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gel-e

Gel-e gains breakthrough device nod for internal bleeding control device

June 18, 2019 By Nancy Crotti

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 […]

Filed Under: Biotech, Food & Drug Administration (FDA), News Well, Wound Care Tagged With: FDA, gel-e

Gel-E wins FDA OTC nod for gel-e Flex flowable hemostat

June 29, 2018 By Fink Densford

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 […]

Filed Under: 510(k), Food & Drug Administration (FDA), Regulatory/Compliance, Wound Care Tagged With: gel-e

20 medical device startups you need to know

April 13, 2018 By Chris Newmarker

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 […]

Filed Under: Business/Financial News, Cardiovascular, Drug-Device Combinations, Neuromodulation/Neurostimulation, News Well, Surgical Tagged With: 4cmedical, aspectbiosystems, Axonics Modulation Technologies, brainspec, cammed, clinicalsensors, cognitotherapeutics, dayzerodiagnostics, Eyenovia Inc., gel-e, Livongo, Medineering, metavention, patientory, portal instruments, prellisbiologics, reactiverobotics, rxfunction, sonexhealth, spryhealth, startups

Early-stage wound care dev Gel-e raises $3m

July 13, 2017 By Fink Densford

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 […]

Filed Under: Blood Management, Business/Financial News, Wound Care Tagged With: gel-e

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