Sleep apnea test gains FDA clearance

The U.S. Food and Drug Administration has granted Zephyr Sleep Technologies 510(k) clearance to begin selling the MATRx system, which is designed to help identify patients that will be successful with oral appliance therapy while establishing the protrusive position of the lower mandible for effective therapy.

"The MATRx system changes the way oral appliance therapy is prescribed, bringing the knowledge and expertise of both sleep physicians and dentists into the therapy decision much earlier," said Paul Cataford, Zephyr president and CEO, in a press release.

A MATRx study is performed in a sleep laboratory by a sleep technician in conjunction with a polysomnographic test. The MATRx test is designed to enable dentists to fit oral appliances with confidence in therapeutic outcomes while eliminating the need for an iterative titration process that previously could take weeks.

Understanding a patient's airway response to mandibular protrusion is a critical component of confidently prescribing and administering oral appliance therapy, the company noted.

In December 2010, Zephyr signed an exclusive worldwide distribution agreement with SomnoMed to market and sell this device under the name SomnoMed MATRx. SomnoMed is planning a limited U.S. market release of MATRx to select hospitals and private clinics before making it available to a broader customer base.

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