Israeli medical device earns ‘Breakdown Specification’ status from FDA

Israeli developer Exero Medical – whose focus is on designing wireless systems for early detection of anastomotic (AL) leaks after gastrointestinal (GI) surgery – received FDA Breakthrough designation for the AL- he stops. FDA Breakthrough Specification status stands for medical devices capable of providing more effective treatment or diagnosis of potentially life-threatening illnesses or diseases. “In the world of early detection of AL, there is currently no technology that gives clinicians an insight into the state of intra-patient healing after surgical resection in the GI,” said Exero Medical CEO Erez Shor, PhD “The time it takes today to make a definitive diagnosis of a leak often puts the patient in a critical state of health.” On the other hand, some surgeons prescribe invasive interventions as a step. precautionary, putting patients through unnecessary additional procedures. Our system is also designed to provide clinicians with the data they need on thin healing before a patient reaches a catastrophic situation, enabling more accurate and effective intervention. , reducing problems and potentially saving lives. ”While Exero’s intelligent sensory innovation may help in the early detection of potentially fatal AL after GI surgery, the FDA has criticized Exero’s preclinical trial data from animal studies and the clinical data collected from the human test at Rabin Medical Center. “We are thrilled to be working with the FDA to maximize our regulatory process. I expect the rapid interaction with the FDA will reduce our time to market,” Shor said. “Erez and his team have developed life-saving technology using its multidisciplinary approach to medical device development that will have a significant impact on the GI surgery market,” added MEDX Xelerator CEO Shai Policker. meeting the FDA’s breach specification at this stage highlights the quality of their initial R&D and the urgent need for this technology to reach the hands of clinicians. “