IntriCon Receives FDA 510(k) Marketing Clearance for Sirona Cardiac Diagnostic Monitor
November 17 2011 - 11:50AM
Business Wire
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.
About IntriCon CorporationHeadquartered in Arden Hills,
Minn., IntriCon Corporation designs, develops, manufactures and
distributes miniature and micro-miniature body-worn devices. The
company is focused on three key markets: medical, hearing health,
and professional audio communications. IntriCon has facilities in
the United States, Asia and Europe. The company’s common stock
trades under the symbol “IIN” on the NASDAQ Global Market. For more
information about IntriCon, visit www.intricon.com.
Forward-Looking StatementsStatements made in this release
and in IntriCon’s other public filings and releases that are not
historical facts or that include forward-looking terminology such
as “may”, “will”, “believe”, “anticipate”, “expect”, “should”,
“optimistic” or “continue” or the negative thereof or other
variations thereon are “forward-looking statements” within the
meaning of the Securities Exchange Act of 1934, as amended. These
forward-looking statements include, without limitation, statements
concerning prospects in the miniature body-worn device arena, new
products and their timing, strategic alliances, future growth and
expansion, expansion into new manufacturing facilities, market
fundamentals, future financial condition and performance, prospects
and the positioning of IntriCon to compete in chosen markets and
the Company’s planned investments in research and development.
These forward-looking statements may be affected by known and
unknown risks, uncertainties and other factors that are beyond
IntriCon’s control, and may cause IntriCon’s actual results,
performance or achievements to differ materially from the results,
performance and achievements expressed or implied in the
forward-looking statements. These risks, uncertainties and factors
include, without limitation, risks related to the current economic
crisis, the risk that IntriCon may not be able to achieve its
long-term strategy, weakening demand for products of the company
due to general economic conditions, risks related to the
manufacturing agreement with hi HealthInnovations, risks related to
the company’s strategic alliances and joint venture, possible
non-performance of developing the Centauri, Scenic, Overtus, APT,
Sirona, PhysioLink, Lumen, wireless glucose monitor and situational
listening device products and other technological products, the
volume and timing of orders received by the company, changes in the
mix of products sold, competitive pricing pressures, the cost and
availability of electronic components and commodities for the
company’s products, ability to create and market products in a
timely manner, competition by competitors with more resources than
the company, government regulation and review of products, foreign
currency risks arising from the company’s foreign operations,
ability to satisfy and maintain compliance with the covenants under
the company’s loan facility, the costs and risks associated with
research and development investments and other risks detailed from
time to time in the company’s filings with the Securities and
Exchange Commission, including the Annual Report on Form 10-K for
the year ended December 31, 2010. The company disclaims any intent
or obligation to publicly update or revise any forward-looking
statements, regardless of whether new information becomes
available, future developments occur or otherwise.
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