Healthdyne Technologies announces FDA clearance for Quantum(TM).MARIETTA, Ga.--(BUSINESS WIRE)--September 29, 1995--Healthdyne Technologies, Inc. (Nasdaq:HDTC HDTC Humanitarian Demining Training Center HDTC Holding Down the Couch (webcomic) HDTC Hornchurch Drum & Trumpet Corps (UK) ) announced today it has received marketing clearance from the United States Food and Drug Administration United States Food and Drug Administration (FDA), n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. (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. ) to market QuantumTM, a new non-invasive, bi-level ventilator developed by the Company. This will allow the Company to begin selling the product to the acute, sub-acute and home care markets commencing in the fourth quarter of this year. QuantumTM is a cost effective alternative to many traditional ventilation modalities which require the costly and traumatic procedure of intubation intubation /in·tu·ba·tion/ (in?too-ba´shun) the insertion of a tube into a body canal or hollow organ, as into the trachea. endotracheal intubation . This new product is intended to provide pressure support ventilation to adult patients and allow treatment in not only the acute care setting, but also in the less expensive sub-acute and home care settings. Commenting on the clearance, Craig B. Reynolds, President and Chief Executive Officer, stated, "We are pleased with the FDA's clearance of our application to market our non-invasive ventilator. Healthdyne Technologies has again demonstrated its ability to efficiently move innovative products through the development process to market introduction." Reynolds continued, "We are optimistic about the market potential for QuantumTM. We believe QuantumTM will substantially reduce the total cost associated with obstructive airway diseases, while enhancing the patient's compliance and quality of life during treatment. The addition of innovative and higher margin products such as QuantumTM to our existing product lines will strengthen our ability to meet our customer needs, improve our gross profit margin Gross profit margin Gross profit divided by sales, which is equal to each sales dollar left over after paying for the cost of goods sold. gross profit margin A measure calculated by dividing gross profit by net sales. and allow us to leverage our distribution infrastructure." Healthdyne Technologies designs, manufactures and markets technologically advanced medical devices primarily for use in the home, as well as in specialized clinical settings. The Company's products include diagnostic and therapeutic devices for the evaluation and treatment of sleep disorders Sleep Disorders Definition Sleep disorders are a group of syndromes characterized by disturbance in the patient's amount of sleep, quality or timing of sleep, or in behaviors or physiological conditions associated with sleep. , oxygen concentrators and medication nebulizers for the treatment of respiratory disorders, monitors for infants at risk for SIDS SIDS sudden infant death syndrome. SIDS abbr. sudden infant death syndrome SIDS, n See syndrome, sudden infant death. , and products for asthma management. CONTACT: M. Wayne Boylston, 770/499-1212 |
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