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FDA Clearance

FDA Clears AI-Powered EchoGo Core for Early Detection of Cardiovascular Disease

by Fred Pennic 11/15/2019 Leave a Comment

FDA Clears AI-Powered EchoGo Core for Early Detection of Cardiovascular Disease

- Ultromics has just become one of the first companies to have 510(k) FDA clearance for an AI medical device. - EchoGo will now be available for clinicians in the UK and US to use to help them identify cardiovascular disease earlier. - EchoGo automates cardiac measurements and is the first AI application to measure cardiac strain, improving patient care and outcomes.Ultromics, the UK-based health technology firm at the forefront of applying artificial intelligence to echocardiography has
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FDA Clears GE Healthcare’s AI Algorithms Embedded on Mobile X-Ray Device

by Fred Pennic 09/13/2019 Leave a Comment

GE Healthcare Receives FDA Clearance of First Artificial Intelligence Algorithms Embedded On-Device to Prioritize Critical Chest X-ray Review

- GE Healthcare awarded Food and Drug Administration’s 510(k) clearance of Critical Care Suite, an industry-first collection of artificial intelligence (AI) algorithms embedded on a mobile X-ray device. - Algorithms help radiologists prioritize critical cases with a suspected pneumothorax – a type of collapsed lung – by immediately flagging critical cases to radiologists for triage, which could drastically cut the average review time from up to eight hours. - Critical Care Suite offers
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Healthy.io Nabs $60M for FDA-cleared Smartphone-Based Urinalysis for Chronic Kidney Disease

by Jasmine Pennic 09/12/2019 Leave a Comment

Healthy.io Nabs $60M for FDA-cleared Smartphone-Based Urinalysis for Chronic Kidney Disease

- Healthy.io raises $60M led by Corner Ventures for its FDA 510(k) cleared smartphone-based ACR test to be used in the aid of diagnosing chronic kidney disease (CKD). - The funding round will be used to accelerate Healthy.io’s global expansion and product development. - Healthy.io’s solution allows immediate electronic medical record (EMR) connectivity through the automated smartphone scan.  Healthy.io, the fast-growing Israeli digital health company that has turned the
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What’s AI’s Holdup in Healthcare? The Answer Is In The Cloud

by Fabien Beckers, Ph.D., CEO, Arterys 08/13/2019 Leave a Comment

What’s AI’s Holdup in Healthcare? The Answer Is In The Cloud

When you consider what technology has the most potential to transform healthcare over the next decade and beyond, no doubt your first thoughts turn to artificial intelligence (AI), machine learning (ML) and deep learning (DL). Already these technologies are showing promise in helping clinicians work faster and smarter, identifying trends, alerting us to signs that can predict and prevent diseases, and providing insights into potential treatments and cures.  But AI, ML, and DL alone cannot
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What’s the Difference: A Look at Consumer and Medical-Grade Wearables in Healthcare

by Erica Garvin 07/08/2019 Leave a Comment

What’s the Difference: A Look at Consumer and Medical-Grade Wearables in Healthcare

Can both consumer and medical-grade wearables work together to fill healthcare’s care gaps? Dr. Sunil Kapur shares his insights. What does Abbott’s Confirm Rx insertable cardiac monitor (ICM) and the latest Apple Watch have in common? The answer: more than you think, and perhaps not nearly enough. Today, consumer and medical-grade wearables may live in different markets, but they are aligning on a similar long-term objective—capturing critical data to improve outcomes. “People want to
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MaxQ AI Launches FDA Cleared, CE Approved Slice-Level Intracranial Hemorrhage Detection

by Fred Pennic 05/21/2019 Leave a Comment

MaxQ AI Launches FDA Cleared, CE Approved Slice-Level Intracranial Hemorrhage Detection

 MaxQ AI, an Israeli-based medical diagnostic AI company has launched the company’s new ACCIPIO Ax solution, which features SliceMap, an integrated view that guides clinicians rapidly to CT slices with suspected intracranial hemorrhage (ICH) without leaving their PACS viewer. Slice-Level Intracranial Hemorrhage DetectionACCIPIO Ax is FDA Cleared, CE Approved, and the second component of MaxQ AI’s ACCIPIO ICH Platform, the complete ICH solution for stroke and head trauma assessment. Radiology
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Neural Analytics Lands $22M for Robotically Assisted Ultrasound System for Brain Health Assessment

by Fred Pennic 05/10/2019 Leave a Comment

Neural Analytics, Inc., a Los Angeles, CA-based medical robotics company developing and commercializing technologies to measure and track brain health has raised $22 million in Series C funding led by Alpha Edison and the Company has also issued warrants to purchase stock in connection to the financing. The investment brings Neural Analytics’ total funding to approximately $66 million.Impact of Neurological DiseasesNeurological diseases such as stroke affects more than 795,000 people each year
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RefleXion Medical Receives $60M Loan for Biology Guiding Radiotherapy Machine

by Jasmine Pennic 05/02/2019 Leave a Comment

RefleXion Medical, Inc., a biotargeting oncology company developing the first and only biology-guided radiotherapy (BgRT) machine* for targeted cancer treatment has received a $60M senior secured term loan from Oxford Finance LLC. The company plans to use the loan to support the completion of the FDA clearance process for its biology-guided BgRT system and its subsequent commercial launch. Building from Positron Emission Tomography Positron emission tomography (PET) is an established
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Medical Informatics Corp. Raises $11.9M for FDA-Cleared Patient Monitoring and Predictive Analytics Platform

by Fred Pennic 04/03/2019 Leave a Comment

Medical Informatics Corp. Raises $11.9M for FDA-Cleared Patient Monitoring and Predictive Analytics Platform

Medical Informatics Corp. (MIC), a Houston, TX-based provider of an FDA-cleared patient monitoring and predictive analytics platform has raised $11.9M in Series A funding led by Data Collective Venture Capital (DCVC) with significant participation from Intel Capital and the Texas Medical Center (TMC) Venture Fund.The Inaccurate State of Today’s Predictive Analytics in Hospital SystemsHospital systems across the country are searching for ways to use machine learning and AI to get ahead of
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UM Spinout Fifth Eye Lands $11.5M for Early Warning Patient Deterioration System for Hospitals

by Fred Pennic 04/01/2019 Leave a Comment

UM Spinout Fifth Eye Lands $11.5M for Early Warning Patient Deterioration

Fifth Eye, a medical device software spinoff from the University of Michigan building clinical early warning patient deterioration system for hospitals has raised $11.5 million in Series A funding led by Arboretum Ventures and Cultivation Capital. Other participants in the round include were MINTS, the direct investing arm of the University of Michigan’s endowment, along with additional capital from previous investors Invest Michigan and 35 private angel investors.Why Clinicians Need A Better
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