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Regulatory Affairs

Learn more about our Regulatory Affairs work.

Nadim Yared sits at a meeting table with colleagues
Regulatory Affairs / Small Business

CVRx CEO Nadim Yared Joins Podcast in Two-part Episode to Discuss the Latest in Cross-Sector Collaboration and Startup Leadership

Recently, Nadim Yared joined host Scott Whitaker on the Medtech POV Podcast in a 2-part episode to discuss his expansive career, transition to a startup company and work with the…

COVID-19 / Government & Legislative Affairs / Regulatory Affairs

BD Unveils Nebraska-Based Manufacturing Capacity to Support U.S. Vaccination Agility and Preparedness

BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced it has strengthened the U.S. government’s access to safety injection devices through increased manufacturing capacity…

Coverage & Payment / Regulatory Affairs / Small Business

Bluegrass Vascular Announces Decision by Medicare to Assign a New Technology Ambulatory Payment Classification (APC) for the Surfacer® System Procedure

Bluegrass Vascular Technologies (Bluegrass Vascular), a private medical technology company focused on innovating lifesaving devices and methods for vascular access procedures, announced today that the Centers for Medicare & Medicaid…

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…

Two senior women laughing together on a park bench
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…

tablet, notepad, and data charts spread across desk
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…

two doctors in operating room
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…

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…

device technician repairs technology with tools
Government & Legislative Affairs / Regulatory Affairs

The Problems State Right-to-Repair Statutes Pose for Patients and Hospitals

The long-term implications of state right-to-repair laws could have devastating consequences for health care providers and their patients.

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