Exero Medical Gets FDA Breakthrough Status for Internal Tissue Sensor

FDA news

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.

https://www.fdanews.com/articles/200554-exero-medical-gets-fda-breakthrough-status-for-internal-tissue-sensor