Provision Healthcare krijgt FDA-vergunning voor protonentherapiesysteem SC360 van ProNova
KNOXVILLE, Tennessee–(BUSINESS WIRE)– De dochteronderneming van Provision Healthcare voor onderzoek, ontwikkeling en productie, ProNova Solutions, heeft een 510(k)-vergunning van FDA gekregen voor zijn protonentherapiesysteem SC360. De goedkeuring komt slechts vier jaar nadat het onderzoek naar dit systeem is begonnen. SC360 is het eerste en enige protonentherapiesysteem met een potloodstraal en bereik van 360 graden. Daardoor is dit systeem in staat patiënten vanuit alle hoeken te behandelen, wat de klinische workflow efficiënter maakt, de accuratesse van therapieën verhoogt en het comfort van patiënten vergroot.
Provision Healthcare heeft ProNova in 2012 gelanceerd om een technologisch geavanceerdere protonentherapie te ontwikkelen. ProNova benut de ervaring van haar oprichters in de ontwikkeling en internationale vermarkting van PET- en PET/CT-technologie voor de bouw van compacte protonentherapiesystemen met gepatenteerde supergeleidende technologieën, die daardoor meer waard zijn dan concurrerende systemen.
Provision Healthcare Receives FDA Clearance of the ProNova SC360 Proton Therapy System |
|||||
|
KNOXVILLE, Tenn.–(BUSINESS WIRE)– Provision Healthcare’s research, development and manufacturing subsidiary, ProNova Solutions, has received FDA 510(k) clearance for its SC360 proton therapy system only four years after commencing research and development. This is the first and only compact 360 degree pencil beam scanning proton therapy system capable of treating patients at all angles without moving the patient, enabling the most efficient clinical workflows, improved accuracy of treatment, and patient comfort. The first ProNova system is expected to be used for patient treatment at the Provision CARES Proton Therapy Center in Knoxville, Tennessee next year. Provision Healthcare launched ProNova in 2012 to develop a more technologically advanced proton therapy treatment system. Leveraging its founders’ experience in the development and global commercialization of PET and PET/CT technology, ProNova utilizes proprietary, superconducting technology to build compact proton therapy systems with greater value than competing systems. The ProNova SC360 is the only proton therapy system developed in a clinical setting, benefitting from continuous input from physicians, medical physicists, and therapists during the entire course of design and development. The system includes state-of-the-art features such as pencil beam scanning and advanced imaging with cone-beam CT, all in a compact design. “Achieving this milestone is an enormous accomplishment for our company and will allow us to offer the most advanced technology without compromising features for proton therapy treatment through systems that are smaller, lighter and easier to install while increasing capabilities compared to our competitors,” said Joe Matteo, President of ProNova Solutions. “The ProNova SC360 will not only improve proton therapy treatment, but due to its lower cost, will make proton therapy more accessible to patients worldwide.” “Provision Healthcare provides innovative healthcare solutions that CARES for the patient as we offer the ProNova system in developing proton therapy centers around the world,” saidTerry Douglass, Executive Chairman of Provision Healthcare. Provision Solutions is the exclusive distributor of the ProNova system and has multiple agreements for development of proton therapy centers utilizing the ProNova Solutions systems in the United States, Europe and Asia. About Provision Healthcare, LLC About ProNova Solutions, LLC View source version on businesswire.com: http://www.businesswire.com/news/home/20161208005859/en/ Contacts Provision Healthcare |
|||||