China's FDA grants approval to Dehaier's portable sleep Dx system

Dehaier's DHR-998 sleep diagnostic device, making use of its Morpheus Ox software--Courtesy of Dehaier

China's Dehaier Medical Systems ($DHRM) won regulatory approval in its home country for software crucial to its sleep diagnostic system, nearly a year after the process began.

The medical device maker said that the China Food and Drug Administration (CFDA) has officially signed off on the company's Morpheus Ox software. Execs initially applied to the CFDA to register the diagnostic tech in July 2013. Dehaier describes its Morpheus Ox system as a portable home sleep diagnostic and monitoring tool, a watched-sized device that is cost-effective and can help diagnose apnea, sleep/wake time and breathing patterns.

CEO Ping Chen said in a statement that the company showcased Morpheus Ox at a recent sleep medicine conference in China. That, and recent marketing efforts have shown that there is "strong interest from a variety of hospitals and physical examination centers" for the diagnostic device, he said.

Dehaier noted that it now has CFDA certifications for a number of related sleep diagnostic products, including its next-generation DHR-998 sleep diagnostic device, a photoplethysmography sensor, continuous positive airway pressure ventilator and sleep diagnostic software.

Dehaier is betting on new growth from its sleep respiratory business and greater focus on mobile healthcare and telemedicine. That upswing would come after a mixed 2013 where Dehaier invested time energy and money shifting its attention more attention toward government contracts and sleep respiratory medicine, and reducing its focus on medical equipment. Dehaier has said it expects major growh in demand for its products in China, but will also pursue global sales.

Dehaier's revenue for 2013 hit $16.86 million, down more than 21%. Net income also dropped to $2 million, versus $3.22 million in 2012. When the numbers came out in April, a Dehaier representative blamed the disappointing results on a challenging market and new competition.

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