Wound-care startup Gel-e said today that it has won FDA breakthrough status designation for its first internal-use flowable device. The College Park, Md.-based company’s first product, Life Foam, is an expanding, injectable hemostat designed to rapidly provide temporary control of bleeding from non-compressible abdominal wounds that are not suited to tourniquet application in trauma and battlefield […]
gel-e
Gel-E wins FDA OTC nod for gel-e Flex flowable hemostat
Early stage wound care company Gel-e said today it won FDA 510(k) clearance for its gel-e Flex as an over-the-counter flowable hemostat. The College Park, Md.-based company said the clearance expands the labeling for the local management of lacerations and minor bleeding, and said the products were specifically designed to be usable by both trained professionals and […]
20 medical device startups you need to know
There’s a lot of excitement these days around digital health. But there are actually many medical device startups out there in other spaces that continue to push the overall boundaries of medtech. From neuromodulation to drug delivery, surgical robotics and more, here’s a roundup of 20 medical device startups catching the eye of Medical Design […]
Early-stage wound care dev Gel-e raises $3m
Early stage wound care company Gel-e said today it raised $3.1 million to support its hemostatic and wound care platform. The round was led by unnamed early-stage investment funds and life science investors, the College Park, Md.-based company said. Gel-e said that financing will help support initial FDA clearance for products designed to manage bleeding […]
