1. India approves Accuray’s Radixact X9 radiation therapy device
Accuray announced in a June 21 press release that it has received an Atomic Energy Regulatory Board Type Approval in India for its Radixact X9 System. The approval allows the company to sell the TomoTherapy platform while allowing hospitals throughout India to import the system. The Radixact and TomoTherapy Systems are radiation therapy devices that can deliver treatment from both clinician-specified bean angles and by continuous delivery of radiation from 360º around the patient. The Radixact System can be used for a number of cases including large tumors or multiple tumors throughout the body, standard radiation therapy indications like breast, lung, prostate and head and neck cancers, as well as complex treatments like total marrow irradiation and whole-brain with simultaneous boosts to multiple metastases.
2. FDA clears Tenon Medical’s Catamaran sacroiliac fusion device
Tenon Medical has received FDA 510(k) clearance for its Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System), according to a June 20 press release. The CAT SJI Fixation System is designed for sacroiliac joint fusion for conditions such as sacroiliac joint disruptions and degenerative sacroiliitis. Tenon Medical’s system allows surgeons to use a navigated procedure or fluoroscopic imaging for flexibility in access and visibility. It is designed to allow for bone graft materials to be loaded and delivers to the SIJ before and after implant to promote SIJ fusion.
3. BTG inks deal with pulmonary embolism consortium
BTG announced in a June 21 press release that it has forged a strategic partnership with PERT Consortium to advance research of pulmonary embolism treatment while promoting the implementation fo PERT programs across the U.S. Through the partnership, BTG hopes to improve patient care and reduce in-hospital mortality that is associated with pulmonary embolism.