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Enabling surgeons with clinically-relevant, innovative fluorescence imaging solutions to enhance the lives of patients and their surgeons, while reducing health care costs, is Novadaq’s global mission. SPY fluorescence imaging technology provides surgeons with real-time visualization, leading to improved outcomes and reduced costs without exposing the patient to harmful ionizing radiation or contrast dye toxicity. More than 130 peer-reviewed publications demonstrate that the use of SPY during complex surgery, leads to fewer post-operative complications and lower hospital costs. The SPY Imaging System is United States Food and Drug Administration (“FDA”) 510(k) cleared for use in seven surgical specialties. The endoscopic version of SPY called PINPOINT®, combines the capabilities of SPY Imaging with high definition (“HD”) visible light visualization offered by conventional endoscopes. Our unique business model of partnering with market-leading companies to drive adoption of our fluorescence imaging technology, while building our own commercial infrastructure is the cornerstone of our corporate strategy for growth.
Our experienced management team has over 200 years of collective industry experience with extensive focus in medical devices. The pioneering and collaborative efforts of the management team have created an organization that strives for integrity in all actions, innovation in development activities, excellence in operations, and the highest quality products. The team is complemented by world-class medical advisors. Our products have been organically conceived, researched and developed by the Company and all manufacturing activities are conducted to ensure compliance with the U.S. Food and Drug Administration (FDA) per the requirements of 21 CFR 820, as well as ISO 13485. Femasys has achieved significant milestones to date, including numerous issued patents and filings, recruitment of a team of experts, clearance of multiple regulatory filings by the U.S. Food and Drug Administration (FDA), European Union, Canada, and Japan with other select countries in process. Making a difference in the lives of women one product at a time is a great privilege and serves to drive the Company`s mission.
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