What You Should Know:
– Amplitude Vascular Systems (AVS), a medical device company focused on safely and effectively treating severely calcified arterial disease with its novel PULSE IVL™ platform, announced today that it has completed a…
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Hong Kong-based startup PanopticAI has obtained regulatory approval in the United States for its contactless pulse rate measuring application. It received the US Food and Drug Administration’s 510(k) clearance for the PanopticAI Vital Signs app…
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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,…
Kyle Fetter, Chief Operating Officer at XiFin
The Kyle Fetter is the Chief Opearing Officer XiFin, a healthcare information technology company that empowers healthcare organizations to navigate an increasingly complex and evolving healthcare landscape. Fetter currently…
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What You Should Know:
– FIRE1, a connected medical device company, announced it has secured $120M in funding to advance its mission to transform the lives of millions of people living with heart failure. The…
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Are you a biopharma, medical device, diagnostic or health tech startup? Looking for active investors to advance your tech and grow your customer base? Would you like the chance to win a profile in…
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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…
What You Should Know:
– Wellumio, a New Zealand-based medical device innovator announced the launch of a new subsidiary in California, a strategic move aimed at facilitating US-based clinical trials for its groundbreaking Axana device…
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To support the continued development and marketing of safe and effective medical devices enhanced by artificial intelligence, the U.S. Food and Drug Administration will offer marketing submission recommendations, including the documentation and information needed…
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