FDA approves startup's technology for prostheses fitting

Biomedical startup Adapttech has seen its technology for improving the fitting of lower limb prostheses receive approval from the Food and Drug Administration as a Class I medical device.

The company’s Insight system, which has already undergone successful user testing in Europe, is now being used in an outcome study at two prosthetic clinics in the United States ahead of its commercial launch later this year.

Stuart Mead, the newly-appointed chairman of Adapttech, said: “Securing the FDA’s decision on Insight is a key business milestone for Adapttech and we are now fully focused on launching in the U.S. market this year. Our technology is proven, we have the team in place to support it, and we are ready to transform the way that prostheses are fitted.”

Insight combines laser scanning, wearable technology and a mobile app to make it faster and easier to correctly fit lower-limb prosthesis and monitor a patient’s entire rehabilitation process.

• The laser scanner creates a 3D model of the socket in less than 90 seconds; 
• The wearable device uses sensors to gather real-time data between the residual limb and the socket to pinpoint exactly where issues are occurring;
• The mobile app shows the clinician where issues are occurring in the 3D model, and also allows results to be registered and assessed at any time and in any place.

Frederico Carpinteiro, founder, Adapttech, said: “When fitting a lower limb prosthesis, it can take weeks to achieve a final, properly-fit solution, with several appointments often required, which is inconvenient for the patient and clinician alike. Using Insight, clinicians spend less time attending to patients with limb-socket problems; technicians spend less time fitting, assessing and refitting sockets; and patients spend less time visiting and re-visiting the clinic. Insight has the potential to help prosthetic facilities improve their patients’ lower limb functional mobility scores, which can help them access better prostheses from their healthcare provider.”

The completed European study, conducted at the Centro de Medicina de Reabilitação de Alcoitão in Portugal, demonstrated that Insight reduced the time taken for fitting and patient evaluation when fitting residual limb sockets. The U.S. study is using clinically recognized tests and validated scales for health, function, satisfaction and pain level, and is running at two independent clinics: De La Torre Orthotics and Prosthetics in Pittsburgh, PA, and Prosthetics & Orthotic Associates in Middletown, NY. 

Edward De La Torre, president, De La Torre Orthotics and Prosthetics said: “We’re excited to be one of the first clinics in the United States to access this technology. By using Insight in our fitting and evaluation process, we expect to see improved patient health, reduced pain levels, and increased patient activity by greatly improving the initial patient/prosthetist experience. Insight allows our prosthetists to more accurately fit the socket to the patient sooner, and who doesn’t appreciate that?”

Thomas Passero, founder, Prosthetic & Orthotic Associates, added: “By integrating Insight into our patient management system, we aim to reduce the amount of time prosthesis fitting and evaluation takes for the benefit of both our patients and medical operators. We hope that Insight will help us improve patients’ Ampro K-level scores, opening up a new world of opportunity for access to more advanced prostheses.”