The U.S. Food and Drug Administration (FDA) has permitted marketing of the Tandem Diabetes Care t:Slim X2 insulin pump with interoperable technology (interoperable t:Slim X2) for delivering insulin under the skin for children and adults with diabetes. This new type of insulin pump, Referred to as an alternate controller enabled (ACE) infusion pump, or ACE insulin pump, is the first interoperable insulin pump, meaning it can be used with different components that make up diabetes therapy systems,
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FDA Clearance
IDx and Topcon Join Forces to Scale AI-based Diagnostic Platform in the U.S. Market
IDx, an AI diagnostics company, and Topcon, one of the world’s leading ophthalmic device manufacturers, have signed an exclusivity agreement that will allow the companies to scale delivery of AI-based diagnostic solutions in the U.S. market. As part of the agreement, is granted exclusive rights to IDx-DR system, an autonomous AI system that instantly detects diabetic retinopathy in fundus images, exclusively with Topcon NW400, an easy to use, robotic fundus camera. IDx-DR is an FDA-cleared
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DreaMed Diabetes Granted FDA Approval for Personalized Diabetes Decision Support Solution
DreaMed Diabetes, an Israeli-based developer of personalized diabetes management solutions, today announced that the U.S Food and Drug Administration (FDA) has granted a De Novo request for DreaMed Advisor Pro, an artificial intelligence (AI)-based diabetes treatment decision support software. Advisor Pro is indicated to assist healthcare providers in the management of people with type 1 diabetes who use insulin pumps and continuous glucose monitoring (CGM).The announcement marks the second
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Cardiac Monitoring Startup Eko Devices Raises $5M to Bring Intelligence to Heart Sounds
Eko, a San Francisco, CA-based platform of non-invasive cardiac screening devices, care coordination software, and machine learning algorithms has raised $5 million in Series A funding led by ARTIS Ventures. The round also included participation from Strategic Partners, Dreamlt Ventures, 1812 Ventures, and FOUNDER.org. Eko plans to utilize the funding to accelerate its commercial team and to expand clinical studies on the use of Eko's platform for valvular heart disease screening and heart
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Eko Duo Receives FDA Clearance to Market Combined Digital Stethoscope/ECG Smart Device
Eko Devices, a provider of mobile acoustic cardiac monitoring solutions has received FDA clearance to market its latest solution, Eko Duo, a smart heart monitor transforming how patients and their physicians monitor heart disease. Eko Duo combines the digital stethoscope and ECG for monitoring patients in the clinic or at home into a compact, handheld device.The DUO, which patients can obtain with a prescription, can seamlessly stream cardiac data (stethoscope + ECG) to specialists, providing
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Oxitone Medical Receives FDA 510(k) Clearance for Wrist-Sensor Pulse Oximetry Bracelet
Oxitone Medical (Oxitone), an Israeli-based medical device and digital health company developing wearable monitoring solutions has received 510(k) clearance from the FDA for its wrist-sensor pulse oximetry bracelet Oxitone 1000. The wrist-sensor pulse oximeter Oxitone 1000 measures critical vital signs such as SpO2 and pulse rate with the same precision as conventional fingertip pulse oximeters.The Oxitone solution has been validated in pilot studies in a number of medical settings including
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Philips Awarded FDA Clearance for Digital Pathology Solution for Primary Diagnostic Use
Today, Philips announced it has received regulatory clearance from the FDA (via De Novo classification) for its IntelliSite Pathology Solution, marking a significant leap forward for the pathology services industry in the U.S. De novo classification is the regulatory pathway for marketing clearance for novel, low- to moderate-risk medical devices that are the first of their kindAs the first and only digital pathology system to be approved for primary diagnostic use in the country, today’s news
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