Cardiopulmonary Corp. Receives Additional FDA 510(k) Class II Clearance Broadening Bernoulli® Enterprise’s Indications for Use with Medical Devices
Centralized Patient Surveillance and Remote Alarm Notification Software has been Expanded to Include IV Infusion Systems, including PCA
MILFORD, Connecticut, October 12, 2009 — Cardiopulmonary Corp., (“CPC”), the developer of Bernoulli® Enterprise, has received an additional FDA 510(k) Class II clearance broadening Bernoulli’s indications for use with supported devices to include intravenous (IV) infusion therapy and enteral feeding systems. The Bernoulli software receives drug delivery or related clinical data from IV infusion therapy devices, including PCA. Support for IV infusion therapy systems is the latest CPC initiative in centralized patient safety surveillance.
Bernoulli provides concurrent monitoring of heterogeneous medical devices throughout general floor and acute care monitoring venues. Bernoulli is a vendor neutral, device agnostic application providing connectivity to medical devices such as oximeters, capnometers, patient monitors, and ventilators. In addition, it supports alarms, messaging, and connectivity to electronic medical records. Now with the extension of IV infusion therapy systems, clinicians can centrally monitor patients on these types of devices and receive drug delivery status and related alarm messages remotely in real-time via handheld devices. These capabilities will result in more timely interventions which will reduce patient risk.
“These extensions of our Bernoulli system offerings are examples of our continuous strategy to integrate clinical systems or devices to drive patient safety,” said Kevin Flynn, EVP of Sales & Marketing. Mr. Flynn went on to say, “It reinforces our leadership position in the remote patient surveillance market by enhancing our platform of software solutions supporting disparate devices”.
The addition of IV infusion therapy devices to the Bernoulli® platform positions CPC for continued growth in the Healthcare IT market segment by broadening its offerings of industry-leading connectivity solutions as hospitals invest in innovative technologies which can significantly improve patient outcomes.
About Cardiopulmonary Corp. Cardiopulmonary Corp. is a leader in enterprise patient safety surveillance. The company is dedicated to improving patient care and reducing preventable patient death. The company’s flagship solution, Bernoulli Enterprise, provides an open platform for real-time surveillance and secondary alarming for a wide-range of medical device types.
Bernoulli is a unique safety net for acute care patients where response time and pre-emptive patient care is required.
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According to the FDA, an MDDS is precluded from use in active patient monitoring.Vendors whose solutions are intended for use in active patient monitoring are required to maintain FDA Class II status.