The award-winning NeedleSmart PRO needle destruction device has achieved FDA approval as a Class II medical device.
Merseyside based NeedleSmart Ltd is the first UK company to achieve FDA 510(k) approval (Class II for Sharps Needle Destruction Device (NDD).
The innovative NeedleSmart PRO device heats a sharp, contaminated hypodermic needle to 1,300 degrees Celsius, then compresses the molten metal into a safe, sterile sphere of metal at the end of the syringe, removing the danger of needlestick injury and infection in just 6 seconds.
NeedleSmart’s patented technology is engineered in the UK, with offices in Knowsley, Merseyside (UK), and recently opened Pittsburgh, Pennsylvania (USA).
The NeedleSmart PRO will be used in clinical environments including hospitals and GP surgeries, and will be used in digital vaccination programmes and immunisations based in the North West.
The device offers many benefits
- Reduction of needlestick injuries (NSI) and associated costs both emotional and financial.
- Sustainability approx. 25% reduction in sharps bin requirement, leading to less waste, and contributing to the overall carbon footprint in the medical sector.
- Potential introduction of clinisafe bag/box as no longer a sharp.
- Along with associated software, the device will be used to digitalise vaccination data seamlessly, securely and safely.
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 new distribution partnerships in the USA.”
NeedleSmart is a smart med-tech business focused on better health results including safety, clinical process efficiency, cost management, and digitisation of clinical events, whilst improving sustainability. FDA approval marks a milestone in NeedleSmart’s geographic expansion to serve the North American market.