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@ShahidNShah
@ShahidNShah
The Optimizer Smart and its successor, the Optimizer® Smart Mini, are minimally invasive, implantable devices that deliver a proprietary therapy to patients with heart failure. CCM® therapy is a …
Published Jan 28, 2023 FDA Breakthrough Device Designation
Last Updated Jan 28, 2023
The Spiration Valve System is an endobronchial therapy that is designed for patients with severe emphysema. It offers a minimally invasive treatment option for lung volume reduction and has a …
Published Jan 28, 2023 FDA Breakthrough Device Designation
Last Updated Jan 28, 2023
The CUSTOMFLEX® ARTIFICIALIRIS is a foldable iris prosthesis that is used for both medical and aesthetic reconstruction of eyes with complete or partial aniridia. The product is manufactured by …
Published Jan 28, 2023 FDA Breakthrough Device Designation
Last Updated Jan 28, 2023
The Univfy Report is a personalized tool that utilizes a scientifically validated model to predict a patient’s probability of success with IVF. The prediction model is customized for each center …
Published Jan 28, 2023 Data
Last Updated Jan 28, 2023
Zephyr Valves are proven to help emphysema patients breathe easier, be more active, and enjoy a better quality of life. The Zephyr Endobronchial Valve is an FDA-approved device for patients with …
Published Jan 1, 2022 General Care Management FDA Breakthrough Device Designation
Last Updated Jan 28, 2023
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
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