About

Companies developing surgical robotics, AI-enabled devices, aesthetic devices, and other advanced procedural technologies often reach pivotal points where regulatory strategy, clinical evidence, and real-world use must align. Decisions at these moments can determine not only regulatory outcomes, but also clinical adoption, labeling and long-term risk.

Clarity Surgical Advisors works with executive teams at these critical junctures.

Led by Binita S. Ashar, MD, MBA, FACS, MAMSE, a board-certified general surgeon and former FDA Office Director, the firm brings 25 years of FDA leadership and clinical experience to high-consequence strategic questions.

Dr. Ashar led federal regulatory oversight for surgical, reconstructive, and aesthetic device categories including breast implants, surgical staplers, soft tissue robotics, and other complext technologies where clinical reality and regulatory judgement must hold together.

Background

At the FDA, Dr. Ashar led regulatory policy and review for surgical, reconstructive, aesthetic, and infection control technologies, including robotic surgery, breast implants, surgical staplers, dermal fillers, wound care, hemostasis products, and AI-assisted systems.

Her work helped shape national regulatory decisions, advisory committee deliberations, postmarket safety evaluations, and policy during periods of significant clinical, public health, and reputational consequence.

During the COVID-19 public health emergency, she directed cross-agency efforts to maintain access to infection control technologies and essential surgical supplies.

She also served in the White House and brings nearly 25 years of federal leadership and clinical experience to high-consequence device strategy.

Selected Work and Contributions

  • Led FDA oversight of surgical, reconstructive, aesthetic, and infection control device categories during periods of rapid technological change and heightened public scrutiny.

  • Presided over General and Plastic Surgery Devices Advisory Committee deliberations for more than a decade, including issues involving robotic surgery, breast implant safety, surgical staplers, dermal fillers, and AI-enabled technologies.

  • Helped shape evidentiary and safety expectations during a period of significant growth in U.S. soft tissue robotics.

  • Directed cross-agency regulatory response during the COVID-19 public health emergency to help maintain access to infection control technologies and essential surgical supplies.

  • Served as a national FDA spokesperson on device safety issues involving breast implants and other emerging surgical technologies.

Selected Publications and Media

Journal of Robotic Surgery - National telerobotic surgery framework

Johns Hopkins Public Health On Call - Advancing Robotic Telesurgery

FDA - Statements on breast implant safety and lymphomas