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A medical device reimbursement strategy expert recently shared some of his top tips for successful clinical trial design.
As technology evolves and medical devices change as a result, creating even more challenges for regulators, clinical trial designs must adapt to the emerging trends.
Drs. T.J. Mosher and G.E. Gold, two of MMI’s thought leaders, recently were published in a review of the best practices for knee OA imaging in clinical trials.
A new guidance document, “Patient Preference Information –Submission, Review in PMAs, HDE Applications, and De Novo Requests, and Inclusion in Device Labeling,” aims to allow patient perspectives to play a greater role in the regulatory process.
With the proper consideration and a clear understanding of what you value in a CRO, it is possible to develop an outsourcing strategy that can get your product to market more efficiently and with greater evidence to support it.
A recent survey of industry professionals found that the medical device market is growing increasingly competitive, emphasizing the need for high-quality clinical trial data.
To identify the ideal CRO to meet the imaging needs of your trial, it is important to involve them at the very beginning of the process.
Sponsors of extra-U.S. trials need to carefully monitor the FDA’s requirements for the submission of foreign data.
A major health insurers group has penned a letter to a U.S. Senator in criticism of the 510(k) approval pathway.