EndeavorOTC is a digital therapeutic indicated to improve attention function, ADHD symptoms, and quality of life in adults 18 years of age and older with primarily inattentive or combined-type ADHD. Please see the Instructions for Use for additional indication and safety information.EndeavorOTC is a digital, non-drug treatment delivered through an action video game that was shown to improve attention function in adults with ADHD. EndeavorOTC treatment is used on a mobile device. See page 6 for compatible devices. EndeavorOTC is different from action video games that you might play. The treatment programmed into the ...Apr 4, 2024 · EndeavorOTC is a digital therapeutic indicated to improve attention function, ADHD symptoms, and quality of life in adults 18 years of age and older with primarily inattentive or combined-type ADHD. Please see the Instructions for Use for additional indication and safety information. EndeavorOTC is a digital therapeutic indicated to improve attention function, ADHD symptoms and quality of life in adults 18 years of age and older with primarily inattentive or combined-type ADHD. EndeavorOTC utilizes the same proprietary technology underlying EndeavorRx, a prescription digital therapeutic indicated to …EndeavorOTC is a digital therapeutic indicated to improve attention function, ADHD symptoms, and quality of life in adults 18 years of age and older with primarily inattentive or combined-type ADHD. Please see the Instructions for Use for additional indication and safety information.EndeavorOTC is a digital therapeutic indicated to improve attention function, ADHD symptoms, and quality of life in adults 18 years of age and older with primarily inattentive or combined-type ADHD. Please see the Instructions for Use for additional indication and safety information.Akili Releases EndeavorOTC - Adult ADHD Treatment . London Stock Exchange. PURETECH HEALTH PLC. Released 12:05:01 07 June 2023 07 June 2023. London Stock Exchange plc is not responsible for and does not check content on this Website. Website users are responsible for checking content. Any news item (including …Nov 16, 2023 · EndeavorOTC is a digital therapeutic indicated to improve attention function, ADHD symptoms, and quality of life in adults 18 years of age and older with primarily inattentive or combined-type ADHD. Please see the Instructions for Use for additional indication and safety information. EndeavorOTC is available under the U.S. Food and Drug Administration’s current Enforcement Policy for Digital Health Devices for Treating Psychiatric Disorders During the Coronavirus Disease ...Jan 29, 2024 · EndeavorOTC is a digital therapeutic indicated to improve attention function, ADHD symptoms, and quality of life in adults 18 years of age and older with primarily inattentive or combined-type ADHD. Please see the Instructions for Use for additional indication and safety information. EndeavorRx: Indications, Safety and Cautions. Indications: EndeavorRx is a digital therapeutic indicated to improve attention function as measured by computer-based testing in children ages 8-17 years old with primarily inattentive or combined-type ADHD, who have a demonstrated attention issue.Jan 16, 2024 · EndeavorOTC is a digital ADHD treatment for adults, based on 10 years of ADHD research. Our teams include neuroscientists, cognitive scientists, and healthcare professionals who focus the design on the neurocognitive differences and needs of adults and children who have been diagnosed with ADHD. The treatment uses an adaptive algorithm designed ... About EndeavorOTC®: Outplay ADHD. EndeavorOTC®: Outplay ADHD falls under the category of Medical Apps, developed by Akili Interactive Labs, Inc.. It's been launched since September 2023. The app boasts 61 thousand installs. During the 30-day period ending today, EndeavorOTC®: Outplay ADHD accumulated roughly 3.1 …EndeavorOTC is a digital therapeutic indicated to improve attention function, ADHD symptoms, and quality of life in adults 18 years of age and older with primarily inattentive or combined-type ADHD. Please see the Instructions for Use for additional indication and safety information. EndeavorRx is an ADHD treatment for kids aged 8-17 . It’s delivered through an immersive video game experience on mobile devices. Created by world-class neuroscientists and award-winning game designers, it targets areas of the brain that play a key role in attention function . As an FDA-authorized medical device, EndeavorRx must be prescribed ... This subreddit is a space for women to find support and discuss living with ADHD. If you would like to contact the mods, send us a modmail instead of DM-ing the moderators directly.Dec 19, 2023 · EndeavorOTC is a digital therapeutic indicated to improve attention function, ADHD symptoms, and quality of life in adults 18 years of age and older with primarily inattentive or