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@ShahidNShah
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The OraQuick® Ebola Rapid Antigen Test is an in-vitro diagnostic test designed for the detection of antigens from viruses within the Ebolavirus genus. The test is intended for use with venipuncture …
Published Jan 17, 2023 FDA Breakthrough Device Designation
Last Updated
The EXALT Model D is a single-use duodenoscope, which is designed to provide high performance and eliminate infection risk due to cross-contamination from ineffective reprocessing while also reducing …
Published Jan 17, 2023 FDA Breakthrough Device Designation
Last Updated
FoundationOne CDx is a tissue-based companion diagnostic (CDx) that has been clinically and analytically validated for all solid tumors, and has been approved by the FDA. The test provides physicians …
Published Jan 16, 2023 FDA Breakthrough Device Designation
Last Updated
Insightec is a company that has developed a Focused Ultrasound platform called Exablate Neuro, which is designed to treat Essential Tremor and Parkinson’s Disease. This platform utilizes up to …
Published Jan 16, 2023 FDA Breakthrough Device Designation
Last Updated
The Banyan BTITM is an in vitro diagnostic assay that uses the chemiluminescent enzyme-linked immunosorbent assay (ELISA) technique to provide a semi-quantitative measurement of the concentrations of …
Published Jan 16, 2023 FDA Breakthrough Device Designation
Last Updated
reSET-O is a Prescription Digital Therapeutic (PDT) for the treatment of Opioid Use Disorder (OUD) that received Breakthrough Designation and was authorized by the FDA in December 2018. The 84-day …
Published Jan 16, 2023 FDA Breakthrough Device Designation
Last Updated
IDx-DR is an AI diagnostic system that autonomously diagnoses patients with diabetic retinopathy (including macular edema). It provides diagnostic results at the point-of-care, eliminating the need …
Published Jan 16, 2023 FDA Breakthrough Device Designation
Last Updated
The AVITA Medical RECELL® System is a device used by healthcare professionals to treat acute thermal burns. The device allows for the production of a suspension of Spray-On Skin™ Cells using a small …
Published Jan 16, 2023 FDA Breakthrough Device Designation
Last Updated
Truveta Studio is a data and analytics solution that aims to study patient care and outcomes across all conditions, drugs and medical devices. The product utilizes AI-powered normalization and …
Published Jan 13, 2023 Analytics & Big Data
Last Updated
The TCARE Assist Caregiver Support Platform is a platform-as-a-service (PaaS) solution for organizations that aims to address the issue of caregiver burnout. The platform offers a range of features to …
Published Jan 13, 2023 Digital Assistant Caregivers
Last Updated
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