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FDA and CMS Propose RAPID Collaboration to Bridge Initial Coverage Challenges for Novel Medical Devices

FDA and CMS Propose RAPID Collaboration to Bridge Initial Coverage Challenges for Novel Medical Devices

by Mridul Mittal | Apr 27, 2026 | News

By : Elle Winn & Susan Lubejko PhD- Mittal Consulting On Thursday April 23, the United States Food and Drug Administration (FDA) and Centers for Medicare & Medicaid Services (CMS) announced a new, expedited Regulatory Alignment for Predictable and Immediate...
Making AI-Powered Healthcare Mainstream: What the Health Tech Investment Act (S.1399) Means for AI-Device Developers 

Making AI-Powered Healthcare Mainstream: What the Health Tech Investment Act (S.1399) Means for AI-Device Developers 

by Mridul Mittal | Jul 9, 2025 | News

By- Anya Bekhtel (Mittal Consulting) Artificial intelligence and machine learning are driving innovation throughout healthcare, creating opportunities for faster and more accessible treatment solutions. While the FDA has authorized hundreds of AI and ML enabled...
What We’re Expecting to See at MedTech World Bay Area 2025

What We’re Expecting to See at MedTech World Bay Area 2025

by Mridul Mittal | Jun 13, 2025 | News

WHAT : Medtech World Bay Area Event WHERE : Signia Hotel by Hilton, San Jose                170 S Market St, San Jose, CA 95113 WHEN: June 27th, 2025 MedTech World Bay Area 2025 is just around the corner, and as the premiere regulatory affairs partner for startups in...
FDA Revamps Q-Sub Process with New Guidance and Digital Submission Template

FDA Revamps Q-Sub Process with New Guidance and Digital Submission Template

by Mridul Mittal | Jun 4, 2025 | News

By- Elle Winn (Mittal Consulting) FDA Revamps Q-Sub Process with New Guidance and Digital Submission Template On May 29, 2025, the U.S. Food and Drug Administration (FDA) released two significant guidances related to the Q-Submission (Q-Sub) Program for medical...
Siloam Vision Earns Breakthrough Device Designation for OCT Technology Aimed at Preventing Infant Blindness

Siloam Vision Earns Breakthrough Device Designation for OCT Technology Aimed at Preventing Infant Blindness

by Mridul Mittal | May 13, 2025 | News

May 14, 2025 Since 2021, Siloam Vision has been pioneering clinical solutions to prevent blindness and improve global vision health. Retinopathy of Prematurity (ROP) is a leading global cause of permanent infant blindness, particularly in regions with limited access...
Navigating the New Trade Terrain: What U.S. Tariffs Mean for Medtech Investors and Startups

Navigating the New Trade Terrain: What U.S. Tariffs Mean for Medtech Investors and Startups

by Mridul Mittal | May 5, 2025 | News

By- Elle Winn (Mittal Consulting) It is no secret that the new administrations pivot to an aggressive tariff strategy, including a 145% duty on goods from China and 10% baseline tariff for most other countries, has created a higher-stakes environment for the U.S....
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  • FDA and CMS’ Updates to the Proposed RAPID Reimbursement Pathway Further Narrow Eligibility to Access Coverage Support
  • NTAP/TPT Alternative Reimbursement Pathway Repealed for Breakthrough Devices – A Blow to Medical Device Innovation
  • Wave Neuro Introduces Individualized TMS Therapy for PTSD Using an Unconventional 510(k) Approach
  • MDUFA VI (FY 2028-2032) Newly Proposed FDA Pre-Submission Fee
  • It is a Marathon, not a Sprint: Lessons from SNOO’s FDA Warning Letter
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