FDA Grants IntriCon Corp (IIN) 510(k) Marketing Clearance or Sirona Cardiac Diagnostic Monitor
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IntriCon Corporation (NASDAQ: IIN) 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 company expects to release the product in the first quarter of 2012 and anticipates modest revenue contributions in the 2012 year.
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 company expects to release the product in the first quarter of 2012 and anticipates modest revenue contributions in the 2012 year.
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