BALTIMORE, MD, UNITED STATES, January 21, 2025 /EINPresswire.com/ -- Linshom Medical announced today U.S. Food and Drug Administration, 510(k), clearance of the company’s two-piece, wearable respiratory sensor.
This clearance brings Linshom Medical closer to commercial launch of a product that has proven to provide clinicians 12 minutes advance notice of respiratory decline in an NIH funded clinical study at Ohio State University.
Lack of continuous respiratory monitoring is a major clinical problem as nearly half of all adverse events in hospitalized patients occur on the general care floor where respiratory monitoring consists of intermittent nursing checks every 4-8 hours, leaving patients unmonitored for most of their hospital stay. Clinical deterioration can be missed or belatedly recognized when the patient is in crisis.
“This is Linshom Medical’s second FDA clearance; a major strategic milestone enabling the company’s razor / razor-blade business strategy”, says CEO Richard Hughen.
The AI enabled Linshom Medical sensor provides clinical staff an accurate measure of respiratory rate (RR), seconds since last breath (SSLB) and relative tidal volume (rVt). Tidal volume is a critical parameter previously unavailable to non-intubated patients. These parameters at the bedside provide predictive, advance notice when clinical intervention is simple and inexpensive. This compared to late, reactive alarms that can result in expensive rapid response activations, rescue events (codes), ICU transfers and sometimes death.
About Linshom Medical:
Linshom (“to breathe”) Medical is first to deliver an operating room quality respiratory profile to the patient bedside (or home) for continuous, predictive respiratory monitoring (CPRM). Our AI enabled, patented and FDA cleared device provides a predictive (vs. responsive) respiratory profile to clinicians including Respiratory Rate (RR), relative Tidal Volume (rTV) and Seconds Since Last Breath (SSLB) that are all delivered continuously and in real time. Our mission is to eliminate the morbidity, mortality and expense due to unrecognized respiratory decline in healthcare. For more information, visit www.LinshomForLife.com.
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Richard Hughen
Linshom Medical
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