EndoStim II Secures CE Mark Approval May 19, 2015 The second-generation lower esophageal sphincter stimulation system is indicated for the treatment of gastroesophageal reflux disease. Read More
Mauna Key Technologies’ Cellvizio Gains Expanded CE Mark May 19, 2015 The laser endomicroscopy platform can be used for laparoscopic procedures. Read More
First Patient Receives 3D Printed Cervical Titanium Structure Implant May 19, 2015 The implant successfully mimics the trabecular bone structure without the need for an added bone graft, company says. Read More
Cynosure Wins FDA 510(k) Clearance for SculpSure May 19, 2015 The device is the hyperthermic laser treatment for noninvasive lipolysis of the flanks, company claims. Read More
Ablative Solutions’ Infusion Catheter Snags CE Mark May 14, 2015 The Peregrine system is indicated for the treatment of hypertension by ablating high blood pressure-causing sympathetic nerves. Read More
St. Jude Wins Expanded EU Indication for MRI-Compatible Cardiac Devices May 13, 2015 The indication affects the company’s Ellipse ICD along with Durata and Optisure defibrillation leads. Read More
BD’s Insulin Infusion Set Wins FDA 510(k) Clearance May 13, 2015 The device significantly reduces flow interruptions in type 1 diabetics, the company claims. Read More
Medtronic’s Cryoablation Catheter Wins U.S., EU Approval May 12, 2015 The device has a 40 percent shorter tip than the previous model, allowing for better access to pulmonary veins. Read More
Roche Wins FDA Approval for Colon Cancer Diagnostic May 11, 2015 The cobas KRAS mutation test is intended for patients for whom treatment with Erbitux or Vectibix may be effective. Read More
StimGuard Receives FDA IDE Designation for Microsize Bladder Device May 11, 2015 Unlike traditional overactive bladder treatments, the wireless microsize device can be implanted completely through a needle. Read More
Nevro Gains FDA Approval for Senza System May 11, 2015 The spinal cord stimulation device is indicated to treat chronic pain without paresthesia. Read More
Surefire Medical Gets CE Mark for Infusion Systems for Embolization Procedures May 8, 2015 The system targets drug delivery directly to the liver. Read More