DocuSys Receives FDA 510k Clearance for its Anesthesia Information and Digital Drug Management System

Following a stringent review process, DocuSys, Inc. , a leading provider of Anesthesia Information Management Systems (AIMS) and Digital Drug Management Systems, has received 510(k) clearance from the Food and Drug Administration (FDA) to market its technology and is now a registered medical device manufacturer in accordance with FDA guidelines.

Specific medical devices, as identified by the FDA, require 510(k) clearance in order to market them in the U.S. and in a recent decision by the FDA, AIMS systems have been added to the list of products that require this clearance. Implicit in conforming to FDA regulations is compliance with Quality System Regulations (QSRs), Current Good Manufacturing Practices (CGMPs) and other applicable Code of Federal Regulations (CFR) practices.

We are pleased that DocuSys has obtained FDA clearance to market our Anesthesia Information and Digital Drug Management Systems, said DocuSys's Director of Regulatory Compliance Gordon Peters. This is a noteworthy achievement for DocuSys in ensuring that we meet the company'ss goal of providing the market with products that further the patient safety objectives of healthcare providers. The combination of our digital drug management system and our AIMS technology permits us to uniquely address safety in the complex perioperative environment.

About DocuSys:
DocuSys is the first company to provide comprehensive digitization of anesthesia by merging two of the most critical components of patient care - drug delivery and clinical information - maximizing both the quality of care and return on investment in surgery. The system incorporates customizable decision support, professional fee capture, comorbid condition documentation and an intravenous drug monitor, DocuJect®, which uses bar-coding and digital imaging to automate documentation, tracking and billing of drugs. DocuSys's modular design permits integration with existing hospital information systems, electronic drug dispensing cabinets, infusion pumps, physiologic monitors and other systems in those settings where intravenous drug delivery is key. For more information, please visit the company'ss web site at www.docusys.net.

DocuSys Receives FDA 510k Clearance for its Anesthesia Information and Digital Drug Management System

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DocuSys Receives FDA 510k Clearance for its Anesthesia Information and Digital Drug Management System

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