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

Biden-⁠Harris Admin Awards $1.5B to Address Overdose Epidemic

by Jasmine Pennic 09/26/2022 Leave a Comment

Biden-⁠Harris Admin Awards $1.5B to Address Overdose Epidemic

What You Should Know: - The U.S Department of Health and Human Services (HHS), through the Substance Abuse and Mental Health Services Administration (SAMHSA), awarded nearly $1.5 billion to support states, tribal lands, and territories’ efforts to address the opioid crisis and support individuals in recovery. - The grants are part of SAMHSA’s State Opioid Response and Tribal Opioid Response grant programs. The grant programs provide funding to states and territories to increase access to
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Assisted Polyp Detection Device Receives FDA Clearance

by Syed Hamza Sohail 09/22/2022 Leave a Comment

AI-Assisted Polyp Detection Device Receives FDA Clearance

What You Should Know: - Iterative Scopes, a pioneer in precision medicine technologies for gastroenterology, and Provation, the premier software and SaaS provider of clinical productivity and workflow automation solutions, announced recently that SKOUT™ has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for adults undergoing colorectal cancer screening or surveillance. - The device was evaluated in the largest U.S.-based multicenter clinical study for a
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Virtual Reality Therapy May Serve as Effective Adjunct To Anesthesia For Surgical Procedures

by Syed Hamza Sohail 09/21/2022 Leave a Comment

XRHealth Launches Virtual Reality Telehealth Clinic in Israel

What You Should Know: - The results of a clinical trial using software from XRHealth, developer and operator of virtual treatment rooms in the metaverse,  published in PLOS ONE demonstrated that virtual reality therapy may serve as an effective adjunct to anesthesia for surgical procedures. The trials were conducted with XRHealth’s immersive virtual reality software. - The results of the trial showed that the majority of patients (13/17) using the XRHealth VR technology did not need
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Eko Lands $2.7M NIH Grant to Train Pulmonary Hypertension AI

by Syed Hamza Sohail 09/20/2022 Leave a Comment

Eko Lands $2.2M NIH Grant to Train Pulmonary Hypertension AI

What You Should Know: - Eko, a digital health company applying machine learning in the fight against heart and lung disease, today announced that it was awarded a $2.7M Small Business Innovation Research (SBIR) Direct Phase II grant by the National Institutes of Health’s (NIH) Department of Health and Human Services (HHS). - The grant will fund the development of a machine learning algorithm that detects and stratifies pulmonary hypertension (PH) using phonocardiogram (PCG) and
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RWJUH Opens Center for Innovation for Medical Research

by Jasmine Pennic 09/16/2022 Leave a Comment

RWJUH Opens Center for Innovation for Medical Research

What You Should Know: - Robert Wood Johnson University Hospital (RWJUH), an RWJBarnabas Health facility, and Rutgers Robert Wood Johnson Medical School (RWJMS) launched a new model for medical research and innovation today at the grand opening of its Center for Innovation, located on the main campus of the hospital. - The Center for Innovation is a partnership between RWJUH and Rutgers RWJMS to bring together clinicians, researchers and private industry to invent and develop new
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Ypsomed & Sidekick Health Partner to Improve Therapy Outcomes

by Syed Hamza Sohail 09/08/2022 Leave a Comment

Ypsomed & Sidekick Health Partner to Improve Therapy Outcomes

What You Should Know: - Ypsomed and Sidekick Health today announced a collaboration to extend Ypsomed’s device and SmartServices offering by implementing a self-injection module in Sidekick’s proven digital therapeutics solution. - The combination of Ypsomed’s devices with Sidekick’s digital health, behavioural economics and gamification expertise will form a unique solution delivering an engaging and personalized patient experience to people with chronic conditions, as well as a turn-key,
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Femtech – Changing Dynamics of Women’s Healthcare

by Aditi Basu, Marketing Head at Future Market Insights 09/02/2022 Leave a Comment

Femtech – Changing Dynamics of Women’s Healthcare

Femtech a term coined by Danish entrepreneur Ida Tin in 2016 has become a revolutionary moment for women across the globe. Femtech as the term suggests focuses on using technology to solve health issues in females. Although women are the primary caregivers of families, they themselves are at the receiving end of not getting treated for the ailments they suffer. This is owing to multiple reasons that range from socio-economic conditions, lack of awareness regarding health issues and less or no
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Viz.ai Receives Clearance for New Algorithm for Pulmonary Embolism

by Fred Pennic 09/01/2022 Leave a Comment

Viz.ai Receives Clearance for New Algorithm for Pulmonary Embolism

What You Should Know: - Viz.ai, a provider of AI-powered disease detection and intelligent care coordination, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for an automated RV/LV ratio algorithm, a seamless new component of the Viz PE Solution (launched in November 2021). - The algorithm is designed to quickly and accurately measure the diameter of the heart's ventricles to provide the ratio of the maximum right ventricle (RV) diameter versus that
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Medical Devices Cleared or Approved by FDA in 2022

by Fred Pennic 08/29/2022 Leave a Comment

Food and Drug Administration - FDA title=Food and Drug Administration - FDA _Medical Devices Cleared or Approved by FDA in 2022

The medical device industry is booming and shows no signs of slowing down. In 2022, the FDA (Federal Food and Drug Administration) will clear or approve over 1,000 medical devices. This is great news for patients who stand to benefit from the latest and greatest technology, but it can be tough for hospitals and doctors to keep up with all of the new devices on the market.  Here's a breakdown of some of the most anticipated otc medical devices that have already received FDA approval. Some
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Glytec and CPS Integrate to Provide Evidence-Based Glycemic Management

by Syed Hamza Sohail 08/24/2022 Leave a Comment

Glytec and CPS Integrate to Provide Evidence-Based Glycemic Management

What You Should Know: - Glytec recently announced that it has been selected by CPS Solutions, LLC (CPS), a leading provider of enterprise pharmacy solutions to hospitals and health systems, to serve as an insulin management technology resource for CPS’ more than 2,200 pharmacy professionals across 800-plus healthcare facilities nationwide. - Through this collaboration, CPS client facilities may contract for Glytec’s eGlycemic Management System® (eGMS) and Glytec’s technical resources to be
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