Exero Medical Gets FDA Breakthrough Status for Internal Tissue Sensor

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.