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CMS noted in its announcement that the pathway is voluntary. Participating device makers would get access to CMS officials before FDA market authorization. The officials would review early evidence, …
Posted Jun 24, 2023 FDA Breakthrough Device Designation
The canturio™te is equipped with advanced sensors that generate detailed data to aid in post-surgical care following a total knee arthroplasty (TKA). This information helps patients and their …
Published Feb 1, 2023 FDA Breakthrough Device Designation
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aScope Duodeno is a one-time use duodenoscope for ERCP procedures. It provides a solution to the issue of patient cross-contamination that arises from traditional duodenoscopes that require …
Published Jan 31, 2023 FDA Breakthrough Device Designation
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The Philips IVC Filter Removal Laser Sheath - CavaClear - is a highly innovative medical device, specially designed for the removal of embedded IVC filters. It has been granted the Breakthrough Device …
Published Jan 30, 2023 FDA Breakthrough Device Designation
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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
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The Tula System is a medical device that has been approved by the FDA for use in patients aged six months and older. It utilizes a technique called iontophoresis to apply a low-level electrical charge …
Published Jan 28, 2023 FDA Breakthrough Device Designation
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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
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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
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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
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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
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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
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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
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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 …
Published Jan 24, 2023 FDA Breakthrough Device Designation
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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
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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
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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
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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
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The i-STAT Alinity is a portable blood analyzer that uses proven technology from the i-STAT 1 System to deliver real-time, lab-quality diagnostic test results. It features an intuitive interface that …
Published Jan 24, 2023 FDA Breakthrough Device Designation
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The PoNS device is a medical technology that helps individuals with chronic neurological symptoms caused by disease or trauma. It consists of a controller and a mouthpiece that delivers mild …
Published Jan 24, 2023 FDA Breakthrough Device Designation
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The Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave C2 Coronary IVL Catheter is a medical device that is indicated for the low-pressure balloon dilatation of severely calcified, …
Published Jan 24, 2023 FDA Breakthrough Device Designation
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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 …
Published Jan 20, 2023 FDA Breakthrough Device Designation
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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 …
Published Jan 20, 2023 FDA Breakthrough Device Designation
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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 …
Published Jan 20, 2023 FDA Breakthrough Device Designation
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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
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The MiniMed™ 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 …
Published Jan 19, 2023 FDA Breakthrough Device Designation
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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
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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
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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
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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
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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
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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
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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
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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
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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
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The Banyan BTITM is an in vitro diagnostic assay that uses the chemiluminescent enzyme-linked immunosorbent assay (ELISA) technique to provide a semi-quantitative measurement of the concentrations of …
Published Jan 16, 2023 FDA Breakthrough Device Designation
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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
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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
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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
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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
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Embrace2 is the only FDA-cleared wrist-worn wearable in epilepsy. It detects possible convulsive seizures and instantly alerts caregivers, whether they are sleeping next door or are living miles away. …
Published Jan 1, 2022 Remote Patient Monitoring Disease Management Wearables FDA Breakthrough Device Designation
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