- Eko announced the FDA has granted “breakthrough status” for an algorithm that could provide an easily accessible screening test for heart failure during routine physical exams.- This designation is awarded to novel innovations that demonstrate the potential to address unmet medical needs for life-threatening or irreversibly debilitating diseases. - Heart failure is often left untreated until it’s too late due to costs, inaccessibility to echocardiogram testing, or misdiagnosis. With nearly six
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FDA Clearance
Paige Raises $45M to Expand AI-Native Digital Pathology Ecosystem to Accelerate Biomarker Discovery
- Paige raises $45M in Series B funding led by Healthcare Venture Partners with participation from Breyer Capital, Kenan Turnacioglu, and others. - The funding will be used to accelerate commercial efforts of its AI-native digital pathology ecosystem in the U.S., Europe, Brazil, and Canada. Paige, a NYC-based leader in computational pathology transforming the diagnosis and treatment of cancer, today announced it has closed its Series B funding round of $45 million, bringing the Company’s
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Unlike Theranos: FDA Clears Sight Diagnostics’ Finger-Prick Blood Test for U.S. Market
- Sight Diagnostics, the company working to provide patients with lab-grade blood testing results in minutes, has received US FDA 510(k) clearance for its finger-prick blood test, OLO analyzer to be used in laboratories run by diagnostic providers and hospitals.
- Sight Diagnostics’ patented OLO analyzer digitizes blood into images to perform the most common blood test in minutes, from just two drops of blood
- The FDA clearance follows clinical trials at Boston Children’s Hospital,
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Heart Failure is Detectable at Point of Care Using ECG-Enabled Stethoscope, Mayo Clinic and Eko Finds
- Eko and Mayo Clinic announced they have proven that heart failure is detectable during routine physical exams, further validating the Eko DUO digital stethoscopes as a heart failure screening tool. - Today’s news marks the first time that a point of care device with a single lead ECG combined with an AI algorithm identified low ejection fraction in patients.- The results of these findings, which are comparable to research published earlier this year in NatureMedicine, were presented over the
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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
- 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
- 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
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
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
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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