NeedleSmart Limited have achieved FDA approval for their NeedleSmart Professional device as a Class II medical device.
The NeedleSmart Pro destroys a hypodermic needle, post procedure, by heating the needle to 1300 degrees and compressing it into a sterile, non-sharp sphere. This reduces the risk of needlestick injuries and significantly reduces disposal costs.
The NeedleSmart Pro was CE marked in 2019 and with FDA approval the Company can market the NeedleSmart Pro to a global market.
Merseyside based NeedleSmart CEO Cliff Kirby added:
I am absolutely thrilled that the NeedleSmart PRO has received FDA approval. Knowing we are the first UK Company to achieve this is a fantastic achievement and pays testament to the product and expertise of our team, and we are looking forward to new distribution partnerships in the USA.