combined-type ADHD. Please see the Instructions for Use for additional indication and safety information. Akili today announced the official release of its new product, EndeavorOTC. The mobile game is a version of Akili’s similarly named, FDA-authorized EndeavorRX, built upon the same technology.EndeavorOTC for Adults. EndeavorOTC uses the EndeavorRx technology modified for adults with ADHD, and it does not require a prescription. A study of 220 adults using EndeavorOTC found improvements in ADHD-related symptoms, functional difficulties, and quality of life, the company said. 7, 8 EndeavorRx is a digital therapeutic indicated to improve attention function as measured by computer-based testing in children ages 8-17 years old with primarily inattentive or combined-type ADHD, who have a demonstrated attention issue. Patients who engage with EndeavorRx demonstrate improvements in a digitally assessed measure, Test of ... EndeavorOTC is a digital therapeutic indicated to improve attention function, ADHD symptoms, and quality of life in adults 18 years of age and older with primarily inattentive or combined-type ADHD. Please see the Instructions for Use for additional indication and safety information.EndeavorOTC is a digital therapeutic indicated to improve attention function, ADHD symptoms, and quality of life in adults 18 years of age and older with primarily inattentive or combined-type ADHD. Please see the Instructions for Use for additional indication and safety information.It's a video game that targets the parts of the brain involved in attention control. It's been in development for 10 years, went through clinical trials, and has been presented to the …Navigating Adult ADHD and Finding Focus. Medicine Doesn’t Have to be in Pill Form. A New Kind of ADHD Treatment. Treating ADHD with Tech. A Drug-free ADHD Treatment for AdultsNavigating Adult ADHD and Finding Focus. Medicine Doesn’t Have to be in Pill Form. A New Kind of ADHD Treatment. Treating ADHD with Tech. A Drug-free ADHD Treatment for AdultsThe intended use of a video game will dictate the way a game is designed and the way the game can affect the brain. Therefore, the processes for developing video games intended for entertainment and for those designed to change brain function or treat ADHD are quite different. For a video game created as a digital therapeutic, the primary …EndeavorOTC is an immersive mobile app designed for adults with ADHD to improve daily functioning. The app uses research-backed gamification to increase focus …Akili today announced the official release of its new product, EndeavorOTC. The mobile game is a version of Akili’s similarly named, FDA-authorized EndeavorRX, …Follow. SAN DIEGO, April 24, 2024 (GLOBE NEWSWIRE) -- Endeavor Bancorp (OTCQX: EDVR) (the “Company,” or “Bancorp”), the holding company for …EndeavorOTC is a digital therapeutic indicated to improve attention function, ADHD symptoms, and quality of life in adults 18 years of age and older with primarily inattentive or combined-type ADHD. Please see the Instructions for Use for additional indication and safety information.EndeavorOTC is a digital therapeutic indicated to improve attention function, ADHD symptoms, and quality of life in adults 18 years of age and older with primarily inattentive or combined-type ADHD. Please see the Instructions for Use for additional indication and safety information.Jan 16, 2024 · EndeavorOTC is a digital ADHD treatment for adults, based on 10 years of ADHD research. Our teams include neuroscientists, cognitive scientists, and healthcare professionals who focus the design on the neurocognitive differences and needs of adults and children who have been diagnosed with ADHD. The treatment uses an adaptive algorithm designed ... Apr 16, 2024 · Among EndeavorOTC users, 61% are taking medication for their ADHD alongside EndeavorOTC, and a quarter (25%) say they are trying EndeavorOTC because of difficulty obtaining their ADHD medication. Another reason people seek novel medical treatments like digital therapeutics or DTx is that even the gold-standard treatments for ADHD (medication ... EndeavorOTC is designed to help ADHD symptoms such as attention and function with its mobile video game. The first FDA-authorized game for ADHD, it uses the same technology as EndeavorRx, which helps children manage their symptoms.. When you start the game, you travel in a hovercraft around a colorful and electrifying environment.EndeavorOTC is a digital therapeutic indicated to improve attention function, ADHD symptoms, and quality of life in adults 18 years of age and older with primarily inattentive or combined-type ADHD. Please see the Instructions for Use for additional indication and safety information.EndeavorOTC is an evidence-based treatment that is designed to help you resist distraction and improve your focus naturally. Let’s start by understanding how