By: Elle Winn (Mittal Consulting) At 12:01 am ET on Wednesday, October 1, 2025, the US federal government began its government shutdown. With this shutdown, many are asking what it means for FDA operations, and especially the impacts on the medical device industry during this closure. For the Center for Devices and Radiological Health (CDRH), […]
By- Mridul Mittal, Co-founder & COO, Mittal Consulting Celebrating 5 Incredible Years of Mittal Consulting! What started during the uncertain days of the global pandemic has grown into a powerful, purpose-driven force within the medical device industry. Today, as we proudly celebrate 5 incredible years of Mittal Consulting. We reflect on a journey defined by […]
By: Anya Bekhtel (Mittal Consulting) FDA Launches Regulatory Accelerator to Empower Digital Health Innovators On July 24, 2025, the U.S. Food and Drug Administration (FDA) unveiled Regulatory Accelerator, an initiative intended to empower innovators on the journey of bringing digital health products to the US market. Regulatory Accelerator: A Centralized Resource for Success Regulatory Accelerator […]
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 devices over the last five years, the pathway to reimbursement for these systems has remained unclear. The Senate Artificial Intelligence […]
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 the medical device industry — and a […]
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 devices. These include the finalized guidance, “Requests for Feedback and Meetings for Medical Device Submissions: The […]
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 to adequate eye care. Driven by the belief that no child should lose their sight to […]
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. med-tech space. While for larger established companies, this means some cost pivots […]