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The Medical Alley Podcast (Presented by Gamut One Studios)
Gain insights from leaders as they discuss their experiences guiding the organizations that make Medical Alley the epicenter of health innovation and care. Join us for conversations with top healthcare CEOs, startup entrepreneurs, and other experts in healthcare community who are doing innovative work right here in Medical Alley.
The Medical Alley Podcast (Presented by Gamut One Studios)
Navigating FDA Regulation, CMS Coverage, and AI in Medical Technology with Gardner Law
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Bringing a healthcare innovation to market takes more than a great idea. It takes navigating a complex and constantly changing regulatory landscape.
On this episode of the Medical Alley Podcast, we sit down with Mark Gardner, Nate Downing, and Amanda Johnston from Gardner Law to discuss the FDA and CMS issues facing medical technology and healthcare companies.
This conversation explores CMS’s Rapid program and changes to NTAP, FDA leadership and review priorities, and how AI may shape regulatory submissions. Learn practical perspectives on advertising, compliance, privacy risks and look ahead to emerging technologies such as wearables and brain-computer interfaces. Whether you’re building a healthcare company or following the future of medical innovation, this episode offers insight into the challenges and opportunities on the path from idea to patient.
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