Smart Oxygen Solutions’ Supplemental Oxygen Delivery Device Supasses FDA Regulatory Pathway Milestone
ieCrowd™ recently announced the achievement of a crucial milestone in the commercial advancement of Smart Oxygen, the firm’s supplemental oxygen delivery device. The Smart Oxygen device is being advanced by ieCrowd’s subsidiary Smart Oxygen Solutions and has the ability to automatically adjust to the patient’s need for oxygen, even if those demands are constantly changing, through analyzing the level of activity. The FDA announced that the 510 (k) submission for the Smart Oxygen device would need several technical bench and laboratory performance tests, but that no clinical study would have to be performed. This simplified submission, in comparison to a submission including clinical trials, corroborates the expected timeline in order to have Smart Oxygen Solutions commercially available in the first months of 2016. During a technical review meeting, the regulatory pathway was explained.
Smart Oxygen is designed to be used by patients who require supplemental oxygen such as those suffering with advanced COPD (Chronic Obstructive Pulmonary Disease). COPD is the third most common cause of death in the United States and estimates say that 14.8 million people are diagnosed patients and almost 12 million remain undiagnosed. In China, COPD is the second leading cause of death.
ieCrowd’s Smart Oxygen system has the capability of adjusting the level of supplemental oxygen that is being delivered to a patient automatically, utilizing a breath-to-breath basis. The device utilizes a new algorithm that is patent-pending and allows the device to deliver a specific dose of oxygen in response to the respiratory pattern that the patient is manifesting. By enabling the device’s ability to respond to a patient’s metabolic alterations and demands for oxygen, the patient in turn will receive the appropriate amount of oxygen when performing activities such as walking, climbing stairs or any other type of effort. The company expects that this automation will maintain satisfactory blood oxygen levels without the need to manually adjust the oxygen flow rate, and ultimately a more dynamic lifestyle and increased mobility for patients could be achieved and better exercise performance and quality of life would be granted to these patients.
The technology used was licensed from the University of California, San Diego by Smart Oxygen Solutions; the original device was developed there by researchers. Since then, Smart Oxygen Solutions has assembled a team of researchers from UC San Diego that are experts on pulmonary medicine, lung physiology, and chronic advanced lung disease treatment to report feedback on the safety and effectiveness of the Smart Oxygen device.
“Pulmonary rehabilitation (PR) programs have been shown to improve exercise capacity, quality of life, and dyspnea in patients with pulmonary disorders, such as chronic obstructive pulmonary disease (COPD). It is our hope that technologies like Smart Oxygen will advance the oxygen therapy field and help improve treatment in many pulmonary patients,” explained Xavier Soler, who is the Associate Medical Director of the Pulmonary Rehabilitation Program at UC San Diego and also Chief Medical Advisor to Smart Oxygen Solutions.