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FDA Clearance

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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Clarius Unveils Ultra-High Frequency Handheld Ultrasound Scanner

by Fred Pennic 09/23/2020 Leave a Comment

Clarius Unveils Ultra-High Frequency Handheld Ultrasound Scanner

What You Should Know:   - A pioneer in high definition ultrasound miniaturization, Clarius is announcing the new high-frequency handheld ultrasound scanner Clarius L20 HD featuring the highest definition wireless imaging for superficial applications. - Designed to provide extremely high image quality in the near field (skin line to 4cm), the Clarius L20 HD is ideal for a variety of clinical settings including MSK, rheumatology, podiatry, plastic surgery, microsurgery, pediatric
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RADLogics Secures FDA Clearance for AI-Powered Chest X-Ray App for Triage & Prioritization

by Jasmine Pennic 09/22/2020 Leave a Comment

RADLogics Secures FDA Clearance for AI-Powered Chest X-Ray App for Triage & Prioritization

What You Should Know: - RADLogics today announced that it has secured 510(k) clearance from the FDA for the company’s novel AI-Powered chest X-ray pneumothorax application, which identifies and prioritizes chest X-ray scans that appear to contain a pneumothorax, a collapsed lung, for urgent radiologist review. - RADLogics’ FDA cleared CT and X-ray solutions – including this application – are
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Fitbit Awarded Regulatory Clearance in U.S. and Europe for ECG App to Identify AFib

by Fred Pennic 09/14/2020 Leave a Comment

Fitbit Awarded Regulatory Clearance in U.S. and Europe for ECG App to Identify AFib

What You Should Know: - Fitbit has received 510(k) clearance from the FDA, as well as CE marking in the European Union, for its ECG app to assess heart rhythm for atrial fibrillation. The Fitbit ECG App is a simple way people can take an on-the-spot reading of their heart rhythm at any time, including whenever they notice any unusual cardiac symptoms.  - Fitbit Sense is the company’s first device compatible with an ECG app that enables users to take a spot
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Caption Health AI Awarded FDA Clearance for Point-of-Care Ejection Fraction Evaluation

by Jasmine Pennic 07/23/2020 Leave a Comment

FDA Expedites Clearance for AI Ultrasound Solution to Fight COVID-19

What You Should Know: - Caption Health AI is awarded FDA 510(k) clearance for its innovative point-of-care ejection fraction evaluation. - Latest AI ultrasound tool makes it even easier to automatically assess ejection fraction, a key indicator of cardiac function, at the bedside--including on the front lines of the COVID-19 pandemic. Caption Health, a Brisbane, CA-based leader in medical AI technology, today announced it has received FDA 510(k) clearance for an updated version of
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Eko Awarded $2.7M NIH Grant for Heart Murmur & Valvular Heart Disease Detection Algorithms

by Fred Pennic 07/22/2020 Leave a Comment

FDA Breakthrough Status Granted for Heart Failure Algorithm by Eko

What You Should Know: - The National Institutes of Health (NIH) has granted next-generation cardiac AI company Eko an award totaling $2.7 million to support continued collaborative work with Northwestern Medicine Bluhm Cardiovascular Institute - The grant will focus on validating algorithms and help more accurately screen for heart murmurs and valvular heart disease during routine office visits with Northwestern Medicine. - By incorporating data from tens of thousands of
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Activ Surgical Raises $15M Advance Autonomous and Collaborative Surgery

by Fred Pennic 07/16/2020 Leave a Comment

Activ Surgical Raises $15M Advance Autonomous and Collaborative Surgery

What You Should Know: - Digital surgery pioneer Activ Surgical raises $15M in funding led by ARTIS Ventures to accelerate U.S. commercialization and European expansion efforts for its ActiveEdge platform, which enables existing surgical systems, from scopes to robots, to visualize, characterize and track tissue, in real-time beyond today’s human capability.  - ActivSight, is an easy-to-adapt, connected imaging module that seamlessly attaches to today’s laparoscopic and arthroscopic
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Caption Health Nabs $53M to Commercialize FDA-Cleared AI-Guided Ultrasound Technology

by Fred Pennic 07/15/2020 Leave a Comment

GE HealthCare to Acquire Caption Health

What You Should Know: - Caption Health raises $53 million series B round to fuel commercialization and expansion of its FDA-approved AI ultrasound technology. This is on the heels of its receiving FDA clearance, designated as a breakthrough technology to fight against COVID-19. - As ultrasounds, especially cardiac ultrasounds, have become increasingly important during a time of COVID when resources are stretched, using AI to help more healthcare professionals take high-quality images is
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18 Healthcare Augmented Reality and Virtual Reality Companies to Watch

by HITC Staff 06/29/2020 Leave a Comment

Fundamental Surgery Becomes First VR Surgical Training Simulation to Gain CPD Accreditation

Augmented reality (AR) and virtual reality (VR) are redefining what's possible in healthcare, as well as other sectors. The 18 companies listed below are some of the top virtual and augmented reality companies in the medical industry.  Defining Augmented Reality Augmented reality is a technology that blends real-world elements with virtual ones. For example, a person might visit a trade show and aim their smartphone at a display to activate an AR experience that allows them to see
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Welldoc Awarded 8th FDA Clearance for Bluestar Medical Device for Diabetes

by Jasmine Pennic 06/04/2020 Leave a Comment

Welldoc’s BlueStar Integration with Xealth Improves Patient Engagement by 2.5X

What You Should Know: Marks 8th FDA clearance for BlueStar, the only reimbursable software as a medical device for diabetes that integrates with all of a patient's existing devices. Welldoc, revolutionizing digital health with the first FDA-cleared Software as a Medical Device (SaMD) for diabetes, announced today that the U.S. Food and Drug Administration (FDA) has cleared an additional feature for the digital health product BlueStar Rx which supports individuals using long-acting
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