FDA to Unveil New Regulatory Framework for Stem Cell Therapies
August 31, 2017
By Neozene

The US Food and Drug Administration’s (FDA) Commissioner Scott Gottlieb said Monday the agency will advance a new framework to better regulate stem cell therapies this fall. “This comprehensive policy will establish clearer lines around when these regenerative medicine products have sufficient complexity to fall under the agency’s current authority, and then define an efficient process for how these products should be evaluated for safety and effectiveness,” Gottlieb said. The statement was sent out alongside a warning letter for a Florida stem cell clinic, known as US Stem Cell Clinic,

Special Report – The top companies in medtech by 2016 revenue
August 29, 2017
By Neozene

2016 was the year of the makeover. The top 10 medtech players are all in varying stages of transformation. Some companies, like Philips and Siemens, are well into their metamorphoses, while others, such as Boston Scientific and Johnson & Johnson, made moves to overhaul their medtech businesses. Others still are digesting large acquisitions from years prior and are casting about for new sources of growth. Siemens Healthcare rebranded as Healthineers in 2016, following a restructuring that broke it out as a separate business and included promises to bolster its existing

FDA Clarifies Early Feasibility Study (EFS) Program for Early-stage Medical Devices
August 24, 2017
By Neozene

The US Food and Drug Administration has published new information online explaining how medical device manufacturers may apply and qualify for limited-scope clinical investigations known as Early Feasibility Studies (EFS). The new FDA webpage explains that EFS targets manufacturers of novel or innovative devices in the early stages of development; these devices have little to no prior clinical and/or non-clinical data available, so data and experience obtained from an EFS may help sponsors and FDA reviewers assess device design concepts as well as clinical safety and performance issues on such