Strados Labs Secures Another FDA Clearance For its Electronic Stethoscope Technology
Strados Labs, a Philadelphia-based medical technology company, has received Food and Drug Administration clearance for the home use of its RESP respiratory monitoring system.
The 6-year-old company called the FDA clearance, its second in less than 18 months, a “major milestone” because it will allow the product to be used by patients in their homes for the remote monitoring of symptoms associated with pulmonary disease. It can also be used in teleheath connections between patients and their doctors.
The FDA initially approved the use of the device in health care settings in December 2020.
The company’s RESP smart sensor technology has the ability to detect lung sounds associated with events like heart failure, chronic obstructive pulmonary disease (COPD), asthma, and infectious diseases like Covid-19.
Dr. Mitchell Glass, chief medical officer at Strados, noted more than 5 million patients are discharged from hospitals each year with a primary diagnosis of asthma, COPD or heart failure.
“More than 30 million patient visits each year can be improved, or avoided entirely, by adding real time remote auscultation to the tools of the caregiver who has ready access to the patient’s RESP archive for comparison,” Glass said.
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