By: Susan Lubejko PhD, Mittal Consulting The new year has brought big news on the mindset shift that FDA is taking regarding certain AI-powered digital health and wearable wellness products. Following an address to the Consumer Electronics Show in Las Vegas, FDA Commissioner Dr. Marty Makary joined the Fox Business show Varney & Co to […]
By: Anya Bekhtel, Mittal Consulting ‘With this new finalized guidance document, FDA has eliminated the requirement for real world evidence (RWE) supplied in marketing applications to mandatorily include identifiable, individual patient data, opening a host of datasets for use that were previously inadmissible.‘ On Monday December 15, 2025, the FDA announced that the Agency is […]
In hindsight, many of us underestimated just how severe the consequences of the recent FDA shutdown would be. While initial commentary focused on political brinkmanship, the real impact ran much deeper—touching patient safety, innovation pipelines, and the broader medtech ecosystem. Why We Were All Wrong At first, the assumption was that a temporary lapse in […]
The Neurotech Leaders Forum 2025, held at the Embassy Suites San Francisco Airport Oyster Point on November 5-6, 2025, convened top minds from the neuromodulation and neurotechnology sectors, including academic leaders, industry experts, investors, and entrepreneur innovators. The conference celebrated 25 years of editorial coverage from Neurotech Reports and showcased a dynamic agenda of keynote […]
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- Elle Winn (Mittal Consulting) March 12-13, 2025 Palo Alto Regulatory Shifts and Industry Insights The Medical Device Manufacturers Association (MDMA) hosted their annual FDA Forum on March 12-13, 2025 in Palo Alto, California. While FDA attendance was limited due to recent return-to-office (RTO) and budget policies, the event still brought in many industry members […]
17 February, 2025 Under the new US administration, there are rigorous changes, and we are already seeing direct impacts to all FDA branches, but disproportionately FDA device’s review branch, Center for Devices and Radiological Health (CDRH). In order to plan how to best adapt to these changes, we’d first like to present the changes that have […]
By: Elle Winn (Mittal Consulting) Exploring the Future of AI Medical Devices: FDA’s Predetermined Change Control Plan Offers Potential, but Challenges Remain Artificial Intelligence (AI) is continuing to grow at an awe-striking rate. As the artificial intelligence ecosystem continues to develop, we should expect to see AI continue with strong penetration into the med-tech sector. […]
