FDA

Hillcrest Medical Center Is First To Use Newly Approved Heart Treatment Device

Hillcrest Medical Center is the first to use a newly approved heart treatment device

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A device used for the first time in the world by cardiologists at the Oklahoma Heart Institute at Hillcrest Medical Center has received FDA clearance. “Our goal at Oklahoma Heart is really to bring new devices and technology to Tulsa and northeast Oklahoma and surrounding communities. So patients don’t have to suffer or they don’t …

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Epic's revised sepsis model, Verily's strong ties to the FDA and AI for biopsies

Epic’s revised sepsis model, Verily’s strong ties to the FDA and AI for biopsies

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You’re reading the web edition of STAT Health Tech, our guide to how technology is transforming the life sciences. Sign up to receive this newsletter in your inbox every Tuesday and Thursday. Epic revises sepsis model amid scrutiny The Wisconsin health records giant is revamping its flagship sepsis prediction model following Casey’s investigations revealing high …

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Human Factors Methodology in Medical Device Design for FDA Approval

Human Factors Methodology in Medical Device Design for FDA Approval

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By Sean Hägen, Founder and Director of Research and Synthesis, BlackHägen Design Human Factors Engineering (HFE) must be considered by every medical device manufacturer at some stage of the design and development journey to ensure that the final product can not only gain FDA approval, but also meet the needs of users and patients. Regulatory …

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VA and FDA Partner to Accelerate Delivery of Medical Devices

VA and FDA Partner to Accelerate Delivery of Medical Devices

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The agencies will work together to create testing methods, tools and training that support medical device innovators throughout the product development cycle. WHY IS IT IMPORTANT Veterans Affairs personnel will provide the clinical context for test development while U.S. Food and Drug Administration personnel will assess the benefits and risks of medical devices to speed …

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Remote regulatory assessments: Pharma, device groups want more details on FDA guidelines

Remote regulatory assessments: Pharma, device groups want more details on FDA guidelines

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Regulatory news | September 28, 2022 | By Joanne S. Eglovitch Trade groups representing the pharmaceutical and medical device industries, while broadly supporting the use of remote regulatory assessments (RRAs) as outlined in recent draft guidance from the U.S. Food and Drug Administration (FDA), are asked how these assessments would work in practice, including how …

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In new guidance, FDA says AI tools to warn of sepsis should be regulated as devices

In new guidance, FDA says AI tools to warn of sepsis should be regulated as devices

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JThe Food and Drug Administration on Tuesday released a list of artificial intelligence tools that should be regulated as medical devices, in some cases appearing to extend its oversight to previously unregulated software products. In a final new guidance for industry, the agency clarified that tools designed to warn caregivers of sepsis, a life-threatening complication …

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Louisville-based company receives FDA approval for injectable overdose reversal device

Louisville-based company receives FDA approval for injectable overdose reversal device

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LOUISVILLE, Ky. (WAVE) — Julie Hofmans’ Saturday afternoon ride on her horse, Hugo, means more than just overcoming obstacles. She came to Brownsboro Farm in Crestwood to participate in “The Pace” event in honor of her son, Wyatt Williamson. “[When I’m riding] I feel Wyatt,” Hofmans said. “I feel his strength” Williamson, 23, died on …

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