Neuronix Submits NeuroAD Approval Application to FDA December 5, 2016 The study enrolled 131 patients at nine medical centers in the U.S. and in Israel. Read More
Helius and U.S. Army Extend Sole Source Contract for PoNS Device Testing and Development November 21, 2016 The device is being studied in the U.S. and Canada for the treatment of chronic balance deficits. Read More
FDA’s CDRH Creates Pact to Revamp Cybersecurity in Medical Devices November 18, 2016 Collaboration aims to combat cybersecurity issues through collective strategies of stakeholders in the industry. Read More
Channel Medsystems Secures IDE Approval for the Clarity Pivotal Study November 14, 2016 The device was designed to provide an analgesic effect. Read More
Pulse Biosciences Reveals New Data of Nano-Pulse Stimulation Technology November 11, 2016 The technology has shown to jump start immunogenic apoptosis in tumor cells. Read More
Apollo Endosurgery Completes Lap-Band FDA Post-Approval Study November 3, 2016 The device is placed laparoscopically in a minimally invasive procedure. Read More
Cardiovascular Systems Announces Large Randomized Trial on Coronary Atherectomy for Calcified Coronary Lesions November 3, 2016 The clinical trial consists of up to 2,000 subjects performed in up to 60 sites. Read More
Myriad’s BRACAnalysis CDx Test Identifies Patients Who Would Benefit from Olaparib October 26, 2016 The device was included in the SOLO2 study as a diagnostic with olaparib. Read More
Somahlution Reveals Positive Study Results Showing Efficacy of DuraGraft October 4, 2016 Treatment to 2,436 patients has shown significant lower risks for adverse cardiac events. Read More
First Heart Valve That Facilitates Cardiovascular Restoration Implanted in Three Pediatric Patients October 3, 2016 The patients have been enrolled in the “Xplore-I” clinical study. Read More
Prospective Trial Shows Precision Medicine Benefits in Cancer Treatment September 29, 2016 33 percent had improved progression-free survival following a comprehensive genomic analysis. Read More
Califf Sees Big Data, Patient Participation Playing Bigger Roles in Device Assessment September 28, 2016 The agencies are interested in getting the best technology to patients earlier. Read More