Fluxion Biosciences Presents IsoFlux Cytation Imager for Automated CTC Analysis September 14, 2016 The IsoFlux System uses blood to perform a real-time "liquid biopsy". Read More
FDA Raises Cook Recall to Class I September 14, 2016 Cook Medical announced the recall in August. Read More
510(k) Guidance Specifics Recognition Process for Third-Party Reviewers September 14, 2016 The guidance provides a broad look at the agency’s outlook on third-party reviews of devices. Read More
FDA Grants Approval to Obalon Balloon System September 13, 2016 There were 387 patients in the U.S. across 15 clinical trial sites in the study. Read More
FDA Gives ‘Go Ahead’ to Omega3-Rich Fish Skin for Surgical Applications September 13, 2016 Kerecis’s Omega3-rich fish skin has received clearance from the FDA for marketing as a surgical reinforcement in the U.S. Read More
EBR Systems Obtains FDA Approval to Begin Study of Wireless Cardiac Pacing System for Heart Failure September 13, 2016 The company’s device is designed as an endocardial pacing system. Read More
Ovarian Cancer Screens Unreliable, FDA Says September 13, 2016 Women who show no symptoms might delay effective preventive treatments. Read More
New York Attorney General Probes Mylan EpiPen School Contracts September 13, 2016 Eric Schneiderman contends the company may have included anticompetitive terms in sales contracts. Read More
Ossix Volumax Receives FDA 510(k) Clearance September 12, 2016 This product is designed to restore lost volume in periodontal regeneration. Read More
NovaBay Pharmaceuticals’ Neutrox Receives CE Mark and ISO Certification September 12, 2016 Neutrox is NovaBay’s hypochlorous acid used in their Avenova eye care product. Read More
Ethicon Widens Portfolio with Addition of Enseal X1 Large Jaw Tissue Sealer September 12, 2016 The device designed for surgeons to use during open procedures such as colectomies and hysterectomies. Read More
Failure to Submit Medical Device Reports Leads to 483 for Metrix September 12, 2016 Metrix contacted a hospital customer and instructed them to scrap the bags, but it did not file a report. Read More