The plant produces high-resolution microscopes used in surgery. Read More
JDRF to Partner with Pacific Diabetes for CGM Device August 10, 2016 JDRF is funding Pacific Diabetes to develop novel device for patients with diabetes. Read More
FlowAid Medical Earns CE Mark Approval for Sequential Compression Device August 10, 2016 This device causes an increase in venous blood flow from limbs. Read More
TriMed Rebuked on MDRs, CAPAs, After Device Issue Leads to Surgery August 10, 2016 The company had not submitted an MDR at the time of the FDA’s March inspection. Read More
UK Sends Out Safety Alerts for Infant Warmers, Ventilators August 10, 2016 The infant-warmer poses a fire risk in skin temperature mode. Read More
Guidance Seeks to Unify IEC, FDA Standards for X-Ray Devices August 10, 2016 The agency hopes to streamline the review process. Read More
FDA Clears Centric Medical’s Hammertoe Correction System August 9, 2016 The device is an alternative to corrective wire pins. Read More
Boston Scientific Gets FDA Approval for Emblem MRI S-ICD Device August 9, 2016 The device can treat patients at risk of sudden cardiac arrest. Read More