About

Clarity Surgical Advisors addresses a persistent structural gap in surgical innovation. Technologies advance rapidly, yet the regulatory, clinical, and accountability systems required to support their safe integration often evolve more slowly.

In complex surgical domains including robotics, oncologic and ablative technologies, plastic and reconstructive devices, aesthetic technologies, and infection control, technical performance alone does not determine success. Outcomes are shaped by how evidence is generated, how regulatory positioning is framed, and how responsibility and risk are managed once devices enter routine clinical practice

Clarity Surgical Advisors is led by Binita S. Ashar, MD, MBA, FACS, MAMSE, a board-certified general surgeon and former Director of the FDA Office of Surgery and Infection Control Devices. With nearly 25 years of federal service, including prior service in the White House, she has held senior regulatory roles overseeing surgical and infection control technologies, AI-enabled diagnostics, breast implants, dermal fillers, and ablative cancer devices.

Her work informed regulatory decisions, advisory committee deliberations, postmarket safety investigations, and national health policy at moments of significant clinical and reputational consequence. She is among the very few surgeons to have led federal regulatory decision-making for the same categories of technologies she used in clinical practice.

Background

Dr. Ashar presided over FDA advisory committee meetings on robotic surgery, breast implant safety, surgical staplers, dermal fillers, and AI-assisted technologies. She held senior regulatory responsibilities during a period of significant growth and evolution in U.S. soft tissue robotics, ensuring appropriate evidentiary and safety standards as new entrants emerged.

She directed cross-agency efforts during the COVID-19 pandemic to maintain access to infection control technologies and essential surgical supplies.

She now advises executive teams and founders developing complex surgical and medical technologies, bringing direct experience from inside the federal decision-making process to consequential regulatory and clinical decisions.

Selected Work and Contributions

Presided over FDA General and Plastic Surgery Devices Advisory Committee for over a decade, including robotic surgery, breast implant safety, surgical staplers, dermal fillers, and AI-assisted technologies

Held senior regulatory responsibilities during a period of significant growth in U.S. soft tissue robotics ensuring appropriate evidentiary and safety standards as new entrants emerged.

Directed cross-agency infection control and PPE regulatory response during the COVID-19 public health emergency

Lead author or spokesperson for national FDA safety communications on breast implants, infection control technologies, and emerging surgical devices

Invited plenary speaker at national and international surgical and device innovation meetings and U.S. medical school commencement

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

FDA - Public communications on breast implants (videos for providers and patients)

JAMA - Radiofrequency Identification Technology in Health Care

About

Background

Selected Work and Contributions

Selected Publications and Media

The readiness gap

Breakthrough medical technologies rarely fail because the science is inadequate. They fail when regulatory, clinical, and operational readiness lag behind technical capability.

Readiness requires evidence that reflects procedural variability, workflows aligned with real-world practice, clear accountability for safety, and risk management that anticipates use beyond controlled development.

Clarity Surgical Advisors advises executive teams and founders at critical points, where regulatory expectations, clinical reality, and operational risk converge.

What I Advise On:

Regulatory and Evidence Strategy at Pivotal Moments

Designing claims, evidence plans, and regulatory pathways aligned with how FDA decisions are made, particularly when feedback threatens indications, labeling, or commercial positioning.

Clinical Readiness Before Broad Adoption

Structuring workflow, training, human factors, and accountability frameworks so technologies are prepared for routine surgical use, not just controlled development.

Independent Regulatory and Clinical Risk Assessment

Providing independent evaluation of regulatory positioning, evidentiary sufficiency, and postmarket exposure across surgical robotics, oncologic and ablative platforms, plastic and reconstructive surgery devices, aesthetic technologies, and infection control.

Executive Advisory at High-Consequence Decision Points

Advising executive teams and founders when regulatory, clinical, commercial, and reputational stakes converge.

Organizations Often Reach Out When:

A novel surgical or interventional technology reaches its first consequential regulatory or clinical decision, and feedback is ambiguous or threatens labeling.

Material questions about claims, evidence strategy, or pathway arise, and internal alignment begins to fracture.

Evidence plans no longer reflect real-world surgical practice or procedural variability.

Transitioning from controlled development into routine clinical use introduces new operational or safety risk.

Safety signals prompt questions about accountability, oversight, or public communication strategy.

Executive leadership seeks independent judgment grounded in regulatory and surgical experience.