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@ShahidNShah
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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
The cobas® BKV test is a diagnostic tool that aims to provide reliable and standardized results for improved management of transplant patients at risk of infection. It is used to assess if transplant …
Published Jan 19, 2023
Last Updated
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
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
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
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
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
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