Aïmago gets FDA clearence

Aïmago SA, a Swiss medical device company, announces FDA 510(k) Clearance of ist award-winning, next-generation perfusion camera. The tablet-based Aïmago EasyLDI greatly simplifies perfusion assessment; already CE-marked, it is in active use in several leading European plastic & reconstructive surgery, burn care and wound healing centers.
 
Aïmago’s EasyLDI provides surgeons and nurses with a highly intuitive, non-invasive, repeatable and user-independent diagnostic imaging tool to objectively identify poorly perfused tissue. This clinically relevant information empowers surgeons to reduce the risk of skin necrosis and delayed healing, thereby leading to better and earlier decision-making for a range of surgical procedures.
 
Enhanced, Real-Time LDI Brings Numerous Benefits
Aïmago’s perfusion camera uses the established Laser Doppler Imaging (LDI) technology. The skin is illuminated by laser light, part of which is reflected by moving red blood cells, which, through the Doppler effect, cause a shift in the wavelength of the laser light detected by the LDI camera. Aïmago has enhanced this technology to create a fast, intuitive and even more accurate device, providing tangible benefits compared to other existing devices:

• Compact, ergonomic design for easy, fast and intuitive use like a digital camera
• Contactless and non-invasive – no injection of fluorescent dyes like ICG
• Continuous real-time imaging with no delay or need for repeated dye injections
• Usable under ambient lighting, both inside & outside the operating room, and bedside
• For use by surgeons and nurses, without assistance of an anaesthetist or extra personnel

Michael Friedrich, co-founder and CEO of Aïmago, commented, “Our technology and design represent a new paradigm for skin perfusion assessment, with the potential to optimize surgeons’ decision-­_making and greatly facilitate the achievement of successful outcomes, thereby reducing overall cost-of-care. Having attained US clearance, we are confident that EasyLDI will soon become the new reference for perfusion assessment.”
 
About Aïmago
Aïmago is a privately held, investor-backed medical device company founded in 2008 as a spin-off from the EPFL (Swiss Federal Institute of Technology in Lausanne) and specializing in perfusion assessment in various clinical settings. Aïmago’s revolutionary EasyLDI microcirculation camera enjoys significant patent protection, is already in use at several hospitals in the EU, and is slated for launch in the US in 2012. The company has won several awards, including the CTI MedTech Award 2011 from the Swiss government and the W.A. de Vigier Award for best Swiss start-up.