- Philips debuts EarlyVue VS30 vital signs monitor and receive 510(k) clearance in the U.S.- Early Warning Scoring, predictive trend analytics and intelligent algorithms help detect patient deterioration earlier to enable timely intervention.Royal Philips today announced the debut of EarlyVue VS30, a new vital signs monitor, in the U.S. Expanding on Philips’ General Care solutions portfolio, Philips EarlyVue VS30 uses automated Early Warning Scoring (EWS) to collect critical vital signs and
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FDA| Healthcare FDA Regulation | Policy, News, Analysis, Insights - HIT Consultant
Medtronic Launches FDA-Approved Deep Brain Stimulation Device in U.S.
- Samsung and Medtronic unveils new state of the art FDA-approved Deep Brain Stimulation (DBS) device that uses a surgically implanted medical stimulator to deliver electric pulses directly to the brain.- Rather than using a bulky medical device, the Medtronic DBS solution allows patients to manage their therapy more discreetly and actually can reduce the need for regular doctor visits through more streamlined coordination directly with clinicians.Medtronic announced the U.S. launch of its
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Cognoa Launches Pivotal Study of Diagnostic Aid for Autism
- Cognoa launches a pivotal study to demonstrate the effectiveness of its diagnostic aid for autism spectrum disorder (ASD).- The results of this pivotal study will be the basis for the submission to the FDA in 2020. - The Cognoa digital diagnostic aid has the potential to become the first cleared medical device to help diagnose autism intended to be used by pediatricians and primary care physicians.Cognoa, a Palo Alto, CA-based pediatric behavioral health company developing digital medicines,
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AppliedVR Awarded $2.9M Grants to Study Virtual Reality As An Opioid-Sparing Treatment
- AppliedVR awarded more than $2.9M in NIDA grants to support clinical trials to study virtual reality platforms as an opioid-sparing tool for acute and chronic pain. - The grants will enable the company to advance two clinical trial programs respectively with Geisinger and Cleveland Clinic.AppliedVR, a Los Angeles, CA-based next generation of digital medicine announced that it has been awarded two multi-year grants totaling more than $2.9 million from the National Institute on Drug Abuse
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Sleep Wearable Beddr Launches First Sleep Health Solution for Employers
- Beddr launches first holistic sleep wellness program for employers that leverages clinical-grade data from Beddr’s FDA cleared wearable.- Beddr expands upon its FDA-listed sleep wearable with improved data and insights, expert-led sleep coaching and sleep physician telemedicine network.Beddr, a pioneer in precision sleep health launched an industry-first comprehensive solution for employers focused on helping employees identify and treat the root causes of chronic sleep issues. The program
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Cleveland Clinic Names Top 10 Medical Innovations for 2020
- Cleveland Clinic panel of top doctors and researchers presents the 10 medical innovations with the power to transform healthcare in the next year.
Today at the 2019 Medical Innovation Summit, Cleveland Clinic today announced the Top 10 Medical Innovations for 2020. The 17th annual Medical Innovation Summit is organized by Cleveland Clinic Innovations, the development, and commercialization arm of Cleveland Clinic. Led by Michael Roizen, M.D., Emeritus Chief Wellness Officer at Cleveland
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Intelerad, Zebra Medical Vision Partner to Accelerate AI Adoption for Radiologists
- Intelerad and Zebra Medical Vision join forces to accelerate AI adoption through newly released Intelerad’s Odyssey workflow solution.- The partnership will further help radiologists increase productivity, improve clinical decisions and provide high-quality care globally.After expanding its “all-in-one” AI bundle, which includes 3 FDA 510(k) clearances, the deep learning medical imaging analytics company, Zebra Medical Vision, is now announcing a new joint partnership
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MaxQ AI Integrates With Philips CT System for Hospitals & Radiology Departments
- MaxQ AI’s ACCIPIO® ICH and stroke software will be integrated on Philips CT systems and will be available to hospitals and radiology departments throughout the U.S. and E.U.MaxQ AI, an Israeli-based medical diagnostic AI company announced that the company’s Accipio intracranial hemorrhage (ICH) and stroke software will be integrated on Philips’ computed tomography (CT) systems. MaxQ AI will be demonstrating the company’s full suite of Accipio solutions during the upcoming Radiological Society
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Fitbit, BMS-Pfizer Alliance Partner to Address Gaps in Atrial Fibrillation Detection
- Fitbit and the BMS-Pfizer Alliance are collaborating on a multi-year effort to accelerate the detection and diagnosis of atrial fibrillation (AFib) to reduce the risk of life-threatening events, like stroke.- The companies will use their combined resources and expertise to help identify and support people at increased risk for AFib, notably those 65+. The Bristol-Myers Squibb-Pfizer Alliance and Fitbit today announced a multi-year collaboration to help drive timely diagnosis of atrial
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McKesson, Aetion Partner on Real-World Evidence (RWE) in Cancer Research
- Aetion and McKesson announced a strategic collaboration focused on advancing the use of real-world evidence (RWE) in cancer research. - Relationship pairs Aetion Evidence Platform and McKesson’s robust oncology data sets to accelerate regulatory-grade oncology studiesAetion and McKesson, today announced a strategic collaboration focused on advancing the use of real-world evidence (RWE) in cancer research to benefit patients, regulators, the biopharma industry, and payers. The partnership will
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