Concord, CA – Prowess Inc., a leading provider of innovative medical device solutions, is pleased to announce the successful relocation to its new state-of-the-art facility and the completion of a comprehensive ISO 13485 audit with no major or minor findings. This significant milestone underscores the company’s continued commitment to quality and operational excellence.

The new facility, located at 5129 Commercial Cir. Concord, CA 94520, is designed to enhance operational efficiency, support future growth, and foster innovation in the development of cutting-edge medical technologies. With expanded production capabilities and upgraded infrastructure, Prowess is better positioned to meet the evolving needs of its customers and industry partners.

“The successful completion of the ISO 13485 audit at our new location demonstrates our unwavering focus on maintaining the highest quality standards throughout our operations,” said Sophia Brown, Regulatory Affairs Manager at Prowess Inc. “This achievement reflects the hard work and dedication of our entire team, and we are excited about the opportunities this new facility brings.”

ISO 13485 certification is a globally recognized standard for quality management systems in the medical device industry. The audit process involves rigorous assessments of a company’s processes, documentation, and adherence to regulatory requirements, ensuring the consistent delivery of safe and effective products.

The relocation to the new facility was completed on time, with minimal disruption to ongoing operations. The facility features modernized production areas, dedicated R&D spaces, and enhanced logistics capabilities, enabling Prowess to better serve its growing customer base.

Looking ahead, Prowess remains committed to continuous improvement and excellence in quality management. The company plans to leverage the new facility to accelerate product development, expand its portfolio, and strengthen partnerships across the medical device industry.

For more information about Prowess Inc. and its products, please visit www.prowess.com or call 925-356-0360.

Concord, CA – Prowess is proud to announce that it has received official registration approval from Colombia’s Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA). This significant achievement marks a milestone in the company’s commitment to providing high-quality products to the international market.

The registration, valid for a period of ten (10) years, allows the distribution and commercialization of Panther TPS in Colombia. The product has undergone a comprehensive verification process by INVIMA, ensuring compliance with national health and safety regulations.

“We are honored to receive this certification, which reinforces our dedication to delivering safe and effective products/services to customers in Colombia,” said Rick Smith, Director of Sales and Marketing. “This milestone opens up new opportunities for us to expand our presence in Latin America and continue offering solutions that meet the highest standards.”

Prowess looks forward to serving the Colombian market and contributing to the advancement of radiation oncology solutions in the region.

For more information or to schedule a product demonstration, please visit www.prowess.com or contact our support team at (925) 356-0360.

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

Concord, CA – Prowess Inc., a leading provider of advanced medical technology solutions, is proud to announce that its Panther OIS (Oncology Information System) has received clearance from the U.S. Food and Drug Administration (FDA) under Section 510(k) of the Federal Food, Drug, and Cosmetic Act. The Panther OIS has been cleared as a Class II medical device under regulation number 21 CFR 892.5050, designated for use in medical charged-particle radiation therapy systems.

The FDA’s substantial equivalence determination authorizes the Panther OIS to be marketed and used within the general controls provisions of the Act, ensuring compliance with critical regulatory requirements such as device registration, listing, and good manufacturing practices. This clearance signifies a major milestone in Prowess’ ongoing commitment to enhancing oncology care through innovative and reliable solutions.

The Panther OIS is designed to streamline clinical workflows and improve the delivery of oncology treatment, offering healthcare providers enhanced tools for patient management and radiation therapy coordination.

“We are thrilled to receive FDA clearance for Panther OIS, marking a pivotal step forward in our mission to empower oncology professionals with cutting-edge technology,” said Rachel Scarano, Regulatory Affairs Manager. “This clearance underscores our dedication to delivering high-quality solutions that meet stringent regulatory standards and improve patient outcomes.”

For more information about the Panther OIS or Prowess’ oncology solutions, please visit  www.prowess.com or contact our support team at (925) 356-0360.

Concord, CA – Prowess, Inc., a leading provider of advanced medical technology solutions, is proud to announce that its Panther Stereotactic Radiation Therapy System has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) under regulation number 21 CFR 892.5050. This clearance confirms that Panther Stereotactic is substantially equivalent to legally marketed predicate devices and can now be marketed in the United States.

The Panther Stereotactic system, classified as a Class II medical device, offers precise medical charged-particle radiation therapy planning. It is designed to plan for targeted radiation treatment, ensuring accuracy and minimizing exposure to surrounding healthy tissues.

The FDA’s decision, following a comprehensive review of the submission (K193459), highlights the innovative design and reliability of the Panther Stereotactic system. This clearance underscores Prowess, Inc.’s commitment to advancing medical technology and improving outcomes for patients undergoing radiation therapy.

“We are thrilled to receive this important regulatory milestone for Panther Stereotactic,” said John Nguyen, CEO at Prowess, Inc. “This clearance allows us to bring cutting-edge radiation therapy solutions to healthcare providers, enhancing their ability to treat complex cases with greater precision and confidence.”