What You Should Know:
- Iterative Scopes, a pioneer in precision medicine technologies for gastroenterology, and Provation, the premier software and SaaS provider of clinical productivity and workflow automation solutions, announced recently that SKOUT™ has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for adults undergoing colorectal cancer screening or surveillance.
- The device was evaluated in the largest U.S.-based multicenter clinical study for a
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FDA Clearance
Eko Lands $2.7M NIH Grant to Train Pulmonary Hypertension AI
What You Should Know:
- Eko, a digital health company applying machine learning in the fight against heart and lung disease, today announced that it was awarded a $2.7M Small Business Innovation Research (SBIR) Direct Phase II grant by the National Institutes of Health’s (NIH) Department of Health and Human Services (HHS).
- The grant will fund the development of a machine learning algorithm that detects and stratifies pulmonary hypertension (PH) using phonocardiogram (PCG) and
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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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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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Fitbit Receives FDA Clearance for New PPG Algorithm to Identify AFib
What You Should Know:
- Fitbit announced it has received clearance from the FDA for its PPG (photoplethysmography) algorithm to identify atrial fibrillation (AFib), a condition that affects more than 33.5 million people globally.
- The algorithm will soon be available to users in the U.S. through Fitbit’s new Irregular Heart Rhythm Notifications feature on eligible heart-rate tracking devices.
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Arterys Receives FDA Clearance for Next-Gen Cardiac MRI App
What You Should Know:
- Arterys, the world's leading vendor-neutral artificial intelligence (AI) platform, has announced several new modules to its already robust Cardio AI clinical application and an additional FDA AI clearance based on deep learning.
- Cardio AI is a comprehensive, cloud-based post-processing solution that leverages AI and deep learning to provide extremely accurate, automated, fast, repeatable analysis of cardiac MRI images.
Cardio AI: AI-Assisted Cardiac MRI
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Precision Medicine Startup Prenosis Raises $20M for Acute Care Solutions, Starting with Sepsis
What You Should Know:
- Prenosis, Inc., a precision medicine company, announced a venture investment from PACE Healthcare Capital, an early-stage investment firm committed to improving health outcomes. This investment brings total funding in the company to over $20 million, including partnerships with Foxconn, Roche Diagnostics, the Defense Threat Reduction Agency, and others.
- Precision medicine company will use the funding to
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MediView XR Secures $9.9M for Augmented Reality Surgical Navigation Platform
What You Should Know:
- MediView XR, Inc., raises $9.9M in SAFE financing syndicated by Inside View Investments, LLC, a private investment firm. MediView has raised approximately $14.4MM in total funding to date.
- Investment will support key technology development, commercialization and regulatory submissions.
MediView XR Inc., a Cleveland-based medtech company that leverages augmented reality, remote connectivity and spatial computing data to create revolutionary surgical
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Cardiologs Awarded FDA Clearance for Pediatric Use of Algorithm
What You Should Know:
Cardiologs announced today that the FDA has cleared their algorithm to be used for the pediatric population - younger than 18. Their technology can now analyze ECG readings for atrial arrhythmias across all age groups.
Cardiologs, a medical technology company committed to transforming cardiac diagnostics using medical-grade artificial intelligence and cloud technology, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA)
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Biofourmis Earns FDA Breakthrough Device Designation for Digital Therapeutic for Heart Failure
What You Should Know:
- Biofourmis, a Boston-based global leader in virtual care and digital therapeutics, announced its BiovitalsHF® solution is the first-ever heart failure digital therapeutic to receive a Breakthrough Device designation from the U.S. Food and Drug Administration (FDA).
- The Breakthrough Devices Program was created to provide patients and providers with timely access to medical devices (in this case, software as a medical device, or SaMD) by speeding up their
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