I'm delighted to share that last week NotYet accomplished a significant milestone for any MedTech startup in the US: We’ve started the FDA clearance process. We filed a submission under the PreSTAR program. This is a great opportunity that was recently developed by the FDA to streamline the clearance process for new innovative products. The PreSTAR program provides significant time and cost savings, as well as an early verification of FDA requirements. The NotYet team has worked extremely hard to drill down into the details of compliance and clinical trial plans. I really appreciate the support of our partners who have contributed greatly: TechnoSTAT Clinical Services, Tal Zucker, Yulia Gavrilov, Naida Gurshumov Alexander, PhD, IMD Medical Device Academy, Inc., Rob Packard MECA We're looking forward to meeting with the FDA in July 🤞
עלינו
Our primary goal is to extend and improve the elderly’s lives by giving physicians real-time data to react in advance We do this through three elements: - Our own device continuously and accurately measures blood pressure and all the necessary indicators, chosen specifically for the elderly. This provides a physician with a comprehensive clinical picture for preventive care - An application, fully adapted for senior users and taking into account problems with vision and fine motor skills. It helps to engage the elderly in managing of their health - A platform that constantly monitors patients and automatically calculates deviations using all necessary medical guidelines and AI. This allows the physician to react quickly even with a large number of patients. And why are we better? 1. A unique method for measuring blood pressure that is best suited for the elderly, even with problematic blood vessels. 2. Our wristband collects the widest range of indicators on the market without breaking lifestyle. So healthcare providers get ultimate rich data to monitor and predict the most frequent CVD risks among the elderly. 3. Our solution provides real-time feedback. Our solution can be applied for remote patient monitoring with 100% insurance reimbursement (for Medicare and Medicaid).
- אתר אינטרנט
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https://notyet.tech/
קישור חיצוני עבור NotYet Inc
- תעשייה
- Health and Human Services
- גודל החברה
- 2-10 עובדים
- משרדים ראשיים
- Tel Aviv
- סוג
- חברה ציבורית
- הקמה
- 2023
מיקומים
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הראשי
קבלת הוראות הגעה
Tel Aviv, IL
עובדים ב- NotYet Inc
עדכונים
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I'm excited to share a fantastic experience the NotYet Inc team is having at the Caelestinus HealthTech Incubator. Thanks to the invaluable support of InterSystems, a world leader in medical data processing and interoperability, we can swiftly set up a pilot project. In our first month of participation, we have already gained very useful and applied insights into regulation, solution architecture, and distribution. Our heartfelt thanks to the Incubator experts for their assistance and guidance: Tomas Studenik, Evgeny Shvarov, Petr Žabka, Ales Martinovsky, and Irina Baskova I expect NotYet to make even more impressive progress over the next 2 months through participation in the Caelestinus.
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