FDA grants MED Institute MDDT (Medical Device Development Tool) qualification

MRI Safety Evaluations

West Lafayette, IN: MED Institute obtained FDA qualification of their MDDT (Medical Device Development Tool) 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, 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 include:

• Fosters innovation and reduces resource expenditures
• Promotes efficiency in the regulatory review process
• Minimizes uncertainty in regulatory review process

For more information on uses and limitations of this MDDT, please see FDA’s summary of Evidence and Basis of Qualification. Interested parties should contact MED Institute for any limitations on the use of this MDDT with respect to any particular device.

About MED Institute: MED Institute is dedicated to bringing new medical products to market that are safe and effective for patients. MED supports entrepreneurs, consultants, developers, and manufacturers of medical products through the entire product life cycle, providing services as needed from initial concept through product approval to post market needs.

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