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FDA| Healthcare FDA Regulation | Policy, News, Analysis, Insights - HIT Consultant

Inspire Medical Systems Invests in AI Startup EnsoData

by Fred Pennic 04/29/2022 Leave a Comment

Inspire Medical Systems Invests in AI Startup EnsoData

What You Should Know: - Inspire Medical Systems has announced its investment in EnsoData, an artificial intelligence (AI) healthcare company helping clinicians uncover disease while patients sleep.  - EnsoData’s technology helps address some of the most intractable problems in healthcare: access and affordability for patients and clinician burnout. By letting doctors and other clinicians use powerful AI to automatically analyze and diagnose diseases while a patient sleeps, EnsoData
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Komodo Health & AppliedVR Partner to Drive Therapeutic VR for Chronic Pain

by Jasmine Pennic 04/28/2022 Leave a Comment

AppliedVR Secures $36M to Scale Therapeutic Virtual Reality Platform for Pain Management

What You Should Know: - Komodo Health, a company delivering patient-level insights by dynamically analyzing the broadest array of data across patients, practitioners, and health systems. today announced a new partnership with AppliedVR, the leader in therapeutic virtual reality (VR) for pain management. - Using Komodo’s technology, AppliedVR will combine its proprietary insights with Komodo’s real-world data to conduct clinical research into the efficacy, cost savings, and health system
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Reify Health Secures $220M to Support Clinical Trial Diversity at $4.8B Valuation

by Fred Pennic 04/21/2022 Leave a Comment

Reify Health Secures $220M to Support Clinical Trial Diversity

What You Should Know: - Reify Health, a leading provider of solutions that empower the clinical trial ecosystem, announced a $220M Series D funding round dedicated to improving diversity in clinical research. The investment comes less than a year after its Series C and brings the company's valuation to $4.8B.  - The Series C found was co-led by Altimeter Capital and Coatue, joined by Dragoneer Investment Group and existing investors ICONIQ Growth, Adams Street, and Battery
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Blue Spark Technologies Raises $40M for AI-Based Remote Patient Monitoring

by Jasmine Pennic 04/18/2022 Leave a Comment

Blue Spark Technologies Raises $40M for AI-Based Remote Patient Monitoring

What You Should Know: - Blue Spark Technologies, Inc., a Cleveland, OH-based provider of wearable remote patient monitoring solutions, announced that it has raised $40 million in growth funding led by Ghost Tree Partners with support from Aon. - The funding will go towards scaling the company’s sales and marketing functions and the continued advancement of Blue Spark’s wearable remote patient monitoring solutions. Continuous, Real-Time Body Temperature Monitoring System TempTraq®,
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Vivalink Expands Use of its Biometrics Data Platform

by Jasmine Pennic 04/12/2022 Leave a Comment

Vivalink Launches RWE Biometrics Data Platform

What You Should Know: - Vivalink, a leading provider of digital healthcare solutions, has expanded its Biometrics Data Platform - which delivers uninterrupted streams of real-world physiological data - to enable faster algorithm development for disease detection and diagnosis.  - More than 100 digital healthcare application companies and customers in 32 countries are already developing a wide range of medical applications for remote patient monitoring and clinical trials based on the
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Fitbit Receives FDA Clearance for New PPG Algorithm to Identify AFib

by Fred Pennic 04/12/2022 Leave a Comment

Fitbit Receives FDA Clearance for New PPG Algorithm to Identify AFib

What You Should Know: - Fitbit announced it has received clearance from the FDA for its PPG (photoplethysmography) algorithm to identify atrial fibrillation (AFib), a condition that affects more than 33.5 million people globally.  - The algorithm will soon be available to users in the U.S. through Fitbit’s new Irregular Heart Rhythm Notifications feature on eligible heart-rate tracking devices.
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Arterys Receives FDA Clearance for Next-Gen Cardiac MRI App

by Jasmine Pennic 04/08/2022 Leave a Comment

Arterys Receives FDA Clearance for Next-Gen Cardiac MRI App

What You Should Know: - Arterys, the world's leading vendor-neutral artificial intelligence (AI) platform, has announced several new modules to its already robust Cardio AI clinical application and an additional FDA AI clearance based on deep learning.  - Cardio AI is a comprehensive, cloud-based post-processing solution that leverages AI and deep learning to provide extremely accurate, automated, fast, repeatable analysis of cardiac MRI images. Cardio AI: AI-Assisted Cardiac MRI
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At-Home Testing Is The Future, But Lab APIs Are Stuck In The Past

by David Stein, CEO of Ash Wellness 04/07/2022 Leave a Comment

At-Home Testing is the Future, but Lab APIs are Stuck in the Past

The rise of telemedicine and virtual care options have primed at-home testing to make a significant impact on the future of healthcare. 70% of today’s medical decisions depend on laboratory test results, but lagging lab APIs hinder the widespread launch of remote diagnostics.  Since the start of the COVID-19 pandemic, there has been a major increase in telemedicine usage, including a 154% increase in telehealth visits during the last week of March 2020 alone. Both patients and doctors
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MemorialCare Taps TytoCare to Offer Virtual Exam Kits for Enhanced Telehealth

by Fred Pennic 04/04/2022 Leave a Comment

COVID-19 Spikes Deaconess Health Adoption of Remote Medical Exams

What You Should Know: - TytoCare, a provider of AI-powered, on-demand, remote medical exams has inked a partnership with MemorialCare, a health system in Orange and Los Angeles Counties, to bring patients diverse telehealth options and allow them to pursue comprehensive primary care options from home. - The integration of the TytoCare solution into MemorialCare’s current telehealth appointments enhances the health system’s ability
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ConcertAI Raises $150M at $1.9 Billion Valuation for RWD Platform

by Fred Pennic 03/29/2022 Leave a Comment

ConcertAI Raises $150M at $1.9 Billion Valuation for RWD Platform

What You Should Know: - ConcertAI, LLC (ConcertAI), the leader in enterprise AI and real-world data (RWD) solutions for life sciences and healthcare, announced the close of its $150M in Series C led by Sixth Street at a $1.9B valuation. - From its startup just five years ago, ConcertAI has emerged as one of the fastest-growing companies providing high-value software-as-a-service (SaaS) and data solutions to life sciences and biopharma companies, leading healthcare providers, contract
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