ResApp Health, the developers of the world’s first smartphone-based diagnostic test for respiratory disease where one simply coughs into the phone and the machine learning-based algorithm diagnoses the underlying respiratory disease, has received CE Mark certification as a Class IIa medical device.Significance of CE Mark CertificationCE Mark certification indicates that ResAppDx-EU meets the essential requirements of all the applicable European regulations as a medical device and allows for the
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Medical Devices | FDA | News, Analysis, Insights - HIT Consultant
OSF Ventures Joins $35M Funding Round for Handheld, Exo Ultrasound Device
OSF Ventures, the investment arm of OSF HealthCare has joined a $35M Series B funding round to support medical device startup Exo Imaging that’s developing a breakthrough handheld, AI ultrasound device that will allow healthcare providers to make critical, real-time diagnostic decisions.Performance Ultrasound PlatformFounded in 2015, Exo (pronounced “Echo”) is bringing diagnostic-grade medical imaging to the pocket of every caregiver and clinician worldwide. The company is developing an
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Mercy Launches a Nationwide Real-World Evidence (RWE) Network to Pool De-Identified Patient Data
Mercy Technology Services (MTS), the information technology arm of St. Louis-based Mercy health system, has launched a nationwide real-world evidence network to pool clinical data for advanced analysis. The new initiative aims to create a new model of curated data sharing among providers, drug and device makers, regulators and more to power better patient care.MTS Real-World Evidence (RWE) Network BackgroundDeveloped in partnership with global tech giant SAP, MTS’ new network aims to tap into
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What’s AI’s Holdup in Healthcare? The Answer Is In The Cloud
Fabien Beckers, Ph.D., CEO, Arterys
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
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What Is The Upside of Establishing Extended Reality As A Medical Device?
Eran Orr, Founder of XRHealth
XR stands for extended reality. Basically, it's an umbrella term covering the VR (virtual reality), AR (augmented reality), and MR (mixed reality) technologies. All three are already involved or will be involved in healthcare. In the very near future, you will be able to “swipe” between all three within an application. Different combinations of the technologies will be used to provide specific health benefits, eventually all within a single platform.
It is
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UK Startup Flow Raises $1.5M for Brain Stimulation Headset, Therapy App
Flow, a London-based medical device startup using a brain stimulation headset and therapy app to treat depression has raised $1.5 million in seed funding led by Khosla Ventures. In Europe, Flow has been approved as a Class II medical device intended for use as a treatment for depression – and is the first approved treatment of its kind in Europe available to buy and use at home. The investment will be used to support Flow’s European rollout, introduce Flow to healthcare clinics, and fund
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Procyrion Raises $30M to Support Clinical Trials of its Percutaneous Blood Pump Device
Procyrion, Inc., a Houston-based medical device firm developing the first catheter-deployed, intra-aortic pump initially for use in cardiorenal syndrome patients announced it has raised $30 million in Series D funding led by Bluebird Ventures. The round also includes participation from existing investors Fannin Partners, Scientific Health Development, the State of Texas, and an undisclosed strategic investor.The company is developing its AortixTM system, a percutaneous blood pump initially
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FDA Recalls Medtronic MiniMed Insulin Pumps for Potential Cybersecurity Risks
The U.S. Food and Drug Administration (FDA) is recalling certain Medtronic MiniMed insulin pumps due to potential cybersecurity risks and recommends that patients using these models switch their insulin pump to models that are better equipped to protect against these potential risks. To date, the FDA is not aware of any confirmed reports of patient harm related to these potential cybersecurity risks.Medtronic's MiniMed Insulin PumpsThe FDA is concerned that, due to cybersecurity vulnerabilities
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Syqe Medical Releases Pharmaceutical-Grade Medical Marijuana Inhaler
Syqe Selective-Dose Inhaler
Syqe Medical, an Israeli pharma-tech company, recently launched its newest administering device for cannabis in the form of a non-combustion inhaler.
The Syqe Inhaler™ is the company’s flagship product that utilizes innovative technology to administer proper doses of cannabis for medical marijuana patients in Israel. Syqe’s breakthrough drug delivery technology introduces complex respiration technique automation, electronic selective dosing, remote clinical
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NextGate Integrates EMPI with Life Image’s Clinical & Imaging Data Network
NextGate, a provider of healthcare enterprise identification, and Life Image, a global network for sharing clinical and imaging data that is powered by industry leading interoperability standards, today announced a strategic partnership to meet the increasing demand for reliable imaging workflow integration.Global-Sharing Network of Clinical, Imaging, Medical Device and Pharmaceutical DataEliminating silos and ensuring that each patient has one and only one record, NextGate and Life Image will
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