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Home » Exero Medical Gets FDA Breakthrough Status for Internal Tissue Sensor
Exero Medical Gets FDA Breakthrough Status for Internal Tissue Sensor
December 21, 2020
Exero Medical announced that it has been granted a Breakthrough Device designation by the FDA for a wireless sensor designed for patients who have undergone gastrointestinal surgery.
The “smart sensor” detects the early occurrence of leaks following gastrointestinal surgeries, offering insight into a patient’s internal tissue healing after resection surgery.
The FDA granted the designation based on pre-clinical data from animal studies and clinical data collected in its first in-human feasibility trial.
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