Biosearch® Medical Products Inc. "The Medical Innovator" is a subsidiary of Hydromer Inc. and creators of hand held electronic devices and anorectal probes which are vital components used in Anorectal Biofeedback Training and Therapy for Fecal Incontinence, Kegel Exercises and Chronic Constipation. The Biosearch Anorectal Biofeedback Monitor 5 and Monitor 10 System Kits (Perineometers and Anorectal Probes) are excellent tools for instructing patients on the correct method of performing perineal strengthening exercises (Monitor 5) and used in the training of patients troubled with Fecal Constipation also referred as non-relaxing puborectalis syndrome (Monitor 10).
Both Monitors are proven as valuable assets to Medical Professionals and Patients in helping to alleviate or minimize distressing conditions. These devices are designed for use in Clinic or for use in home by the patient (with the instruction and training of a Medical Professional recommended). Anorectal Biofeedback Monitor 5 and Monitor 10 System Kits are suitable for all ages, including smaller children.
Due to the US FDA and EU adoption of EN 60601-1, 3rd edition standards, we are required to perform expensive and time consuming tests.
We therefore are suspending any sales of the Biofeedback Monitors to clients in the USA and EU, until which time that we have completed these required tests. We hope to complete these tests by April 2014.
Please note that this does not effect the Ano-Rectal Probes or sales of the complete device to the rest of the world.