Compumedics has received market clearance from the FDA for its Grael HD-PSG Sleep Diagnostic Amplifier System. The Grael HD PSG/EEG (polysomnography/electroencelaphography) is the high definition (HD) PSG/EEG amplifier.
The FDA clearance allows introduction and sale of the company’s new advanced amplifier system in the US.
The Grael features 24-bit A/D converter (including sampling and storage), 77 channels, true DC-coupling, integrated light, snore, body position and RIP (respiratory inductive plethysmography) sensors, and a single IP cable connection.
David Burton, CEO of Compumedics, said: “With Grael, Compumedics further enhances the sleep-diagnostics industry’s broadest product range, covering all regulatory types I-IV of sleep product classifications in both wireless and wired configurations. As a premier product, Grael offers the features and flexibility to meet even the most demanding research applications while providing unmatched and exceptional signal quality in any clinical lab environment.”
Phillip Moses, new VP of US sales at Compumedics, said: “We are excited to have the much anticipated Grael HD-PSG Sleep Diagnostic Amplifier System available for our customers. It further demonstrates the technological innovation that defines Compumedics and distances our company well in front of all competitors.”
“We expect Grael to significantly contribute to US revenue growth for the balance of the year and beyond. Our customers are queued up to purchase Grael, and our sales team is excited to add the Grael to Compumedics’ suite of exceptional software and lab management products. Grael allows us to truly address the most demanding clinical and research requirements.”