FDA allows Base Ten Systems to immediately market Prenval 1; first product of this type to come before the FDA for clearance.TRENTON, N.J.--(BUSINESS WIRE)--Sept. 21, 1995--Base Ten Systems Inc. (Nasdaq NM: BASEA BASEA Boston Area Solar Energy Association ) announced today that it has received formal written notification from the 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. allowing the company to immediately begin marketing PRENVAL(TM) 1 as described in the company's 510(k) premarket notification. PRENVAL(TM) 1 is a software computer program to assist in the database management, calculation of Multiple of the Median (MoM) and generation of reports from quantitative measurement of Alpha-fetoprotein (AFP (1) (AppleTalk Filing Protocol) The file sharing protocol used in an AppleTalk network. In order for non-Apple networks to access data in an AppleShare server, their protocols must translate into the AFP language. See file sharing protocol. ). Maternal serum Alpha-fetoprotein (MSAFP MSAFP Maternal Serum Alpha-Fetoprotein ) and amniotic fluid Alpha-fetoprotein (AFAFP) screening for the detection of fetal abnormalities and abnormal pregnancies have been used for over twenty years by obstetricians and geneticists. Abnormal MSAFP and AFAFP levels are associated with a number of fetal abnormalities, including open neural tube defects Neural tube defects A group of birth defects that affect the backbone and sometimes the spinal chord. Mentioned in: Birth Defects such as spina bifida and anencephaly anencephaly /an·en·ceph·a·ly/ (an?en-sef´ah-le) congenital absence of the cranial vault, with the cerebral hemispheres completely missing or reduced to small masses.anencephal´ic an·en·ceph·a·ly n. , congenital nephrosis nephrosis (nəfrō`səs), kidney disease characterized by lesions of the epithelial lining of the renal tubules, resulting in marked disturbance in the filtration function and the consequent appearance of large amounts of protein (albumin) , gastrointestinal tract abnormalities, and other gestational defects. Mike Kranzler, chairman and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. said "We are delighted to finally have reached the point where we can market and sell PRENVAL(TM) 1, the first product of this type to come before the FDA for clearance. We believe our success in this new software regulatory environment is based on the thoroughness of our design, the in depth documentation we provided, and the development of this product as if it were of the highest risk. "Our plans are to commence the implementation of our marketing and sales plan by informing clinical and laboratory facilities across the nation that this product is now available and to expand the number of forms in which it can be offered. PRENVAL(TM) 1 is the first of a family of products we intend to develop using the same safety critical software techniques that characterize all of our Medical Technology products. It represents an outstanding example of a commercial product generated from the successful transition of a defense technology culture. "It is important to note that PRENVAL(TM) 1 is built from a standard proprietary software structure. For other medical applications, we will be able to use the same structure to further serve the health care community." Base Ten Systems Inc. is a diversified technology company dedicated to providing safety critical products to the medical, manufacturing and weapons industries. CONTACT: Base Ten Systems Inc., Trenton Edward J. Klinsport, 609/586-7010 or Strategic Growth International Inc. Richard E. Cooper, 516/829-7111 |
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