SpectraScience gets FDA green light
SpectraScience (San Diego) reported that the FDA has given approval to the company to manufacture its WavStat optical biopsy system in its Sorrento Valley, California, facility.
Jim Hitchin, company CEO, said, “This approval is the result of our submission of a PMA Supplement to our existing approved PMA. It allows us to manufacture and distribute the WavStat Optical Biopsy System from our San Diego facility.“
The WavStat is able to distinguish between normal, pre-cancerous, or cancerous tissue optically as compared to the current technique of physically removing suspected tissue and waiting for a pathology report.
The system is currently approved by the FDA for use in detecting cancer in the colon. A new application for detecting pre-cancers in the throat, sometimes called Barrett's esophagus, is being tested in a clinical trial. Cancer of the esophagus is greater than 90% fatal and may develop as a result of chronic heartburn or GERD.
Longport to request SEC deadline extension
Longport (Glen Mills, Pennsylvania), a medical technology specialist in high resolution ultrasound imaging, said that it will file with the SEC to extend its deadline for filing Form 10-KSB for the year ended Dec. 31.
Longport also reported that it will participate in the poster presentation at the Wound Healing Society conference to be held May 16 in Scottsdale, Arizona. The presentation, titled “Does the Use of High Resolution High Frequency Ultrasound Provide a Clinical Advantage for the Detection and Prevention of Pressure Ulcers?“ is the result of a study done by Director of Clinical Support at Longport, Connie Phillips-Jones, RN. The presentation will highlight findings that Longport Episcan may be more accurate than overt clinical signs when predicting risk of pressure ulcer development.
In addition, Longport plans to exhibit at the Symposium for Advanced Wound Care from April 29-May 3 in San Antonio.