News
Longport Technology Obtains Extended FDA Marketing Clearance
Longport Inc announced on December 8, 2006 that its EPISCAN high resolution ultrasound scanner had gained additional FDA marketing clearance. (see also associated press release of December 8th) The full text of this new clearance, FDA reference K062571, can be viewed and downloaded from the FDA web site through the link below.
http://www.fda.gov/cdrh/pdf6/K062571.pdf
Longport had previously obtained FDA marketing clearance for its technology through FDA clearance reference K990238.
Importantly this new marketing clearance includes a broad range of specific indications of use for our technology, as presented in the statement below.
“The EPISCAN I-200 high-resolution ultrasound system is a specialized system for imaging the skin and underlying soft tissue. It is intended for use by clinicians, or under the direction of physicians for imaging and analysis in research environments as well as clinical settings including medical / surgical dermatology assessment and diagnosis (aesthetic and therapeutic), plastic / reconstructive surgical planning, wound assessment and management, skin assessment for pressure ulcer detection and prevention and superficial musculoskeletal diagnosis.”
The clinical applications cleared for specific transducers that operate with Longport’s EPISCAN high resolution ultrasound scanner include:
- wound management and assessment
- detection and prevention of pressure ulcers
- detection of deep tissue injury
- burn depth assessment
- superficial musculoskeletal assessment
- skin lesion assessment
- aesthetics