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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FDA| Healthcare FDA Regulation | Policy, News, Analysis, Insights - HIT Consultant
Caption Health Receives CE Mark for AI Ultrasound Tech
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
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
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
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?
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
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
- 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
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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4 Steps for Operationalizing the FDA’s Call To Improve Health Outcomes for All Patients
In April, FDA Commissioner Dr. Robert Califf laid out areas of challenge and opportunity when it comes to improving health outcomes, restoring public trust in science, and making the most of our ongoing investments in data analytics and clinical research. More specifically, Califf made clear that our current healthcare system is “very well aligned to improve outcomes for some people and not others.”
Califf went on to note that we need better mechanisms for evidence generation
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