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EYE-SYNC® technology is a tool that measures the synchronization abilities of the eyes. It is designed to identify the quality of performance when interacting with visual cues and synchronizing eye …
Published Jan 25, 2023 FDA Breakthrough Device Designation
Last Updated Jan 25, 2023
Koios DS is a software that uses artificial intelligence to analyze ultrasound images and provide cancer risk assessments. The software is built on an ensemble of algorithms that have been trained on …
Published Jan 25, 2023 FDA Breakthrough Device Designation
Last Updated Jan 25, 2023
Agili-C™ is a cell-free, off-the-shelf implant that is designed to be used in cartilage and osteochondral defects in traumatic and osteoarthritic joints. The implant is made of a porous, …
Published Jan 25, 2023 FDA Breakthrough Device Designation
Last Updated Jan 25, 2023
RelieVRx (formerly EaseVRx) is the first and only FDA-authorized at-home immersive virtual reality (VR) pain treatment indicated as adjunctive treatment for chronic lower back pain (CLBP). RelieVRx is …
Published Dec 14, 2022 Virtual Reality FDA Breakthrough Device Designation
Last Updated Jan 25, 2023
The ELF™ Test is a non-invasive blood test that can be performed on Atellica® IM Analyzer and ADVIA Centaur® Immunoassay systems. It measures three markers of fibrosis in the liver: hyaluronic acid …
Published Jan 24, 2023 FDA Breakthrough Device Designation
Last Updated Jan 24, 2023
Paired VNS, a treatment for stroke survivors, aims to improve hand and arm function by stimulating the vagus nerve. The vagus nerve, the longest nerve in the body, is responsible for sending messages …
Published Jan 24, 2023 FDA Breakthrough Device Designation
Last Updated Jan 24, 2023
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 …
Published Jan 24, 2023 FDA Breakthrough Device Designation
Last Updated Jan 24, 2023
Canvas Dx is a software as a medical device (SaMD) that has been authorized by the FDA to aid physicians in diagnosing autism spectrum disorder (ASD) in young children. This technology utilizes …
Published Jan 24, 2023 FDA Breakthrough Device Designation
Last Updated Jan 24, 2023
The IpsiHand is a device designed to assist individuals with chronic stroke in their rehabilitation. It is the first FDA-cleared device that utilizes brain-computer interface technology to improve arm …
Published Jan 24, 2023 FDA Breakthrough Device Designation
Last Updated Jan 24, 2023
Harmony™ TPV is a new transcatheter valve system that has recently been granted FDA approval for the treatment of severe pulmonary regurgitation in patients with a native or surgically-repaired right …
Published Jan 24, 2023 FDA Breakthrough Device Designation
Last Updated Jan 24, 2023
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