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Regulatory Affairs

Learn more about our Regulatory Affairs work.

Coverage & Payment / Regulatory Affairs / Small Business

Rhaeos, Inc. Awarded $4 Million NIH SBIR Grant to Expand Quantitative Measurement Capabilities of its FlowSense™ Noninvasive Wireless Sensor

Rhaeos, Inc., a private medical device company focused on the care of patients with hydrocephalus, announced today it was awarded a $4 million, multi-year grant from the National Institutes of…

Coverage & Payment / Regulatory Affairs / Small Business

Vibrato Medical Closes $4M Series A Funding Round and Receives $1.5M NIH Grant

Vibrato Medical, an innovator in the treatment of peripheral arterial disease (PAD), announced today that it has closed a $4M Series A funding round led by the Horowitz Group, a…

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Coverage & Payment / Government & Legislative Affairs / Regulatory Affairs

Top Medtech Venture Investor Justin Klein Discusses the Importance of MCIT Rule & Delivering Innovative Technologies to Patients

Justin Klein recently joined AdvaMed® CEO Scott Whitaker for an episode of Medtech POV to talk about his expansive career in medtech and some of today’s most pressing issues across…

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Navigating Patent Risk and Protecting Your Revenue Model in Medical Device Technology Webinar

September 7, 2021
12:00 PM - 1:00 PM

Learn about how recent developments in patent law affect FTO assessments.

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Government & Legislative Affairs / Regulatory Affairs

Federal Net Operating Losses: One Tax Reform Issue Patients Should Know

Well-crafted tax policy on NOLs spurs innovation in new life-saving treatments and cures; and as we continue to emerge from the pandemic, there is no time more important for the…

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Online

Breakthrough Device Designation: Understanding Regulatory and Reimbursement Implications Webinar

August 4, 2021
12:00 PM - 1:30 PM

ADVAMED EVENT — This timely webinar focused on the FDA breakthrough devices program and the implications for payment and coverage.

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Government & Legislative Affairs / Regulatory Affairs

FTC: When it Comes to the Medical Technology Industry – First, Do No Harm

As medtech and the health care system drive us closer to the pandemic’s end, reflexive and ill-conceived antitrust policy targeting medical technology companies risks thwarting innovation, foreclosing patient access to…

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U.S. Health Care Enforcement: Priorities and Key Regulatory Developments Webinar

June 16, 2021
1:00 PM - 2:00 PM

Join us for our webinar with Sidley Austin to better understand the current health care enforcement landscape with the new administration.

Global & Trade / Government & Legislative Affairs / Regulatory Affairs / Supply Chain

AdvaMed® Encourages Administration to Prioritize Transport of Medical Supplies

President and CEO of AdvaMed® Scott Whitaker sent a letter to President Biden on behalf of the medical technology industry asking “the Administration to make the transport of medical supplies…

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Navigating China’s New Regulatory Policy: Order 739 Webinar

June 28, 2021
8:00 PM - 9:30 PM

Join us for our webinar with Sidley Austin and China Med Device for a comprehensive overview of China’s new regulatory policies.

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