adult learning compares to learning for kids. In the 1970s there was a prominent theory of adult learning (sometimes referred to as “andragogy,” as compared to “pedagogy” for ...Endeavor OTC is the adult version of Endeavor RX, the first video game to receive FDA approval as a treatment for ADHD. The video game targets the parts of the brain involved in attention control ...Follow. SAN DIEGO, April 24, 2024 (GLOBE NEWSWIRE) -- Endeavor Bancorp (OTCQX: EDVR) (the “Company,” or “Bancorp”), the holding company for …The game-based adult ADHD treatment designed to improve ADHD symptoms and focus. Download EndeavorOTC®: Outplay ADHD and enjoy it on your iPhone, iPad, and iPod touch. Start your subscription today to begin treatment with EndeavorOTC, the game-based ADHD treatment clinically designed to improve symptoms, attention and focus, designed with the same technology as the world’s first FDA-authorized game-based treatment. EndeavorOTC is a video game app clinically designed to treat and improve ADHD symptoms for adults, anytime, anywhere. Find your focus with a lasting impact t...EndeavorOTC is a digital therapeutic indicated to improve attention function, ADHD symptoms and quality of life in adults 18 years of age and older with primarily inattentive or combined-type ADHD.EndeavorOTC is a digital therapeutic indicated to improve attention function, ADHD symptoms, and quality of life in adults 18 years of age and older with primarily inattentive or combined-type ADHD. Please see the Instructions for Use for additional indication and safety information.Digital medicine company Akili has introduced a new immersive mobile video game treatment called EndeavorOTC to enhance attention in adults suffering from attention deficit hyperactivity disorder (ADHD).. EndeavorOTC is developed using the same technology as the company’s EndeavorRx, a prescription digital therapeutic indicated for …EndeavorRx is an FDA-authorized prescription digital therapeutic that targets cognitive processes involved in attention function. Powered by our patented Selective Stimulus Management Engine (SSME™) technology, EndeavorRx is personalized and adaptive. Patient progress is monitored and optimized in real time – it adjusts difficulty levels ...Digital medicine company Akili has introduced a new immersive mobile video game treatment called EndeavorOTC to enhance attention in adults suffering from attention deficit hyperactivity disorder (ADHD).. EndeavorOTC is developed using the same technology as the company’s EndeavorRx, a prescription digital therapeutic indicated for …EndeavorOTC for Adults. EndeavorOTC uses the EndeavorRx technology modified for adults with ADHD, and it does not require a prescription. A study of 220 adults using EndeavorOTC found improvements in ADHD-related symptoms, functional difficulties, and quality of life, the company said. 7, 8EndeavorRx is an ADHD treatment for kids aged 8-17 . It’s delivered through an immersive video game experience on mobile devices. Created by world-class neuroscientists and award-winning game designers, it targets areas of the brain that play a key role in attention function . As an FDA-authorized medical device, EndeavorRx must be prescribed ...EndeavorOTC is a digital therapeutic indicated to improve attention function, ADHD symptoms, and quality of life in adults 18 years of age and older with primarily inattentive or combined-type ADHD. Please see the Instructions for Use for additional indication and safety information.EndeavorOTC is a video game app clinically designed to treat and improve ADHD symptoms for adults, anytime, anywhere. Find your focus with a lasting impact …EndeavorOTC is a subscription-based mobile video game app clinically designed to. improve ADHD symptoms, functioning, and attention - anytime, anywhere. Built. with the same technology as the En... Rating 3.9/5. Votes 1,035. Recommended: But with caution. Table of Contents:Feb 7, 2024 · EndeavorOTC is a product built by parent company Akili – the same company that created EndeavorRx, the world’s first FDA–authorized prescription video game treatment for pediatric ADHD. As a digital therapeutic, EndeavorOTC was built by neuroscientists, cognitive scientists, clinical psychologists, and other healthcare professionals. EndeavorOTC is an immersive mobile app designed for adults with ADHD to improve daily functioning. The app uses research-backed gamification to increase focus …Is my focus better than last week? There’s an app for that! There are a lot of ways to treat and manage ADHD; however many options rely on gradual, subtle improvements, which can make it hard to understand if you’ve made progress. Often, the inability to understand or see progress is why we abandoBoth Rx and OTC are regulatory filings with the FDA, and they are different regulatory filings. We publicly announced recently t hat we'd continue moving