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

Oncoustics Raises $5M for AI-Driven Point-of-Care Diagnostics

by Syed Hamza Sohail 07/22/2022 Leave a Comment

Oncoustics Raises $5M for AI-Driven Point-of-Care Diagnostics

What You Should Know: - Oncoustics, San Francisco, CA-based ultrasound-based tissue characterization solutions announces the initial close of a $5 million+ seed round of funding to advance its SaMD (software as a medical device) technology for the low-cost assessment of structural diseases at the point of care. - Oncoustics’ first products will focus on liver disease, one of the fastest-growing causes of morbidity and mortality in the world. The round is co-led by Creative Ventures
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RapidAI Awarded FDA Clearance for AI-Powered CT Scans to Identify Intracerebral Hemorrhage

by Syed Hamza Sohail 07/21/2022 Leave a Comment

RapidAI Awarded FDA Clearance for AI Powered CT Scans to Identify Intracerebral Hemorrhage

What You Should Know: - RapidAI, the global leader in neurovascular and vascular AI-enhanced clinical decision support and patient workflow, today announced it has received FDA clearance for Rapid Hyperdensity, the newest addition to the RapidAI platform. - The tool empowers physicians to quickly assess the severity of injury in patients with acute neuro conditions such as traumatic brain injury and brain hemorrhages – allowing for better and faster patient care decisions. AI Powered
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Caption Health Receives CE Mark for AI Ultrasound Tech

by Syed Hamza Sohail 07/19/2022 Leave a Comment

Caption Health AI Awarded FDA Clearance for Point-of-Care Ejection Fraction Evaluation

What You Should Know: - Caption Health, the leader in using artificial intelligence (AI) and services to improve heart ultrasound access, today announced that it has received a CE Mark for its Caption AI™ technology platform. - This certification represents the first step in making Caption Health’s industry-leading technology platform available outside the US, and highlights the company’s strong clinical and regulatory track record as it uses AI and ultrasound to deliver better cardiac
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Wysa Secures $20M for AI-Powered Mental Health Chatbot

by Jasmine Pennic 07/14/2022 Leave a Comment

Wysa Secures $20M for AI-Powered Mental Health Chatbot

What You Should Know:  - Wysa, a Boston, MA-based AI digital platform for mental health, today announces it has secured $20M in financing led by HealthQuad, who along with British International Investment (BII), the UK’s development finance institution, joins earlier investors W Health Ventures, Kae Capital, Google Assistant Investments, and pi Ventures amongst others. - Funds will enable access to clinically evidenced digital therapeutics (DTx) in the US, UK, India and other global
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FDA Clears Eko’s Heart Disease Detection AI for Adults and Pediatrics

by Fred Pennic 07/12/2022 Leave a Comment

FDA Clears Eko’s Heart Disease Detection AI for Adults and Pediatrics

What You Should Know: - Today, Eko, a digital health company advancing heart and lung disease detection, has announced the FDA has issued clearance for its Eko Murmur Analysis Software (EMAS), the first and only machine learning algorithm to screen for valvular heart disease (VHD). - The next generation of Eko’s murmur detection capabilities grants Eko the first and only smart stethoscope on the market that can identify and
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Path to Predictive Patient Data: Silencing The Noise of Healthcare

by Shane Cooke, CEO and President of Etiometry 07/06/2022 Leave a Comment

Consolidated Patient Data: Silencing the Noise of Healthcare

As the healthcare industry is experiencing major changes in the wake of the pandemic, how do we cut through the noise of beeping monitors and the constant influx of data each patient produces in a given moment to ensure optimal care, especially for critically ill patients? Instead of adding a new beep or silencing the existing ones, why not build a path through the noise with data? The Path to Predictive Data  Nearly every advancement in healthcare has been centered around data, with
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Analysis: How Will The Roadmap for Diagnostic Cardiology Devices Develop?

by Kelly Patrick, Principal Analyst at Signify Research 06/30/2022 Leave a Comment

Analysis: How Will The Roadmap for Diagnostic Cardiology Devices Develop?

Like most healthcare markets, the diagnostic cardiology market has had a bumpy ride in recent years. The COVID-19 pandemic saw global revenues for Resting ECG devices increase in 2020, whilst ECG Management Systems, Stress ECG and Traditional Holter ECG solutions saw a market decline. Country lockdowns resulted in reduced cardiology services during the peak of the pandemic, as non-urgent appointments were delayed. 2021 showed relief for cardiac facilities as providers started to deal with the
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ITC Judge Finds Apple Infringed AliveCor Patents

by Fred Pennic 06/28/2022 Leave a Comment

AliveCor Launches KardiaMobile Card, World’s First Credit-Card-Sized Personal ECG

What You Should Know: - Today, an International Trade Commission (ITC) judge issued an Initial Determination that Apple infringed AliveCor’s valid patented technology – a finding that may result in a limited exclusion order that will prohibit the import of infringing Apple Watches into the United States. - AliveCor initially filed its complaint with the ITC in April 2021, alleging that Apple infringed AliveCor’s
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AWS & MATTER Launches Incubator for EMEA Healthcare Startups Entering US Market

by Fred Pennic 06/23/2022 Leave a Comment

AWS & MATTER Launches Incubator for EMEA Healthcare Startups Entering US Market

- Amazon Web Services (AWS) and MATTER, the premier healthcare incubator and innovation hub, announced the launched of a new incubation program called AWS Expand. - The program supports startups entering the US market from Europe, the Middle East, and Africa (EMEA) by providing expert guidance, mentorship, client connections, an extensive network within the healthcare industry, and more. AWS Expand’s First Cohort of 30 EMA Healthcare Startups The dual-track program will prepare Europe,
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How IoT Data Integration Helps Deliver Improved At-Home Healthcare in 2022

by Patricia (Pat) Black, Director of Technical Solutions at Cardinal Peak 06/16/2022 Leave a Comment

How IoT Data Integration Helps Deliver Improved At-Home Health Care in 2022

When it comes to your health and treatment, hospitals leverage a variety of sensors and instruments to collect the necessary information to monitor and diagnose your health status. With essential health data integrated into one platform, healthcare professionals are able to quickly and easily monitor critical care parameters, which allows them to make decisions and deliver the best possible patient care.  Comprehensive big-picture insight into various health parameters, such as a patient’s
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