Xhale SMART Achieves Significant Milestone with ISO 13485 Certification

GAINESVILLE, FL December 2, 2013 – Xhale, Inc.

Xhale SMART, Inc., a subsidiary of Xhale, Inc. which is marketing a breakthrough medication adherence monitoring system, today announced it has received ISO 13485 certification, an internationally recognized quality standard for medical devices.

The ISO 13485 certification covers the design, development, production, sales and service of the SMART® Adherence System, the only technology available that definitively verifies that the right person took the right dose of the right medication at the right time. The certificate demonstrates that Xhale SMART has successfully implemented a quality management system that conforms to the world-wide standard for medical device and diagnostic manufacturing.

“This achievement demonstrates Xhale’s continued commitment to the highest level of quality management and design controls to ensure delivery of safe and effective products,” said Douglas M. Crumb, Vice President of Operations for Xhale SMART, Inc. “Our customer base can be assured that the products we deliver today are of the highest standards, and that the ISO 13485 criteria will provide a quality foundation upon which we will develop our medication adherence products.”

ISO (the International Organization for Standardization) is the world’s largest developer and publisher of International Standards.

About Xhale SMART

Xhale SMART , a wholly-owned subsidiary of Xhale, is commercializing the SMART® Adherence System for the pharmaceutical industry, where it is being launched as a clinical trials tool for use in drug development. The breakthrough technology measures, monitors, reports, and improves adherence to prescribed medication regimens. The SMART® system is the only technology available that definitively verifies that the right person took the right dose of the right medication at the right time. The system is patient-centric and noninvasive. Utilizing exhaled breath, the SMART® system wirelessly reports – in real time – on medication adherence of participants in clinical trials, allowing immediate intervention when a participant misses a dose. SMART® technology is expected to have a direct impact on the success of drug approval, and help provide safer, more effective drug development.

About Xhale, Inc.

Xhale, Inc. is a medical technology innovator, developing products that transform healthcare and save lives. The company is a world leader in the use of sensors that analyze vapor and exhaled breath and is focused on novel patient-centric monitoring solutions. Its current product lines include SMART®, the world’s only definitive medication adherence monitoring system, and Assurance®, a replacement for conventional finger-based pulse oximetry which will monitor multiple patient parameters from a single-point-of-contact sensor, more comfortably and conveniently than finger-based pulse oximetry with fewer false alarms.


Download PDF: 12022013 SMART Press Release