News | Proton Therapy | October 07, 2019

ProTom Receives U.S. FDA 510(k) Clearance for Radiance 330 Single Room Proton Therapy System

ProTom International received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Radiance 330 proton therapy system

ProTom International received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Radiance 330 proton therapy system installed at Massachusetts General Hospital (MGH) in Boston, Mass.

The Radiance 330 proton therapy system at MGH is a compact, single room system equipped with an advanced pencil beam scanning system and integrated imaging and control system. The Radiance 330 compact synchrotron can be installed within an interior accelerator vault space of 20′ x 30′ and requires up to 40 percent less radiation shielding.

By using the advanced pencil beam scanning technology, modular designed treatment system and the compact synchrotron particle accelerator, Radiance 330 is a smaller, lighter and cleaner system.

"We are delighted to have received the marketing authorization for the Radiance 330 proton therapy system installed at MGH. The receipt of 510(k) clearance is the final culmination of a thorough and rigorous FDA review of the safety and effectiveness of our compact proton therapy solution," said Steve Spotts, Chief Executive Officer and co-founder of ProTom International. "This achievement accelerates ProTom's single and relentless mission to place this highly sophisticated and targeted cancer-fighting tool within reach of many more physicians. Our team couldn't be more proud of reaching this milestone and will continue our work to advance the delivery of proton therapy while driving down the cost of this much-needed technology."

For more information: https://www.protominternational.com

Related Content

Low four-year rates of gastrointestinal (13.6 percent) and urologic issues (7.6 percent) suggest hypofractionated proton therapy as an alternative to traditional radiotherapy to reduce toxicity.

Low four-year rates of gastrointestinal (13.6 percent) and urologic issues (7.6 percent) suggest hypofractionated proton therapy as an alternative to traditional radiotherapy to reduce toxicity.

Feature | Prostate Cancer | October 16, 2019 | By Jeff Zagoudis
Radiation therapy is an important tool in the clinician’s armamentarium for treatment of localized, early-stage prost
Videos | Radiation Oncology | October 11, 2019
Lorraine Drapek, DNP, nurse practitioner, radiation oncology, GI service,...
Patient Treatments With ViewRay's MRIdian Linac Begin in New England
News | Image Guided Radiation Therapy (IGRT) | October 08, 2019
ViewRay Inc. announced today that patient treatments are scheduled to begin in Boston with ViewRay's MRIdian Linac...
Videos | Prostate Cancer | September 30, 2019
Bill Hartsell, M.D., medical director of the Northwestern Medicine Proton Center in Warrenville, Ill., discusses the
AI Accurately Predicts Radiotherapy Side Effects for Head and Neck Cancer Patients
News | Artificial Intelligence | September 26, 2019
For the first time, a sophisticated computer model has been shown to accurately predict two of the most challenging...
Partial and Whole-Breast Radiotherapy After Lumpectomy Provide Equally Satisfying Cosmetic Results
News | Radiation Therapy | September 25, 2019
Whole breast radiation and partial breast radiation following a lumpectomy yield similar cosmetic outcomes for women...
Hippocampal Avoidance Using IMRT Now Recommended as Standard of Care for Brain Metastases
News | Radiation Therapy | September 24, 2019
Patients with brain metastases who received whole-brain radiotherapy that avoided memory-specific hippocampal neural...