FDA clears IntriCon's Sirona Event and Holter Recorder

IntriCon Corporation (NASDAQ: IIN), a designer, developer, manufacturer and distributor of miniature and micro-miniature body-worn devices, today announced it has received 510(k) marketing clearance from the U.S. Food and Drug Administration (FDA), for its Sirona Event and Holter Recorder. Sirona is the company's second-generation cardiac diagnostic monitoring (CDM) device, allowing physicians to monitor patient cardiac events remotely.

The device combines event and holter recording, with IntriCon's PhysioLink^® wireless technology. PhysioLink enables audio and data streaming to ear-worn and body-worn applications over distances of up to five meters. Additionally, PhysioLink technology consumes less power than Bluetooth radios, which results in more compact devices.

"The FDA's approval of Sirona further solidifies our commitment to the CDM market space," said Mark S. Gorder, president and chief executive officer of IntriCon. "Sirona is the first device to incorporate PhysioLink—a core technology with tremendous potential. Similar to Centauri, Sirona follows current industry trends of shifting patient care from expensive health-care settings to the home. This not only reduces costs but improves patient comfort."

Sirona provides diagnostic evaluation of patients who experience transient symptoms that may suggest cardiac arrhythmia. The device's platform is essentially two products in one design since it can be used as an event recorder and a holter monitor. Additional features include its small size, rechargeable battery, and spray- and splash-proof design.

The company expects to release the product in the first quarter of 2012 and anticipates modest revenue contributions in the 2012 year.