What You Should Know:
- FDA expedites clearance of Caption Health’s AI-powered ultrasound solution to aid frontline healthcare workers in the fight against COVID-19 pandemic.
- Caption Health’s AI-guided imaging supports the assessment of cardiac function and decreases personnel exposure to novel coronavirus.
In response to the growing body of evidence demonstrating
the impact of COVID-19
on the heart, the U.S. Food and Drug Administration (FDA) has expedited
clearance of an update
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FDA Clearance
Lumos Diagnostics Raises $15M to Expand Point of Care Diagnostic Solutions Internationally
- Lumos Diagnostics raises $15M in Series A funding to support the international expansion of its point of care diagnostic solutions.
- Lumos provides assay development and manufacturing services for customized POC tests as well as directly develops, manufactures and will commercialize a suite of proprietary Lumos-branded POC tests that focus on the systemic host immune response.
Lumos Diagnostics, a Sarasota, FL-based health IT company, today announced it has raised $15M in Series A
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Sony Awarded FDA Clearance for Smart Operating Room Platform in the U.S.
- Sony announces FDA 510(k) clearance from the FDA for NUCLeUS™, the smart operating room platform, for sale in the U.S.
- NUCLeUS provides an enhanced, streamlined workflow for operating rooms and clinical spaces with direct access to imaging data from an easy-to-use central dashboard.
Sony Electronics has received FDA 510(k) clearance from the
Food and Drug Administration for the company’s NUCLeUS™
Operating Room, Imaging Management and Collaboration Control platform.
Proven in
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BioIntelliSense Awarded FDA 510(k) Clearance for On-Body Sensor for Scalable Remote Care
- BioIntelliSense announces FDA clearance of the BioSticker, the first single-use medical device enabling 30 days of continuous vital signs monitoring. - The FDA-cleared BioSticker medical device is designed to be discreetly worn on the upper left chest for effortless remote data capture and a simplistic “stick it on and forget it” patient experience. BioIntelliSense, Inc., a continuous health monitoring and clinical intelligence company, today announces the U.S. commercial launch of its
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FDA Breakthrough Status Granted for Heart Failure Algorithm by Eko
- 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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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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