December 15, 2023
Concord, CA – Prowess Inc., a leader in innovative radiation therapy solutions, is pleased to announce the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its latest version of the Panther Treatment Planning System (TPS), version 5.9. This clearance marks a significant milestone in Prowess’ commitment to advancing precision radiation therapy for cancer patients worldwide.
The Panther TPS 5.9 offers a cutting-edge, fully integrated platform for radiation therapy planning, supporting highly complex treatment modalities including Intensity-Modulated Radiation Therapy (IMRT), Arc Therapy, and Stereotactic Radiotherapy. Designed for use by radiation oncologists, physicists, and dosimetrists, the system facilitates optimal treatment planning through precise dose calculations and advanced imaging integration.
Key Features of Panther TPS 5.9:
Comprehensive Treatment Modules: The software includes several advanced modules such as:
IMRT Module: Enables precise planning for intensity-modulated radiation therapy using external photon beams.
ProArc Module: Facilitates the creation of treatment plans for intensity-modulated arc radiation therapy.
Stereotactic Module: Supports highly precise and targeted radiation therapy, critical for advanced cancer cases.
Expanded Platform Compatibility: Now supporting Windows Server alongside Windows 10, ensuring greater flexibility for healthcare institutions.
Validated Performance and Safety: Panther TPS 5.9 underwent extensive in-house verification and validation testing, demonstrating its equivalence in safety and effectiveness compared to its predicate device, Panther Stereotactic.
“The FDA clearance of Panther TPS 5.9 underscores our dedication to improving patient outcomes through technological innovation,” said Rachel Scarano, Regulatory Affairs Manager at Prowess Inc. “This version is built to meet the demanding requirements of modern radiation therapy, enabling clinicians to deliver safe, effective, and personalized treatments.”
Commitment to Quality and Safety
Prowess Inc. maintains stringent quality assurance processes in compliance with FDA regulations and ISO 13485 standards. The company has conducted comprehensive risk assessments and implemented advanced mitigation measures to ensure the safety and efficacy of Panther TPS 5.9.
About Prowess Inc.
Prowess Inc. is a medical technology company specializing in radiation therapy software for cancer treatment. Founded on a mission to enhance precision medicine, Prowess offers innovative solutions that empower healthcare providers to improve cancer care.
For more information, please visit www.prowess.com or contact:
Media Contact
Rachel Scarano
Regulatory Affairs Manager
Prowess Inc.
Tel: (925) 356-0360
Email: Rachel.scarano@prowess.com