Binita S. Ashar, MD, MBA, FACS, MAMSE
About
I help leadership teams make high-stakes decisions about surgical robotics, AI, and other novel surgical devices, and I offer regulatory diligence to investors evaluating companies in this space.
My current focus is connected surgery. Several technologies can each work as specified in the same operation, and the case can still fail with no one able to say why. I call this the unexplainable case, and I write and speak on how health systems and their technology partners can reconstruct it and learn from it.
I bring two vantage points to this work. I am a board-certified general surgeon, and I practiced before joining FDA and continued clinical work on a limited basis for much of my time there.
I served at FDA from 2000 to 2025. I joined as a medical officer reviewing device clinical trials, later directed the Division of Surgical Devices and, from 2019, was Office Director for Surgical and Infection Control Devices at the Center for Devices and Radiological Health. I led roughly 120 scientists, engineers, physicians, and surgeons across three divisions, overseeing premarket review and postmarket safety for general surgery, plastic surgery, and infection control devices marketed in the United States.
Clarity Surgical Advisors is independent by design. Clients work directly with me, and my advice draws on how FDA weighs evidence and how devices perform in the operating room.
Background
The portfolio included surgical robots, skin lesion analyzers, breast implants, surgical staplers, dermal fillers, acellular dermal matrices, wound care and hemostasis products, personal protective equipment, and AI-enabled systems. I was the Senior FDA Official overseeing the General and Plastic Surgery Devices Advisory Committee from 2013 through 2025. During the COVID-19 public health emergency I directed cross-agency work on infection control technologies and surgical supply.
In 2012, I received the FDA Frances O. Kelsey Award for Excellence and Courage in Promoting the Public Health, named for the FDA reviewer who kept thalidomide off the US market. The award recognized my leadership on breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), work that subsequently involved coordinating with international regulators and later led to a global product recall.
Earlier, from 2005 to 2006, I served as Special Advisor for Medicine and Public Health in the Office of Homeland Security Affairs, Office of the Vice President of the United States.
I hold an MBA from the Johns Hopkins Carey Business School. I founded Clarity Surgical Advisors in 2025.