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Federal regulators have approved an anesthesia monitoring system developed by Physiometrix Inc. The approval ends its four-year endeavor to bring the product called PSA 4000, to market.
"FDA clearance is a significant achievement for us," President and Chief Executive Officer John Williams said.
Officials at the Billerica company took it public in 1996 with the intention of launching its Patient State Analyzer, or PSA, in the coming year. It applied for approval to sell the device from the Food and Drug Administration in 1997, but clearance was delayed by clinical trial protocol changes. Technology upgrades caused further delays in 1998 and slipping stock prices and shrinking cash reserves plagued...