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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 Jan 20, 2023
The Trevo XP ProVue Retriever is a medical device specifically designed for removing thrombus in patients experiencing an ischemic stroke. This device is fully visible, which allows for better …
Published Jan 17, 2023 FDA Breakthrough Device Designation
Last Updated Jan 20, 2023
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 Jan 20, 2023
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 Jan 20, 2023
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 Jan 20, 2023
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 Jan 20, 2023
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 Jan 20, 2023
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 Jan 20, 2023
Lets you breeze through X-ray procedures. Most common tasks are done in two clicks or less. Built-in X-ray sequences allow taking series with the fewest holder changes. When the sensor detects …
Published Jul 20, 2022 Imaging Software Dental Photography
Last Updated Jan 19, 2023
When software robots take on the thousands of detailed, repetitive tasks and processes, it makes everyone in the healthcare system patients, partners, caregivers, administrators, and communities feel …
Published Oct 20, 2021 Robotic Process Automation
Last Updated Jan 18, 2023
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