FDA Seeks Comment on Proposed Information Collection for UDI Requirements September 15, 2016 The FDA is requesting comments on the accuracy of its estimate of burden Read More
FDA Backtracks on UDI Compliance Deadlines for Some Class II Devices September 15, 2016 The agency announced that it would push back UDI compliance dates to Sept. 24, 2018. Read More
Ginolis Introduces Lateral Flow Device Assembly Solution September 14, 2016 The device provides manufacturers flexible production capacity. Read More
QImaging Launches the Retiga Electro CCD Camera for Electrophysiology September 14, 2016 The fanless cooling used in the device eliminates vibration and enables accurate placement of electrodes. Read More
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