The Canadian Dermadry Iontophoresis Machine for treating excessive sweating has been cleared by the Food and Drug Administration, allowing U.S citizens to purchase and use the machine for hyperhidrosis condition.
As a U.S general trade rule, importers of all products are required to have marketing authorisation from FDA which can be a certificate of product registration or certificate of product notification.
The machine which was launched and licenced in 2018 by the Canadian Health Ministry adds FDA certificate to other international certificates; L’Ordre des Podiatres Podiatres du Quebec and Canadian Podiatric Medical Association. Additionally, it holds an Australian Therapeutic Goods Administration.
The iontophoresis machine was availed to U.S citizens on February 26 and it follows stringent public safety requirements.
Dermadry said in a statement that it is happy to enter the U.S market which demands their services and having an FDA certificate will make the company reach its untapped market. According to Hyperhidrosis Clinic USA the Dermadry iontophoresis machine is a very versatile device that comes at a very affordable price.
Iontophoresis which treats excessive sweating of underarms, feet and hands; is a natural, drug-free, non-invasive and needle-free treatment. The machine transfers a slight electric current through water using a shallow pan for hands and feet or different pads for other parts of the body and through the surface of the tissue. So far, there are no immediate harmful side effects that have been detected.
Excessive sweating is a medical condition that is also known as hyperhidrosis and it is estimated to affect over 5% of the global population.
America is estimated to have 2%-3% of the population suffering from severe axillary hyperhidrosis (underarm sweating) and palmoplantar hyperhidrosis (foot palms and soles). This condition is hereditary causing excessive sweating on various body parts such as palms, underarm, feet and ears; and it can start at an early average age of 13. Most people suffering from this condition are ashamed to consult experts and they suffer silently. The iontophoresis machine will provide the residents with a home-based treatment that will help them to reduce sweating.
Patients need a prescription to purchase an iontophoresis machine and Dermadry manufacturer has partnered with U.S telemedicine provider, SkyMD, to enable patients to receive a diagnosis and prescription online.
The clinically proven machines are said to have a success rate of 93% to 100% in treating the severe sweating condition.
Dermadry is targeting to reach the global market and it will be showcasing its device to medical conferences and events across the U.S to raise hyperhidrosis and iontophoresis treatment awareness. The iontophoresis machine has so far been showcased in the biggest healthcare conference in the Gulf Cooperation Council (GCC). The company says that it is looking forward to acquiring more global certificates.
The Dermadry have three machines for treating iontophoresis. There is Dermadry Total which is a one-stop solution to excessive sweating on feet, under arms and hands. Dermadry Hands and Feet machine can be used to treat hands and feet while Dermadry Underarms is specifically made to treat underarms severe sweat. The treatment session of about 20 minutes can provide your body with dryness of about 6 weeks.