PinPointe USA, a provider in light-based infection therapy, has received Health Canada clearance for the commercial launch of the PinPointe FootLaser in Canada.
The patented technology, available worldwide, is the first and only device to receive FDA clearance in the US, indicated for use for the temporary increase of clear nail in patients with onychomycosis (nail fungus), PinPointe claimed.
The PinPointe FootLaser is already available commercially in the US and in the European Union under a CE mark for the treatment of nail fungus, and is TGA-approved and available in Australia and New Zealand.
PinPointe USA CEO John Strisower said they are pleased about the Health Canada clearance and they were able to obtain this clearance by providing compelling data regarding the product’s safety and efficacy.
"We are pleased with the continued global acceptance of the FootLaser procedure from both a clinical and patient perspective," Strisower said.