Exero Medical Announces Smart Sensor Granted FDA Breakthrough Designation

VERITAS Vision System Is Introduced by Johnson & Johnson

The company will offer live demos of the new system in a wet lab at the Johnson & Johnson booth (#2813) this weekend at the 2021 American Society of Cataract and Refractive Surgery and American Society of Ophthalmic Administrators Annual Meeting.

GenesisCare Orders 27 Elekta Flexitron Treatment Devices

"GenesisCare continues to demonstrate its commitment to improving patient outcomes worldwide and Elekta is delighted to play a vital partnering role to achieve this mission," said Gustaf Salford, Elekta's President and CEO.

FoodMarble AIRE Shown to Exceed the Performance of ‘Gold Standard’ SIBO Testing in Clinical Trial

SIBO is a very common disorder where there are excessive bacteria present in the small intestine. The true prevalence of SIBO in the general population is largely unknown, with some studies estimating its occurrence in up to 15% of healthy individuals. It is also largely associated with many other common clinical conditions, including irritable bowel syndrome, where 40-80% of IBS patients have SIBO.

December 15, 2020

Exero Medical, is a developer of a wireless system for early detection of anastomotic leaks (AL) following gastrointestinal (GI) surgery.

Exero Medical today announced that it has been granted FDA Breakthrough Designation, a status reserved for medical devices that provide more effective treatment or diagnosis of potentially life-threatening or irreversible conditions or diseases.

To achieve this status, Exero Medical demonstrated that its smart sensor for the early detection of potentially lethal AL following GI surgery represents a breakthrough that may demonstrate substantial improvement over any available solution.

“In the realm of early detection of AL, there is currently no technology that offers clinicians insights on the state of a patient’s internal tissue healing following resection surgery in the GI,” explained Erez Shor, PhD., CEO of Exero Medical. “The time needed today to obtain definitive diagnosis of a leak often puts the patient in a critical state of health. Alternatively, some surgeons order invasive interventions as a precautionary step, putting patients through often-unnecessary additional procedures. Our system is designed to provide clinicians the needed data on tissue healing well before a patient reaches a catastrophic situation, enabling more precise and effective intervention, minimizing complications and potentially saving lives.”

To confirm that Exero’s smart sensor may provide effective early diagnosis of AL, the FDA scrutinized the company’s pre-clinical data from its animal studies as well as clinical data collected in the first in-human feasibility trial conducted at Rabin Medical Center.

“We are thrilled to work with the FDA to optimize our regulatory process. I expect the rapid interaction with FDA will reduce our time to market,” added Shor.”

“Erez and his team have developed a life-saving technology using a multi-disciplinary approach to medical device development that will have a significant impact on the GI surgical market,” said Shai Policker, CEO of MEDX Xelerator. “Achieving the FDA’s Breakthrough Designation at this stage attests to the quality of their initial R&D and the urgent need for this technology to reach the hands of clinicians.”

Exero Medical is a portfolio company of MEDX Xelerator, a medical device and digital health focused incubator based in Israel, formed as a partnership between Boston Scientific, MEDX Ventures and Sheba Medical Center.

spot_img

DON'T MISS

Our Sister Publication: Biotechnology News Magazine

Subscribe to Medical Device News Magazine here.