MED Institute has obtained U.S. FDA qualification of their Medical Device Development Tool (MDDT) for virtual MRI safety evaluations, to determine if MRI imaging is safe for patients with implanted medical devices.
The MDDT program supports innovation in medical device development and regulatory science, helping to bridge the gap between research of medical devices and delivery of devices to patients. The program provides FDA with qualified tools that medical device sponsors can utilize during the evaluation and development of medical devices.
To earn qualification, FDA evaluates the submitted tool and reviews available supporting evidence to determine if the tool can provide scientifically plausible measurements. MED Institute’s MDDT utilizes computational modeling and simulation to predict RF-induced heating of passive medical devices during MRI, for both 1.5 T and 3 T, with higher quality and reliability and at a lower cost than physical testing.
“We would like to thank the FDA for the opportunity to participate in the MDDT program,” says David Gross, PhD, PE, director of MRI Safety Evaluations and Engineering Simulations at MED Institute. “We are excited to offer this MDDT to our clients and help them get their products to market faster, at a lower cost, and with better data.”
The benefits of using MED Institute’s qualified MDDT includes improvements in the regulatory review process.
For more information on uses and limitations of this MDDT, please see FDA’s summary of Evidence and Basis of Qualification.
Featured Image: MED Institute received FDA qualification of its Medical Device Development Tool to determine if MRIs are safe for patients with implanted medical devices. Photo: MED Institute
