Ohad Peled, Product Marketing Manager at Sony Semiconductor Israel
The global home medical equipment market is experiencing explosive growth. Smart devices are being used to monitor and treat patients suffering from diabetes, cardiac disorders, and…
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Margaret Nardini, Healthcare Product Manager at Accruent
The complexity and cost of medical devices are escalating, and with it, the stakes for maintaining these assets efficiently and compliantly are increasing. In some cases, this requires…
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The MedTech industry is accelerating at an unprecedented pace. As AI reshapes the landscape, global collaborations are expanding, and the regulatory frameworks are evolving to meet new challenges. Here are ten global MedTech trends…
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Joseph M. Saunders, Founder and CEO, RunSafe Security
Medical device manufacturers face a conundrum. To meet recent FDA requirements, which were initially introduced a little over a year ago, they now need to quickly provide…
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The Medicines and Healthcare Products Regulatory Agency (MHRA) has issued fresh guidance to help medical device manufacturers prepare for upcoming regulatory changes.
The post-market surveillance (PMS) regulation for medical devices comes into force across England,…
What You Should Know:
– Percipio Health, a population health monitoring and management platform, today announced its official launch and the closing of a $20M in Series A funding round led by UPMC Enterprises, WAVE…
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Groundbreaking AI Healthcare Regulations Unveiled
The U.S. Food and Drug Administration (FDA) has initiated a transformative step in healthcare technology by releasing comprehensive draft guidance for AI-enabled medical devices on January 6, 2025. This pioneering…
Recent research shows almost half of U.S. counties don’t have a practicing cardiologist. The fact that more than 22 million Americans must travel nearly 90 miles round trip to seek this expertise should be…
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Obstructive sleep apnea (OSA) is a serious, chronic sleep-related breathing disease that impacts an estimated 80 million people in the United States and nearly 1 billion globally. Untreated OSA carries profound health and quality-of-life…
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Essential FDA Guidelines Transform AI Medical Devices
Revolutionary Changes in Medical Device Regulation
The U.S. Food and Drug Administration is introducing groundbreaking marketing submission recommendations for AI-enhanced medical devices. These guidelines will provide comprehensive oversight throughout…
