A Medical Device Daily
Elron Electronic Industries (Tel Aviv, Israel) reported that Medingo (Yokneam, Israel), a group company held 92% by Elron and its subsidiary, Rafael Development (Yokneam), has received FDA clearance to market its Solo MicroPump Insulin Delivery System.
Medingo will launch the MicroPump at the American Association of Diabetes Educators (Chicago) meeting next week in Atlanta.
"We are very excited to have received FDA clearance for Medingo's innovative, miniature, tube-free, insulin delivery system," Arie Mientkavich, chairman of Medingo and Elron said in a prepared statement. "This is a major milestone for Medingo, which will enable it to progress to the next phase in its development. Medingo is currently considering alternatives for its go-to-market strategy and the timing of the product launch."
The miniature insulin patch pump uses no tubes and can be placed under clothing on any part of the body without interfering with the patient's daily activities. It's comprised of two main units: A miniature patch pump, and a remote control unit, which allows patients to program the system and deliver insulin remotely.
As an added safety feature, the device has an occlusion sensor which alerts the patient a few minutes after occlusion.
The Solo system comes in two parts, a miniature dispensing patch unit and a separate remote control unit which allows the patient to program the system and deliver insulin remotely. The remote control includes an integrated blood glucose monitor which avoids carrying another glucometer device.
The Solo insulin dispensing patch should be reimbursable because it meets current Medicare-allowable payments and codes.
In addition to insulin delivery, Medingo devices serve as platforms for other applications, including pain control and glucose sensing. Medingo's core technology is based on research and development of Rafael, the principal research and development entity of the Israeli Ministry of Defense.
Elron owns 10 medical device firms. In addition to Medingo, the Israeli companies include Given Imaging (Yokneam), Galil Medical (Yokneam), BrainsGate (Caesaria), NuLens (Herzliya), Notal Vision (Tel Aviv), Sync-Rx (Netanya), Pocared Diagnostics (Omer) and Kyma (Tel Aviv) as well as one U.S.-based company, Impliant (Princeton, New Jersey).
Last year, Elron bought Given Imaging for $16.54 a share in cash, an aggregate of about $24.19 million.