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Global Medical Device Regulatory, Reimbursement, and Policy Review


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Latest from Market Pathways

Global Medical Device Regulatory, Reimbursement, and Policy Review

Regulatory & Reimbursement

What the Stark Law Changes Mean for Medtech

The recently-revised regulations to the Stark Physician Self-Referral Law have implications that extend beyond clinicians to medtech companies, particularly as the healthcare system increasingly evolves from volume to value-based programs. These expert healthcare attorneys explain why it is essential that medtech companies understand the full ramifications of this law’s current standards. By By Melissa Hudzik, Esq., and Jeff Weinstein, Esq., Wilson Sonsini Goodrich & Rosati.

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Latest from Market Pathways

Global Medical Device Regulatory, Reimbursement, and Policy Review


Regulatory & Reimbursement

Docs of the Month: IVDs a Strong Global Policymaking Focus in February

Sustained COVID-19 pressures continue to put IVDs in the spotlight—lab diagnostics were the most common topic of focus in February among global policy documents captured in Pathways’ Document Depot. A look at those docs and some other important releases from last month.

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CVRx: A Pioneering Reimbursement Strategy Pays Off

Now nearly 20 years old, CVRx may have switched its clinical focus, but it has remained committed to the importance of developing a reimbursement strategy early on, including collecting health economics data as part of its clinical studies. This outlier approach has paid off with the company receiving NTAP approval for increased reimbursement.

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