Since its inception, the EFS program has supported device innovation and increased patient access to potentially beneficial new technologies. EFS allow investigators to gain early clinical experience with investigational devices, often to address unmet clinical needs, while incorporating enhanced risk mitigation strategies to protect patients.
Author: Matthew Victoria
NESTcc Partners with Booz Allen Hamilton for Active Surveillance in Medical Devices
NEST selects Booz Allen Hamilton to partner on the design and implementation of an active surveillance system using electronic health data to better understand the safety of medical devices as used within clinical practice.
Chip Hance Appointed as Chair of MDIC Board
Chip Hance assumed the position of Chair of the Board of Directors of the Medical Device Innovation Consortium (MDIC) at the organization’s most recent Board meeting. Hance, a longtime leader in the medical device field, reflected on the opportunities ahead for MDIC as he took over Board leadership from the outgoing chair, Dr. Jijo James, Chief Medical Officer, MedTech and External Innovation at Johnson and Johnson.
Simon Mason Selected to Lead NEST
The National Evaluation System for health Technology Coordinating Center (NESTcc), an initiative of the Medical Device Innovation Consortium (MDIC), has named Simon Mason as its new President. In his new role, Mr. Mason will lead strategy and operations for NESTcc to serve its stakeholders, including patients, providers, payers, medical device manufacturers, regulators, and others.
MDIC Partners with PerkinElmer’s Horizon Discovery on Next Gen Cancer Diagnostics
MDIC has partnered with PerkinElmer’s Horizon Discovery to develop and manufacture somatic reference samples (SRSs) to simplify and support validation of next generation sequencing (NGS)-based cancer diagnostics.
MDIC Launches Somatic Reference Samples Initiative for Cancer Diagnostics
The MDIC formally launched its Somatic Reference Samples (SRS) Initiative with a pilot project to improve the validation and regulatory review process for cancer diagnostics based on next-generation sequencing (NGS).
MDIC Releases Landscape Report on Medical Device Computational Modeling and Simulation
MDIC recently released the “Landscape Report & Industry Survey on the Use of Computational modeling and Simulation (CM&S) in Medical Device Development” which discusses the potential for CM&S to reduce product development costs, speed up time to market, and better serve patients with safe and effective medical devices.
MDIC in the News: Wilson Sonsini Lifesciences Biannual Report
Discover how the FDA’s Early Feasibility Studies (EFS) Program is revolutionizing medical device approvals in the U.S., and how MDIC is enhancing this process, in this insightful interview with Cyrano Therapeutics CEO Rick Geoffrion.
MDIC In the News: MedTech Strategist
Discover how the FDA’s Early Feasibility Study (EFS) program is transforming U.S. clinical research and accelerating the development of innovative medical technologies.