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

FDA Extends RCA With COTA to Explore COVID’s Effect on Cancer

by Fred Pennic 11/04/2020 Leave a Comment

FDA Extends RCA With COTA to Explore COVID's Effect on Cancer

What You Should Know: - The FDA just extended its research collaboration agreement (RCA) with COTA, specifically looking at how COVID-19 is affecting cancer. - With this expanded agreement, COTA and the FDA will use real-world data to explore the impact of COVID-19 and the pandemic on cancer treatment, with the opportunity to expand into other oncology questions in the future. COTA, Inc., a healthcare technology company that uses real-world data to bring clarity to cancer care,
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Fern Health Taps 10M Mass General De-Identified Patient Records for Pain Management

by Fred Pennic 10/30/2020 Leave a Comment

What You Should Know: - Fern Health will reveal a first-of-its-kind collaboration with Mass General Hospital where it will inform existing and future digitally-delivered pain management programs through the marriage of AI + predictive analytics with 10 million de-identified Mass General patient records. - MGH will validate emerging Fern Health products and pilot new products in clinical environments, setting the stage for Fern expansion into all aspects of non-invasive multimodal pain
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Northwestern to Deploy FDA-Cleared Deploy AI-Guided Cardiac Ultrasounds

by Fred Pennic 10/28/2020 Leave a Comment

What You Should Know: - Northwestern Memorial Hospital is the first in the nation to deploy FDA-cleared AI-guided ultrasound by Caption Health, including measurement of ejection fraction – the most widely used measurement to assess cardiac function. - Caption Health's AI-guided cardiac ultrasound enables clinicians – including those without experience – to accurately perform diagnostic-quality exams -- accelerating the availability of information and saving lives. - Caption AI has been
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FDA Clears First-in-World Hematology App, Unlocking Potential of Diagnosis

by Jasmine Pennic 10/23/2020 Leave a Comment

FDA Clears First-in-World Hematology App, Unlocking Potential of Diagnosis

What You Should Know: - Scopio Labs announced FDA clearance of its AI-powered X100 microscope and decision support system with Full Field Peripheral Blood Smear (Full Field PBS) application.  - Using advanced computational photography imaging and tailored AI tools, Full Field PBS gives clinical laboratories an unprecedented ability to capture digital scans with full-field view of the monolayer and feathered edge at 100X oil immersion resolution level.  - The global market for
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FDA Grants AppliedVR Breakthrough Designation for Virtual Reality Chronic Pain Treatment

by Jasmine Pennic 10/21/2020 Leave a Comment

FDA Grants AppliedVR Breakthrough Designation for Virtual Reality Chronic Pain Treatment

What You Should Know: - FDA awards AppliedVR Breakthrough Device designation for treating treatment-resistant fibromyalgia and chronic intractable lower back pain - AppliedVR’s EaseVRx program helps patients learn self-management skills grounded in evidence-based cognitive-behavioral therapy (CBT) principles and other behavioral methods. AppliedVR, a pioneer advancing the next generation of digital medicine, today announced its EaseVRx product received Breakthrough Device designation
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3M and Eko Launches 3M Littmann® CORE Digital Stethoscope for Clinicians

by Fred Pennic 10/19/2020 Leave a Comment

3M and Eko Launches 3M Littmann® CORE Digital Stethoscope for Clinicians

What You Should Know: - 3M and Eko team up to launch 3M Littmann® CORE Digital Stethoscope to deliver a game-changing tool for clinicians as they assess, diagnose, and monitor their patients. - The new 3M Littmann CORE Digital Stethoscope offers clinicians access to both analog and digital auscultation options and connects to Eko’s software and AI algorithms* to help clinicians better interpret sounds and detect heart murmurs. 3M™ Littmann® Stethoscopes and Eko, today announced the
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Fujifilm & Volpara Partner to Help Clinicians Determine Patient Breast Density

by Jasmine Pennic 10/15/2020 Leave a Comment

Fujifilm & Volpara Partner to Help Clinicians Determine Patient Breast Density

What You Should Know: - FUJIFILM Medical Systems U.S.A., Inc. and Volpara Solutions announced the extension of their partnership to provide mammography facilities and clinicians with breast imaging solutions designed to improve image quality, streamline workflow and accurately assess a patient's breast density. - Building on a successful 6-year partnership, Fujifilm's customers using ASPIRE Cristalle with Digital Breast Tomosynthesis (DBT) now have access to the latest innovations from
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Corrona Acquires Virtual Patient Community HealthUnlocked

by Fred Pennic 10/14/2020 Leave a Comment

Corrona Acquires Virtual Patient Community HealthUnlocked

What You Should Know: - Nationwide disease registry Corrona has acquired virtual patient community HealthUnlocked, creating a first-in-class patient experience ecosystem. - The acquisition will enable Corrona to expand its broad set of capabilities--ranging from highly granular and longitudinal structured data across eight registries. Corrona, LLC  ("Corrona"), a nationwide disease registry and is now the largest registry in the world collecting data on Rheumatoid Arthritis
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Tyto Care Launches AI-Powered Diagnostic Support Solution

by Fred Pennic 10/13/2020 Leave a Comment

Amwell, Tyto Care Expand Partnership to Power Augmented Virtual Care Experiences

What You Should Know: - Today, Tyto Care announced the company’s evolution from telehealth to tele-diagnosis with its AI-powered diagnostic support solution, providing clinicians with advanced insights for informed remote diagnoses.  - The solution will improve the quality of remote triage for common primary and chronic health issues – starting with wheezing and stridor – grounded in Tyto Care’s industry-leading repository of remote exam videos, sounds and images. Tyto Care, a
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Virta Adds Prediabetes and Obesity Reversal to Services

by Jasmine Pennic 10/07/2020 Leave a Comment

Virta Expands Offerings to Treat New Group of Chronic Illnesses

What You Should Know: - Virta is expanding its suite of treatment options to include prediabetes reversal, obesity reversal, and type 2 diabetes management. - By making this crucial expansion, Virta can scale its treatment to support the tens of millions of additional patients with prediabetes and obesity, as provide an on-ramp to reversal for those with T2D that aren’t yet ready to reverse.  Virta Health, the leader in type 2 diabetes reversal, today introduced the addition
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