Leading medical device provider, Blood Cell Storage, Inc. (BCSI), has announced that their newest product, SAFE Sens IVM (in vessel monitoring), has begun shipping to customers and is generally available. SAFE Sens IVM, is a pH monitoring system used by embryologists and clinical staff, that reports, trends and archives pH measurements without disturbing culture conditions within a closed incubator. This announcement was made during the American Society for Reproductive Medicine (ASRM) annual event in Boston.
The SAFE Sens (Sterile, Automated Fluoroscopic Evaluation) is an optical fluorescent measurement device. It is used in combination with a disposable sensor, to accurately and reliably measure the pH of small volumes of fluids such as the media used in IVF. The sensor contains a proprietary fluorescent dye that is pH sensitive. Each lot of sterile sensors last six (6) days and have a certification pHID supplied by the manufacturer. This pHID code is used to tell the SAFE Sens device how to specifically interpret the fluorescent measurement for each lot of sensors into a pH value.
Since it is important to make sure that over time the SAFE Sens IVM continues to perform the optical fluorescent measurements properly, the SAFE Sens system uses a Quality Control Standard, qc1. The qc1 device has a known fluorescence value allowing the SAFE Sens device to compare and adjust itself to the known value. When the value is outside of the acceptable bounds the SAFE Sens IVM will alert the user and automatically make an adjustment to bring the system back into control.
"Our early customers are validating that pH monitoring and control is key," said Russ Aldrich, CEO, BCSI. "We're hearing over and over that pH control is a requirement for achieving better ART outcomes."
The SAFE technology is covered by multiple issued and pending US and International equivalent patents.
Blood Cell Storage, Inc. (BCSI), a privately held international medical device company based in Seattle, Washington, with European operations located in The Netherlands.