SimBioSys announced that it received FDA 510(k) clearance for its TumorSight cloud-based digital precision medicine platform.
FDA clearance came just days after the company inked a partnership with Mayo Clinic to develop precision medicine solutions.
The TumorSight platform takes a patient’s standard-of-care imaging to build a custom 3D model of their tumor. The tool provides 3D spatial visualizations of breast cancer to support more effective planning and consultations. SimBioSys said it gives clinicians and patients a more comprehensive understanding of their cancer and the potential options available.
Additionally, the TumorSight application provides insights like tumor volume, tumor-to-breast volume and tumor distance to key anatomical structures. It quantifies key metrics required in treatment planning.
SimBioSys also plans to expand the TumorSight platform and incorporate a suite of innovative tools. Those tools could extend to surgical planning, treatment optimization and risk assessment. The company wants to deliver holistic support for the cancer care journey.
“This is a landmark moment for the SimBioSys team and our many collaborators. It is our springboard to begin fulfilling our mission to redefine precision medicine as we launch this first application and target further expansion in clinical utilities within breast cancer as well as across other solid tumors,” said Tushar Pandey, co-founder and CEO of SimBioSys.
SimBioSys also makes a personnel appointment
In addition to FDA clearance, SimBioSys announced the appointment of Jyoti Palaniappan as chief commercial officer (CCO).
Previous stops along the way for Palaniappan include roles at Abbott, Thermo Fisher Scientific and McKinsey.
SimBioSys says his responsibilities include steering the company through “a transformative phase” marked by the TumorSight launch. Additionally, he’ll oversee the accelerated development of additional clinical offerings and the expansion of the PhenoScope research product.
“We are thrilled to welcome Jyoti to the SimBioSys team,” Pandey said. “His extensive industry tenure and profound expertise will prove instrumental as we commercialize our technologies and pioneer novel approaches to understanding tumor biology. At this crucial juncture, Jyoti’s leadership will be invaluable in addressing real-world challenges within the cancer community.”