Spectranetics Gains FDA Nod for New AngioSculpt Products June 25, 2015 The balloon catheters target lesions in the hemodialysis access site resistant to standard balloon angioplasty. Read More
Medtronic Launches SureScan Pacer in U.S. June 25, 2015 The single-chamber device enables scans without positioning restrictions. Read More
SentreHeart Secures FDA Approval for Amaze Trial June 25, 2015 The study is evaluating the Lariat suture delivery system’s ability to provide closure of the left atrial appendage. Read More
Cardiac Dimensions Enrolls First Patients in Carillon Efficacy Trial June 25, 2015 The device is indicated for the treatment of functional mitral regurgitation. Read More
S-Bio’s BlotGlyco Kit Launches in U.S. and EU June 24, 2015 The product is meant to help bioprocess development and biomarker research. Read More
Medtronic Recalls Neonatal and Pediatric Tracheostomy Tubes June 24, 2015 Certain lots manufactured after Nov. 29, 2012, were formed with a wider angle bend than standard models. Read More
Torax’s Linx System Gains FDA Nod June 24, 2015 The MRI-conditional, reflux management system is indicated for patients with gastro-esophageal reflux disease. Read More
Google Develops Cardiac Sensor Wristband June 24, 2015 The product measures basic biological signals such as pulse, activity level and skin temperature. Read More
Advanced Cooling Therapy Snags FDA De Novo Clearance for Esophageal Cooling Device June 24, 2015 The product is the only temperature modulation device to use the esophageal space to cool or warm patients, company claims. Read More
Second Sight Touts Positive Retinal Implant Study Data June 23, 2015 Up to 89 percent of patients implanted with Argus II performed tasks better at three years than those in the control arm, company says. Read More
Siemens’ HIV Combo Assay Wins FDA Nod June 23, 2015 The assay detects an HIV viral protein and antibodies generated in response to the infection. Read More
Biotronik Enrolls First U.S. Patient in Vascular Intervention Study June 23, 2015 The Osiro stent trial’s primary endpoint is target lesion failure at 12 months following surgery. Read More