The FDA stepped back. Now, organizational governance is the only thing standing between innovation and liability.

At CES 2026, the FDA officially announced it won't regulate wellness devices or Clinical Decision Support tools—removing approval bottlenecks and accelerating innovation. But this regulatory shift transfers responsibility to healthcare organizations themselves. Who builds the frameworks for data management when there's no FDA requirement? How do health systems justify physician time reviewing continuous patient streams without reimbursement pathways? And where does liability fall in this new landscape?

In this episode, Dr. Junaid and Ed tackle the AI governance vacuum, exploring how healthcare AI agents can scale care, from filtering patient data to managing population health. They share J.P. Morgan Healthcare Conference updates on why organizational trust, rather than just regulatory stamps, is the key to successful AI in healthcare.

What You Will Discover:

- What changed in the regulatory landscape?

- How the shift affects clinician workflows

- Who should pay for clinical data platforms?

- JPM Conference Insights

- The importance of governance and trust

- Biologics, biosimilars, and China competition

- Practical strategies for continuous learning

Referenced in the show:

🖇️ "Supercharging a New FDA: Marty Makary on Science, Power & Patients" – https://www.youtube.com/watch?v=DBlOJpT9Y1Y

Connect with us:

Dr. Junaid Kalia, Neurocritical Care Specialist and Founder of Savelife.AI™

💼LinkedIn - https://www.linkedin.com/in/junaidkaliamd

🔗Website - https://www.junaidkalia.com/

📹YouTube - https://www.youtube.com/@junaidkaliamd

Dr. Harvey Castro, ER Physician, #DrGPT™

💼LinkedIn - https://www.linkedin.com/in/harveycastromd/

🔗Website - https://www.harveycastromd.com/

📷Instagram - https://www.instagram.com/harveycastromd/?hl=en

Edward Marx, CEO, Advisor

💼LinkedIn - https://www.linkedin.com/in/edwardmarx/

🔗Website - https://www.marxadvisory.com/

📹YouTube - https://www.youtube.com/@EdwardMarx

Visit our website:

https://signalandsymptoms.com/

Get advisory insights about Healthcare AI — at zero cost:

https://junaidkaliamd.substack.com/

AI transformation in healthcare isn't something happening to physicians—it's an evolution physicians can actively shape and lead.

In this episode, we introduce our host, Dr. Junaid Kalia, a practicing neurologist who experienced healthcare's systemic failures firsthand and decided to build the solution himself. As founder of SaveLife.AI, his journey embodies physician-led innovation: combining clinical expertise with entrepreneurial action to create real transformation. Joining the conversation are his sister, Dr. Saira Kalia (academic program director), and close friend, Dr. Danish Bhatti (angel investor/advisor), as they discuss the evolution from clinician to innovator—and why "action bias" matters more than perfect planning.

Join our panel of a private sector entrepreneur, an academic program director, and an angel investor/advisor for a peer-to-peer reality check on the barriers, breakthroughs, and lessons learned.

What You Will Discover:

- Meet the Panel: Neurologist, Psychiatrist, and Their Unconventional Journeys

- Why They Stepped Outside the Traditional Clinical Pathway

- The Reality of Physician-Entrepreneurship

- Reason Behind Execution Failure

- The Resistance & Barriers They Didn’t Expect

Connect with us:

Dr. Junaid Kalia, Neurocritical Care Specialist and Founder of Savelife.AI™

💼LinkedIn - https://www.linkedin.com/in/junaidkaliamd

🔗Website - https://www.junaidkalia.com/

📹YouTube - https://www.youtube.com/@junaidkaliamd

Dr. Harvey Castro, ER Physician, #DrGPT™

💼LinkedIn - https://www.linkedin.com/in/harveycastromd/

🔗Website - https://www.harveycastromd.com/

📷Instagram - https://www.instagram.com/harveycastromd/?hl=en

Edward Marx, CEO, Advisor

💼LinkedIn - https://www.linkedin.com/in/edwardmarx/

🔗Website - https://www.marxadvisory.com/

📹YouTube - https://www.youtube.com/@EdwardMarx

Special Guest:

Saira Kalia, MD, Associate Professor, Arizona & Pediatric & Perinatal Psychiatry

💼LinkedIn - https://www.linkedin.com/in/saira-kalia-md-60685a132/overlay/about-this-profile/

Danish Bhatti, MD, Serial Entrepreneur and Angel Investor in Healthcare Startups

💼LinkedIn - https://www.linkedin.com/in/danish-bhatti/

Visit our website:

https://signalandsymptoms.com/

Get advisory insights about Healthcare AI — at zero cost:

https://junaidkaliamd.substack.com/

Drug development today forces patients to fit standard medications—but what if we could reverse that paradigm and design treatments tailored to each patient's unique biology?

This episode explores how specialized AI cloud infrastructure is transforming drug discovery and healthcare research–not as a distant future possibility, but as tools available to researchers today. Joining the conversation is Dr. Ilya Burkov, who shares how the right computational foundation and HPC tools accelerate scientific breakthroughs at AI speed.

The conversation reveals a significant shift in accessibility: junior researchers without specialized training now achieve 80-90% success rates in complex CRISPR experiments using agentic AI systems. These results once required years of expertise. Small research teams and startups can now access the same cutting-edge infrastructure as major pharmaceutical companies. This democratization directly impacts clinical practice: drug development timelines are compressing from decades to months, which means personalized treatments tailored to individual biology could become available within your career timeline.

It's not just about raw infrastructure efficiency. It's about the combination of technology, accessibility, domain expertise, and white-glove support that together transform what's possible in healthcare innovation.

What You Will Discover:

- Dr. Burkov: Bridging Biology and AI Infrastructure

- Nebius: AI Cloud for Drug Discovery, Genomics, Health Tech

- Scaling Personalized Patient Medicine

- Expert Support vs. Generic Clouds

- AI Success for Junior Researchers

- AI in Drug Discovery

- Nebius On Democratizing Latest GPU Access

- Future: Predicting Individual Patient Outcomes

Referenced in the show:

🖇️ "CRISPR-GPT for agentic automation of gene-editing experiments" – https://pubmed.ncbi.nlm.nih.gov/40738974/

Connect with us:

Dr. Junaid Kalia, Neurocritical Care Specialist and Founder of Savelife.AI™

💼LinkedIn - https://www.linkedin.com/in/junaidkaliamd

🔗Website - https://www.junaidkalia.com/

📹YouTube - https://www.youtube.com/@junaidkaliamd

Dr. Harvey Castro, ER Physician, #DrGPT™

💼LinkedIn - https://www.linkedin.com/in/harveycastromd/

🔗Website - https://www.harveycastromd.com/

📷Instagram - https://www.instagram.com/harveycastromd/?hl=en

Edward Marx, CEO, Advisor

💼LinkedIn - https://www.linkedin.com/in/edwardmarx/

🔗Website - https://www.marxadvisory.com/

📹YouTube - https://www.youtube.com/@EdwardMarx

Special Guest:

Dr. Ilya Burkov, Global Head of Healthcare & Lifesciences at Nebius

💼LinkedIn -