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FoundationOne Liquid CDx is a diagnostic tool that utilizes a simple blood draw to analyze over 300 genes recommended by guidelines. It is the only FDA-approved liquid biopsy that analyzes this many …
Published Jan 19, 2023 FDA Breakthrough Device Designation
Last Updated Jan 20, 2023
The Guardant360 CDx test is a genomic testing option for solid cancers that has been approved by the FDA. It provides doctors with comprehensive results within a week of a simple blood draw, which …
Published Jan 18, 2023 FDA Breakthrough Device Designation
Last Updated Jan 20, 2023
The cobas® EBV test is a diagnostic tool used by healthcare professionals to assess the risk of infection in transplant patients. The test is designed to provide reliable, standardized, and …
Published Jan 18, 2023 FDA Breakthrough Device Designation
Last Updated Jan 20, 2023
Barostim is a new therapy option for those suffering from heart failure that utilizes natural sensors in the body to regulate the heart. It is not a pacemaker or defibrillator. The therapy has been …
Published Jan 18, 2023 FDA Breakthrough Device Designation
Last Updated Jan 20, 2023
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 Jan 20, 2023
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
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