
This white paper, “Connected Medical Devices”, explores the transformative impact of integrating Bluetooth Low Energy (BLE), mobile apps, cloud platforms, and AI/ML into medical devices. It highlights the benefits of real-time data exchange, remote monitoring, and enhanced clinical decision-making while addressing challenges such as security, FDA compliance, and data management. The document includes a case study on an implantable neural stimulator, outlines key design considerations, and discusses mobile and cloud-based platforms for connected healthcare solutions. Developed by Sunrise Labs, the paper provides insights into engineering best practices for next-generation medical devices.
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WASHINGTON, D.C.—AdvaMed, the medtech association, today announced a town hall featuring FDA Center for Devices and Radiological Health (CDRH) Director Michelle Tarver and fellow CDRH senior leaders at The MedTech Conference hosted by AdvaMed in San Diego in October. The town hall participants will update the audience on the center’s strategic direction and priorities and take questions.
Event / Digital Health / research & policy papers
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AdvaMed in Action: Legal, Compliance, and Regulatory in the Spotlight at The MedTech Conference 2025
August 27, 2025
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AdvaMed, Patient Groups, State Medtech Associations Urge Medicare Coverage of Breakthrough Medtech
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AdvaMed Welcomes MDUFA VI Discussion Kickoff at FDA Public Meeting
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WASHINGTON, D.C.—AdvaMed, the medtech association, today welcomed the kickoff of the latest Medical Device User Fee Amendments (MDUFA) discussion at a public meeting at FDA headquarters. Three AdvaMed senior staff members encouraged the agency to build on the successes of the prior five such agreements to ensure the next agreement, MDUFA VI, delivers strong results for the American public.
News / Digital Health / Government & Legislative Affairs
AdvaMed Welcomes Administration’s Health Data Sharing Pledge
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AdvaMed, the medtech association, released the following statement today from Shaye Mandle, executive director of the organization’s Digital Health Tech division, on the announcement from the White House, CMS, and HHS of a voluntary pledge by health care entities to make patient data more accessible and delivered faster between patients and providers.
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ICYMI: AdvaMed Op-ed on the Vital Role of Medtech in Making Americans Healthy Again
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WASHINGTON, D.C. – In a new op-ed in The Washington Times, Scott Whitaker, president and CEO of AdvaMed, the Medtech Association, laid out medtech’s vital role in the Trump administration’s “Make America Healthy Again” initiative, calling for policies that ensure faster, broader access to lifesaving medtech.
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AdvaMed Welcomes White House’s “America’s AI Action Plan”
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WASHINGTON, D.C.—Scott Whitaker, president and CEO of AdvaMed, the medtech association, issued the following statement on the White House’s “America’s AI Action Plan”: