KING OF PRUSSIA, Pa.,
Oct. 6, 2016 /PRNewswire/
-- Trice Medical announced today that it received 510(k)
clearance from the U.S. Food and Drug Administration ("FDA") for
mi-eye 2, a disposable needle with a fully integrated camera that
enables physicians to use advanced diagnostic imaging to visualize
joint injuries in their clinic. The mi-eye 2 is designed for use in
diagnostic and operative arthroscopic and endoscopic procedures to
provide illumination and visualization of an interior cavity of the
body through either a natural or surgical opening. The mi-eye 2
also provides physicians the ability to inject or aspirate under
direct visualization.
The mi-eye 2 is Trice Medical's second, next-generation
FDA-cleared patented technology, which includes improvements that
significantly enhance the mi-eye's resolution, field of view, depth
of field and overall visualization.
"Based on feedback we received from our surgeon advisory board,
we promptly implemented and pursued FDA clearance for the
next-generation mi-eye 2," said Jeffrey
O'Donnell, Sr., President and CEO at Trice Medical. "Our
team made dramatic enhancements to the technology of the mi-eye,
which reflects our continued commitment to patients by introducing
our technology into a medical practice, and working to ensure that
the mi-eye technology becomes the standard of care for providing an
immediate real-time diagnosis. Our long-term goal is to eliminate
the need for MRI exams and enable a quicker road to recovery."
The Need for New Diagnostic Technology
Currently there are approximately 28,000 orthopedic surgeons
seeing 20 million office visits annually for knee-related problems.
In addition, there are 12 million visits annually related to
shoulder pain. MRI's are often inconclusive, or result in false
readings, which has the potential to lengthen the timeline from
diagnosis to recovery. In addition, not every patient is a
candidate for MRI. The mi-eye 2 provides a diagnostic modality for
every patient, and can provide time-savings to the patient by
eliminating the multiple visits associated with an MRI. The mi-eye
2 is unlike any other in-office arthroscopy device on the market
today, and provides unparalleled optics with the ease of use of a
needle.
About Trice Medical
Trice Medical was founded to fundamentally improve orthopedic
diagnostics for the patient, physician, and payor by providing
instant, eyes-on, answers. Trice has pioneered and evolved,
fully integrated camera-enabled technology that provides a clinical
solution optimized for the physician's
office. Trice's mission is to provide more immediate and
definitive patient care, eliminating the false reads associated
with current indirect modalities and significantly reduce the
overall cost to the healthcare system. Trice Medical's
investors include Safeguard Scientifics (NYSE: SFE), BioStar
Ventures and HealthQuest Capital. For more information,
visit www.tricemedical.com; follow us on Twitter,
LinkedIn and Facebook; or call 844.643.9300.
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SOURCE Trice Medical