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March 15, 2022
Fist Assist Devices Announces Distribution Deal and Sales Launch in Australia
March 15, 2022—Fist Assist Devices, LLC, announced a 3-year affiliation with Regional Health Care Group to commercialize and launch sales of the Fist Assist Model FA-1 device in Australia and New Zealand. The company is based in Las Vegas, Nevada.
According to the company, the Fist Assist Model FA-1 is a wearable, intermittent compression device that has CE Mark clearance for use in those conditions where vein dilation is desired in patients who will require or already have undergone arteriovenous fistula placement for eventual hemodialysis; in addition, it is cleared to help with infusion-arm vein access for chemotherapy/radiology/phlebotomy access support.
In December 2021, the company announced that it received Breakthrough Device designation from the FDA for the FA-1 device for presurgical vein dilation of patients with end-stage renal disease.
On June 2021, the company announced FDA clearance for the FA-1 device with an indication for arm massage and increased vein circulation and advised that the FA-1 device is marketed for increased forearm vein enhancement and arteriovenous fistula dilation/maturation in India, Canada, Europe, Australia, and New Zealand.
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