Cell Robotics International receives approval from FDA for clinical testing of Lasette laser finger perforator.ALBUQUERQUE, N.M.--(BUSINESS WIRE)--Oct. 28, 1996--Cell Robotics International Inc. (OTC OTC See: Over-the-counter. OTC See over-the-counter market (OTC). :CRII CRII Cooperative Research in Information Infrastructure CRII Customer Returns Improvement Initiative ) has received final approval for an investigational device exemption An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to Food and (IDE) for a clinical study of the Cell Robotics' Lasette, a laser finger perforator per·fo·rate v. per·fo·rat·ed, per·fo·rat·ing, per·fo·rates v.tr. 1. To pierce, punch, or bore a hole or holes in; penetrate. 2. . The Lasette is used for sampling capillary blood for glucose and other blood chemistry readings. Clinical trials were initiated under an FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. conditional IDE granted Aug. 26, 1996, and are currently underway. FDA approval came after Cell Robotics made some small agreed-upon changes to the testing protocol. The 510K submission is planned for November 1996. Additional Lasette marketing studies undertaken by GEM Edwards Inc. at clinics, including the Cleveland Clinic, and by Cell Robotics at the University of New Mexico The University of New Mexico (UNM) is a public university in Albuquerque, New Mexico. It was founded in 1889. It also offers multiple bachelor's, master's, doctoral, and professional degree programs in all areas of the arts, sciences, and engineering. Hospital's Diabetic Educators, have indicated the existence of larger hospital, institutional, clinic, and professional markets than previously anticipated. Although the reduction in pain to the patient is important, marketing discussions have indicated that the major driving force from the professional medical community is the elimination of accidental finger sticks and the possibility of cross contamination from the patient to the health professional. By using products that reduce the possibility of cross contamination, medical facilities are able to avoid significant liability. Cell Robotics and Big Sky Laser Technologies, of Bozeman, Mont., have finalized the basic pre-production design of the Lasette. Twenty to 50 preproduction prototypes will be constructed by the end of the year. The current engineering prototype of Lasette is 7" x 3-1/2" x 1-1/2" and easily fits into a small notebook, similar to a daily planner. CONTACT: Cell Robotics International Inc. Craig T. Rogers, 719/590-1793 or Coffin * KCSA William F. Coffin, Rachel Reynolds or Bryan G. Crane, 818/789-0100 |
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