OCTOBER 10, 2008 -- Two developers of laser-based biomedical equipment have announced their first product sales. CustomVis (Perth, Australia), which specializes in solid-state laser systems for laser eye surgery, says it has made the first sale of its flagship product, the Pulzar Z1, in Peru. According to the UK's The Guardian newspaper, the company's stock jumped 50% to 0.75p after it announced the first milestone event.
Similarly, Imaging Diagnostic Systems Inc. (Fort Lauderdale, FL), developer of laser optical breast cancer imaging systems, says it has received the first order for its CT Laser Mammography System (CTLM) system from distributor, The Oyamo Group. The system will go to the Hadassah University Medical Center, a tertiary care referral facility known for pioneering new medical techniques, in Jerusalem, Israel.
Dr. Miri Sklair, Head of Hadassah's Department of Mammography, will use the CTLM system in addition to mammography and ultrasound in detecting breast cancer. A premier teaching hospital and research center, the Hadassah University Center is equipped with sophisticated diagnostic, treatment and research equipment, enabling its renowned faculty to furnish modern medical care in an atmosphere that embraces excellence.
Imaging Diagnostic Systems is currently collecting data from clinical sites for the future filing of an FDA Premarket Approval (PMA) for the Computed Tomography Laser Mammography system to be used as an adjunct to standard methods of mammography. The FDA has determined that the company's clinical study is a non-significant risk (NSR) investigational device study under 812.3(m) of the investigational device exemptions (IDE) regulation (21 CFR 812). The CTLM system is limited by United States Federal Law to investigational use only in the United States. The CTLM system has received other registrations including CE, CMDCAS Canadian License, China SFDA, UL, ISO 9001:2000, ISO 13485:2003 and FDA export certification.