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Venus gets 510(k) clearance for fractional skin resurfacing technology

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The US Food and Drug Administration (FDA) has granted 510(k) clearance to market Venus Concept’s AI.ME next generation robotic technology intended for fractional skin resurfacing.

Leveraging a visualisation system, machine vision and artificial intelligence (AI) algorithms, this non-surgical platform acts on the dermis in a priorly planned, selective and predictable way. 

Up to 10% of skin in the treatment region is removed by utilising the technology’s array of micro-coring hollow punches to accurately core and remove micro-skin fractions at a particular depth.

This leads to the deposition of collagen and causes the treated area’s fractional skin resurfacing.

AI.ME is said to be the first-of-its-kind robotic system to provide physicians with less-invasive treatments for procedures with increased demand and require fractional skin resurfacing. 

With the latest approval, the company plans to introduce the first AI.ME systems in the US next year.

Venus Concept CEO Rajiv De Silva said: “We see AI.ME as a versatile platform and we will continue to develop the platform to provide innovative solutions in various areas of medical aesthetics, starting with fractional skin resurfacing. 

“The AI.ME technology will be critical to maximising the synergy between our well-established medical aesthetic business and our pioneering robotics business driven by a robust R&D pipeline developed by our team in San Jose.” 

Apart from the AI.ME system, the product portfolio of the company comprises aesthetic device platforms, such as Venus Versa, Venus Legacy, Venus Velocity, Venus Fiore, Venus Viva, Venus Glow and Venus Bliss among others. 

It also has hair restoration systems including NeoGraft and the ARTAS iX Robotic Hair Restoration system. 

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