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FDA Clears the ProteXsure Protective Needle Capsule System

July 6, 2016 By Prism Medical & Design

The FDA has granted Prism Medical & Design clearance for its ProteXsure safety capsule system designed to reduce dangerous and sometimes fatal needle stick injuries for at-risk health care workers, caregivers, consumers and downstream waste management workers.

The system is patented, disposable and contains 100 protective needle capsules that are used to cover a needle tip after injection to injuries.

Globally, there are 3.5 million such cases reported annually, with 70 percent occurring while disposing of the needle. In the U.S. alone, there’s roughly 1 million incidents reported annually with an associated treatment cost of $3.5 billion.

Needle stick injuries are an epidemic and lead to life threatening diseases such as: Hepatitis B, C, and HIV.

The ProteXsure system, which earned CE Marking in February, is automated, requires only one hand to operate and automatically advances to the next capsule after a needle is inserted into the device and covered.

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