towards an OTC/direct-to-consumer model because it better puts the treatment decision-making in the hands of the consumer (with hopefully support from their HCPs.)EndeavorOTC is a digital therapeutic indicated to improve attention function, ADHD symptoms, and quality of life in adults 18 years of age and older with primarily inattentive or combined-type ADHD. Please see the Instructions for Use for additional indication and safety information.EndeavorOTC is a digital therapeutic indicated to improve attention function, ADHD symptoms, and quality of life in adults 18 years of age and older with primarily inattentive or combined-type ADHD. Please see the Instructions for Use for additional indication and safety information.To be eligible, users must have 1) purchased an initial subscription via EndeavorOTC’s web-based payment platform (with payment via Stripe) or via the iOS App Store or Google Play on or after March 6th, 2024 and 2) played the EndeavorOTC treatment for at least 6 weeks, a minimum of 70 minutes per week for each of the 6 weeks, and 3) submitted ...Hello! Maybe this is just me, but I found that when I hold my 10.9" iPad Air (5th Gen) close to my face while playing, I started to do much better after my Focus Score started plateauing. I think it makes the "Navigation" component much easier in terms of being able to appropriately manipulate the accelerometer/gyroscope to be able to make ...About EndeavorOTC®: Outplay ADHD. EndeavorOTC®: Outplay ADHD falls under the category of Medical Apps, developed by Akili Interactive Labs, Inc.. It's been launched since September 2023. The app boasts 61 thousand installs. During the 30-day period ending today, EndeavorOTC®: Outplay ADHD accumulated roughly 3.1 …EndeavorOTC is a digital therapeutic indicated to improve attention function, ADHD symptoms, and quality of life in adults 18 years of age and older with primarily inattentive or combined-type ADHD. Please see the Instructions for Use for additional indication and safety information.Akili today announced the official release of its new product, EndeavorOTC. The mobile game is a version of Akili’s similarly named, FDA-authorized EndeavorRX, built upon the same technology.The intended use of a video game will dictate the way a game is designed and the way the game can affect the brain. Therefore, the processes for developing video games intended for entertainment and for those designed to change brain function or treat ADHD are quite different. For a video game created as a digital therapeutic, the primary …Sales of EndeavorOTC were $341,000 from its launch on June 6, 2023, through Sept. 5, with revenue per user averaging $82. Meanwhile, Akili's 2023 second quarter revenues were $114,000. Catch up quick: Akili last August went public after merging with Chamath Palihapitiya's Social Capital Suvretta Holdings Corp. SPAC.This June, Akili released EndeavorOTC, an “over-the-counter” version of the game for adults. It uses the same FDA-approved technology under the hood, ...The game-based adult ADHD treatment designed to improve ADHD symptoms and focus.EndeavorOTC is a digital therapeutic indicated to improve attention function, ADHD symptoms, and quality of life in adults 18 years of age and older with primarily inattentive or combined-type ADHD. Please see the Instructions for Use for additional indication and safety information.Indications, Safety and Cautions. EndeavorRx is a digital therapeutic indicated to improve attention function as measured by computer-based testing in children ages 8-17 years old with primarily inattentive or combined-type ADHD, who have a demonstrated attention issue. Patients who engage with EndeavorRx demonstrate improvements in a digitally ... EndeavorOTC is a digital therapeutic indicated to improve attention function, ADHD symptoms, and quality of life in adults 18 years of age and older with primarily inattentive or combined-type ADHD. Please see the Instructions for Use for additional indication and safety information. EndeavorOTC is a digital therapeutic indicated to improve attention function, ADHD symptoms, and quality of life in adults 18 years of age and older with primarily inattentive or combined-type ADHD. Please see the Instructions for Use for additional indication and safety information. EndeavorRx is a digital therapeutic indicated to improve attention function as measured by computer-based testing in children ages 8-17 years old with primarily inattentive or combined-type ADHD, who have a demonstrated attention issue. Patients who engage with EndeavorRx demonstrate improvements in a digitally assessed measure, Test of ... EndeavorRx is a digital therapeutic indicated to improve attention function as measured by computer-based testing in children ages 8-17 years old with primarily inattentive or combined-type ADHD, who have a demonstrated attention issue. Patients who engage