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The Paige Prostate Suite is a set of AI applications designed to assist pathologists in the detection and diagnosis of prostate cancer. The suite includes Paige Prostate Detect, Paige Prostate Grade ā¦
Published Jan 24, 2023 FDA Breakthrough Device Designation
Last Updated
The ELFā¢ Test is a non-invasive blood test that can be performed on AtellicaĀ® IM Analyzer and ADVIA CentaurĀ® Immunoassay systems. It measures three markers of fibrosis in the liver: hyaluronic acid ā¦
Published Jan 24, 2023 FDA Breakthrough Device Designation
Last Updated
NightWare is a prescription digital therapeutic device that has been designated as a Breakthrough Device by the FDA in 2020. This designation is given to new treatments that address life-threatening ā¦
Published Jan 20, 2023 FDA Breakthrough Device Designation
Last Updated
The INTERCEPT Blood System for Plasma is a pathogen reduction system that has been designed to reduce the risk of transfusion-transmitted infections (TTI) and transfusion-associated graft-versus-host ā¦
Published Jan 20, 2023 FDA Breakthrough Device Designation
Last Updated
The aprevo spine fusion device by Carlsmed is a product that utilizes patient data and digital technologies to create personalized surgical plans and devices for each individual patient. Carlsmed aims ā¦
Published Jan 20, 2023 FDA Breakthrough Device Designation
Last Updated
The AltuMED PracticeFit is a software designed to assist healthcare providers in the financial aspect of their practice. The software conducts thorough checks on the financial eligibility of patients, ā¦
Published Jan 20, 2023 Application Programming Interface (APIs)
Last Updated
The MiniMedā¢ 770G system is a device that aims to aid in the management of diabetes. It offers features that can help to improve the quality of sleep and rest for users. Additionally, the system ā¦
Published Jan 19, 2023 FDA Breakthrough Device Designation
Last Updated
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 ā¦
Published Jan 19, 2023 FDA Breakthrough Device Designation
Last Updated
The cobasĀ® 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 ā¦
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 ā¦
Published Jan 18, 2023 FDA Breakthrough Device Designation
Last Updated
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