Insights
The medtech landscape is always moving, and every shift shapes the decisions behind the devices in development today. Mittal Consulting’s insights bring a clear perspective to where the industry is heading and what it means for the companies building within it.
Articles
FDA and CMS’ Updates to the Proposed RAPID Reimbursement Pathway Further Narrow Eligibility to Access Coverage Support
By: Susan Lubejko PhD and Abigail Copeland PhD, Regulatory Affairs Specialists at Mittal Consulting Earlier this year, in April 2026, FDA and the Centers for Medicare and Medicaid Services (CMS) announced the proposed establishment of the Regulatory Alignment for...
NTAP/TPT Alternative Reimbursement Pathway Repealed for Breakthrough Devices – A Blow to Medical Device Innovation
By: Susan Lubejko PhD and Abigail Copeland PhD, Regulatory Affairs Specialists at Mittal Consulting On Tuesday August 4, the Centers for Medicare & Medicaid Services (CMS) finalized the repeal of the alternative pathway for FDA-designated Breakthrough Devices...
Wave Neuro Introduces Individualized TMS Therapy for PTSD Using an Unconventional 510(k) Approach
By: Susan Lubejko PhD and Abigail Copeland PhD, Regulatory Affairs Specialists at Mittal Consulting For both drugs and devices, personalized therapies that target specific patient biomarkers and tailor treatments to individual biological needs are the next big...
Webinars
Supporting MedTech Startups from Day One | MedTech World
Regulatory to Revenue: MedTech Strategy | MedTech World
Decoding FDA Regulations: Pitfalls and Pearls for Medtech Entrepreneur | Georgia Tech
Podcasts
Regulatory Consultant vs. Regulatory Strategist | Project Medtech Podcast
US FDA Pre-Submissions Best Practices for Early-Stage Startups and Small Businesses | Journal of Medical Device Regulation Podcast
Interview with Kristen Mittal, Co-Founder & CEO of Mittal Consulting | She Leads Biotech Podcast
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