with EndeavorRx demonstrate improvements in a digitally assessed measure, Test of ...Mar 21, 2024 · EndeavorOTC is for adults 18 years and older with ADHD experiencing inattention-related challenges that affect their quality of life such as diminished focus, inability to complete projects or tasks, keep track of important items, and more. Built with the same technology as EndeavorRx, the world's first FDA-authorized video game treatment. EndeavorOTC is a digital, non-drug treatment delivered through an action video game that was shown to improve attention function in adults with ADHD. EndeavorOTC treatment is used on a mobile device. See page 6 for compatible devices. EndeavorOTC is different from action video games that you might play. The treatment programmed into the ...EndeavorOTC Help or Questions. Feel free to comment with all of your questions here for the EndeavorOTC team. We can provide answers to questions about cognitive science, clinical data, instructions for use or optimizing use, product design, and more! 5 comments. Add a Comment.Oct 17, 2023 · Video game EndeavorOTC designed to treat ADHD 02:49. SACRAMENTO – For people who live with ADHD, the simplest tasks can be difficult. So playing video games might be the last thing you'd think ... About EndeavorRx and EndeavorOTC Akili’s suite of cognitive treatment products for ADHD includes EndeavorRx and EndeavorOTC ®. EndeavorRx is indicated to improve attention function as measured by computer-based testing in children ages 8 to 17 years old with primarily inattentive or combined-type ADHD, who have a demonstrated …Feb 7, 2024 · EndeavorOTC is a product built by parent company Akili – the same company that created EndeavorRx, the world’s first FDA–authorized prescription video game treatment for pediatric ADHD. As a digital therapeutic, EndeavorOTC was built by neuroscientists, cognitive scientists, clinical psychologists, and other healthcare professionals. EndeavorOTC is a subscription-based mobile video game app clinically designed to. improve ADHD symptoms, functioning, and attention - anytime, anywhere. Built. with the same technology as the En... Rating 3.9/5. Votes 1,035. Recommended: But with caution. Table of Contents:The game-based adult ADHD treatment designed to improve ADHD symptoms and focus.Sep 20, 2023 · Is my focus better than last week? There’s an app for that! There are a lot of ways to treat and manage ADHD; however many options rely on gradual, subtle improvements, which can make it hard to understand if you’ve made progress. EndeavorOTC Help or Questions. Feel free to comment with all of your questions here for the EndeavorOTC team. We can provide answers to questions about cognitive science, clinical data, instructions for use or optimizing use, product design, and more! 5 comments. Add a Comment.EndeavorOTC has not been cleared or authorized by the U.S. Food and Drug Administration for any indications. It is recommended that patients speak to their health care provider before starting ...This subreddit is a space for women to find support and discuss living with ADHD. If you would like to contact the mods, send us a modmail instead of DM-ing the moderators directly.EndeavorOTC is for adults 18 years and older with ADHD experiencing inattention-related challenges that affect their quality of life such as diminished focus, inability to complete projects or tasks, keep track of important items, and more. Built with the same technology as EndeavorRx, the world's first FDA-authorized video game treatment.EndeavorRx is an ADHD treatment for kids aged 8-17 . It’s delivered through an immersive video game experience on mobile devices. Created by world-class neuroscientists and award-winning game designers, it targets areas of the brain that play a key role in attention function . As an FDA-authorized medical device, EndeavorRx must be prescribed ...EndeavorOTC is a digital therapeutic indicated to improve attention function, ADHD symptoms, and quality of life in adults 18 years of age and older with primarily inattentive or combined-type ADHD. Please see the Instructions for Use for additional indication and safety information.@EndeavorOTC @EndeavorOTC. Game-based ADHD treatment to improve ADHD-related symptoms and focus for adults. Download on the App Store. Get it on Google …
EndeavorOTC is a digital therapeutic indicated to improve attention function, ADHD symptoms, and quality of life in adults 18 years of age and older with primarily inattentive or combined-type ADHD. Please see the Instructions for Use for additional indication and safety information.. Prociyum
