Milestone Scientific Inc., a New Jersey company, received 510(k) Premarket Notification Acceptance from the FDA for CompuFlo™, a computer controlled local anesthesia infusion pump. The company calls the device an “‘intelligent’ computer controlled local anesthetic delivery system”, as reported by PRNewswire. Milestone Scientific Inc. is known for developing dental devices that are uniquely optimized for dental procedures that dentists are used to. For example, the CompuDent, which used a microprocessor to give a local anesthetic injection using a wand, allowed dentists to administer anesthetic while holding the device like a pen instead of the standard syringe grip.
The CompuDent seems to be have been well-received by the dental community, but will the CompuFlo? We’ll have to wait and see.
Here are some excerpts about CompuFlo:
The CompuFlo Computer Controlled Infusion Pump utilizes pressure feedback data to monitor and regulate the delivery to patients of local anesthesia, medications and other fluids, and will serve as the foundation
for the development of significant new medical and dental devices at Milestone Scientific Inc.
“The receipt of 510(k) acceptance from the FDA represents a major step for Milestone in the commercialization process for our patented CompuFlo technology,” stated Leonard Osser, Chief Executive Officer of Milestone Scientific Inc. “We are currently seeking partnership opportunities with major companies in the Regional Anesthesia market, especially in applications where safety is of paramount concern. We plan to initially target the $200 million-plus annual market for epidural injections that are administered to women during childbirth procedures in the U.S. Such injections are also used in the treatment of low back pain and pain in the lower extremities. CompuFlo’s pressure sensing technology clearly identifies the epidural space for the doctor, thereby greatly reducing the risks of paralysis and other complications that can occur when physicians attempt to locate the epidural space using tactile senses.”