MELODY: Waves that Break Barriers to Improve Lives

The 21^st century has brought us many new technologies that have improved lives, and now AdEchoTech has added one more innovation to the list:

MELODY. 75 YEARS after the first sonography was used for medical diagnosis by neurologist Karl Dussick, AdEchoTech has designed and developed a telerobotic ultrasound system called MELODY, which makes expert ultrasound examination possible anywhere in the world that has an internet connection. MELODY uses robotic technology and the internet to connect patients with trained sonographers to image fetuses, small organs, peripheral vessels and conduct abdominal, pelvic, and urologic examinations remotely.

MELODY’s robotic frame, which holds the transducer of a third-party ultrasound device, is held by a trained assistant on the patient, while the transducer is guided remotely by the expert sonographer through a third-party video conferencing system. The distant expert moves a dummy ultrasound transducer which transmits a signal through the internet connection. Each movement and image adjustment made by the doctor is mimicked by MELODY and the ultrasound image can be seen and manipulated at both locations in real-time. MELODY can help countless patients around the world. For example, a patient who lives in small or rural town, where a qualified ultrasound technician may be miles away, can easily connect with a doctor or ultrasound technician for routine check-ups or where time is of the essence.

This new technology is already in use in:

• France
• Canada
• South America
• And NOW has been cleared (with the help of FDAImports.com) for use in the United States

Clearance of a medical device can be an involved process, especially if it’s a unique product that the FDA has not reviewed in the past, like MELODY. To clear a medical device for marketing in the US, a company needs to submit a thorough pre-market notification, known as a 510(k) submission, that details its intended use, description, device class, labeling, safety and effectiveness, and how it compares to a predicate device already legally marketed for the same intended use. To obtain “clearance,” the 501(k) application must demonstrate that the medical device is substantially equivalent to the predicate device. The FDA frequently requests more information before filing or after reviewing the submission, which can delay clearance of the medical device.

MELODY is not the first remote ultrasound solution that can capture imaging information without an expert present. Unlike assisted remote sonography the expert can only see and interpret the medical images from a distance, which taken by the medical assistant conventionally, MELODY allows the expert to carry out his own medical images from a distance… FDAImports.com was involved early in the process of MELODY’S clearance. To help assure success, FDAImports.com helped AdEchoTech file a Pre-Submission request, which served to ask FDA questions and request guidance.  Through this mechanism, FDA suggested the predicate device for MELODY and provided information which proved invaluable in designing the 510(k) submission. FDAImports.com helped organize and present the required information to FDA in a format and language required by FDA. FDAImports.com explained FDA’s questions to AdEchoTech in a non-convoluted language and helped them answer FDA’s questions and concerns. When FDA pointed out the potential problems a slow or intermittent internet signal could cause, FDAImports.com helped AdEchoTech prove that it would not affect MELODY’s safety or effectiveness.

FDAImports.com understands FDA’s language, having decades of experience in the Agency. Our experts put themselves in FDA’s seat and assess the information with that viewpoint.

1. We ask questions FDA might ask and help shape and mold the information you submit to reflect FDA’s mindset.
2. We point FDA to the information they are looking for so the reviewer easily finds the facts they need to review the medical device. This is especially important when FDA reviews a medical device they have not seen before.
3. We help present and describe the innovation in a way that FDA will understand how it works, and that it is safe and effective.
4. We guide the decisions you have to make before organizing a 501(k) application, help assess studies designed to show safety and efficacy, and review labeling, including instructions for use.
5. Finally, FDAImports.com assists firms to conform to the many additional FDA regulatory requirements.

At FDAImports.com we empower people and improve lives. Now as a cleared medical device, MELODY is improving lives everyday by contributing to the democratization of medicine. It provides virtual access to health care professionals and empowers patients to improve their health care outcomes.