Royal Gold Inc. 0.88%. $8B. Comstock Inc. -8.52%. $38.87M. EDVMF | Complete Endeavour Mining PLC stock news by MarketWatch. View real-time stock prices and stock quotes for a full financial overview.© 2023 Akili Interactive Labs, Inc. All rights reserved. Terms of Use | Privacy Notice | Privacy NoticeWhen Akili Interactive’s EndeavorRx (AKL-T01) game was approved in June 2020, it became the very first video game to be approved by the US Food and Drug Administration (FDA) for any type of condition. EndeavorRx falls into a category of products called digital therapeutics. It is for use in children aged 8-12 years old with primarily ...Among EndeavorOTC users, 61% are taking medication for their ADHD alongside EndeavorOTC, and a quarter (25%) say they are trying EndeavorOTC because of difficulty obtaining their ADHD medication. Another reason people seek novel medical treatments like digital therapeutics or DTx is that even the gold-standard treatments for …EndeavorOTC is a new treatment option for adults with ADHD that can improve the brain’s mental processes related to inattention and ADHD symptoms in addition to, or without the need for, medication. However, much like going to the gym, this treatment requires commitment to regular usage and at least four to six weeks of initial treatment to ...EndeavorOTC is a digital, non-drug treatment delivered through an action video game that was shown to improve attention function in adults with ADHD. EndeavorOTC treatment is used on a mobile device. See page 6 for compatible devices. EndeavorOTC is different from action video games that you might play. The treatment programmed into the ...Jun 7, 2023 · In this video, I reflect on the new EndeavorOTC, the new video game therapy for ADHD, released by Akili Interactive, now for ADULTS! EndeavorOTC is a compute... Among EndeavorOTC users, 61% are taking medication for their ADHD alongside EndeavorOTC, and a quarter (25%) say they are trying EndeavorOTC because of difficulty obtaining their ADHD medication. Another reason people seek novel medical treatments like digital therapeutics or DTx is that even the gold-standard treatments for …Sales of EndeavorOTC were $341,000 from its launch on June 6, 2023, through Sept. 5, with revenue per user averaging $82. Meanwhile, Akili's 2023 second quarter revenues were $114,000. Catch up quick: Akili last August went public after merging with Chamath Palihapitiya's Social Capital Suvretta Holdings Corp. SPAC.EndeavorOTC is a digital therapeutic indicated to improve attention function, ADHD symptoms and quality of life in adults 18 years of age and older with primarily inattentive or combined-type ADHD. EndeavorOTC utilizes the same proprietary technology underlying EndeavorRx, a prescription digital therapeutic indicated to …Jan 22, 2024 · We built EndeavorOTC to help people improve their ADHD symptoms naturally. Based on our data, users report a reduction in their symptoms after around four to six weeks of using the treatment, but that doesn’t mean treatment isn’t working more quickly. To demonstrate EndeavorOTC’s impact, our data science, cognitive science, and clinical ... Akili today announced the official release of its new product, EndeavorOTC. The mobile game is a version of Akili’s similarly named, FDA-authorized EndeavorRX, built upon the same technology.EndeavorOTC is a new treatment option for adults with ADHD that can improve the brain’s mental processes related to inattention and ADHD symptoms in addition to, or without the need for, medication. However, much like going to the gym, this treatment requires commitment to regular usage and at least four to six weeks of initial treatment to ...Feb 7, 2024 · EndeavorOTC is a product built by parent company Akili – the same company that created EndeavorRx, the world’s first FDA–authorized prescription video game treatment for pediatric ADHD. As a digital therapeutic, EndeavorOTC was built by neuroscientists, cognitive scientists, clinical psychologists, and other healthcare professionals. Oct 31, 2023 · Endeavor OTC is the adult version of Endeavor RX, the first video game to receive FDA approval as a treatment for ADHD. The video game targets the parts of the brain involved in attention control ... EndeavorOTC is built on the same technology as Akili’s EndeavorRx ®, the world’s first and only FDA-authorized video game treatment, for children 8-12 years old with ADHD.In a recent clinical trial, EndeavorOTC significantly improved focus, attention, and overall quality of life in adults struggling with ADHD symptoms.The Focus Score measures how quickly and accurately you can complete a task despite distractions during EndeavorOTC treatment. The goal is to give you an easy way to track your focus improvement from your baseline Focus Score. At the start of treatment, we’ll provide you with a personalized target score.Jan 29, 2024 · EndeavorOTC is a digital therapeutic indicated to improve attention function, ADHD symptoms, and quality of life in adults 18 years of age and older with primarily inattentive or combined-type ADHD. Please see the Instructions for Use for additional indication and safety information. .