RefleXion Medical announced today that the first patient completed treatment with Scintix biology-guided radiotherapy on its X1 machine. Scintix treats early- and late-stage cancers using the individual biology of each tumor to drive its own treatment. It allows each cancer’s unique biology to autonomously determine how much radiation to deliver. This occurs on a second-by-second […]
Radiosurgery/Radiation therapy
Philips warns on potential unintended radiation with imaging systems
Philips issued an urgent field safety notice in Europe regarding a potential issue with some of its imaging systems. The issue pertains to the wired and wireless foot switches used with the Philips Allura Xper, Allura Centron, Azurion and the MultiDiagnost-Eleva systems. It could lead to unintended radiation, according to the notice filed in Europe […]
Accuray gets FDA nod for breast cancer treatment on Radixact system
Accuray (Nasdaq:ARAY) announced that the FDA granted 510(k) clearance to its VitalHold breast package on the Radixact system. The company also says it expects the treatment option to become available in Europe. VitalHold facilitates deep inspiration breath hold (DIBH) treatments. It uses the Radixact System’s fixed beam angle delivery mode (TomoDirect) and fully integrated, automated […]
FDA approves multiple AFib ablation devices from Biosense Webster
Johnson & Johnson’s Biosense Webster announced today that the FDA approved several products in its cardiac ablation portfolio for zero fluoroscopy workflow. Products that received approval include the ThermoCool SmartTouch SF catheter, the most commonly used ablation catheter for radiofrequency ablation. The portfolio’s approved products also include the standard ThermoCool SmartTouch and Carto Vizigo bi-directional […]
NeuroOne prices $5.25M public offering
NeuroOne Medical Technologies (Nasdaq:NMTC) announced today that it priced an underwritten registered public offering. Eden Prairie, Minnesota-based NeuroOne’s offering includes 5.25 million shares of common stock priced at $1 per share. All shares included in the offering will be sold by the company. NeuroOne also granted the underwriter a 30-day option to purchase up to […]
4-year data backs Relievant Medsystems’ Intracept ablation procedure
Relievant Medsystems announced four-year pooled data from two prospective clinical trials that support the use of its Intracept procedure. Intracept — a minimally invasive, FDA-cleared, same-day, outpatient procedure — treats chronic vertebrogenic low back pain. The procedure utilizes targeted radiofrequency energy to ablate the basivertebral nerve (BVN). This stops the nerve from transmitting pain signals […]
Relievant Medsystems unveils new tools for its ablation system
Relievant Medsystems announced today that it launched its next-generation access instruments for the Intracept procedure. Intracept — a minimally invasive, FDA-cleared, same-day, outpatient procedure — treats chronic vertebrogenic low back pain. It uses targeted radiofrequency energy to ablate the basivertebral nerve (BVN). This stops the nerve it from transmitting pain signals to the brain. The […]
GE HealthCare to unveil new PET/MRI imaging tech
GE HealthCare announced its plans to unveil its Signa PET/MR AIR technologies for enhancing imaging. The company intends to unveil the new technology at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2023 annual meeting. It said the platform showcases the integration of advanced AIR technologies with SIGNA, enhancing diagnostic precision. Signa also can simplify […]
FDA approves Metavention’s renal denervation for hypertension pivotal IDE study
Metavention announced today that the FDA granted approval to initiate an investigational device exemption (IDE) trial for its renal denervation system. Minneapolis-based Metavention designed its integrated radiofrequency (iRF) renal denervation system to treat hypertension. The company plans for its randomized, double-blinded, sham-controlled RADAR study to enroll up to 300 patients across 50 centers. This pivotal […]
Relievant Medsystems reports positive data for nerve ablation procedure
Relievant Medsystems announced today that three-year data from two clinical trials further validate its Intracept procedure. Intracept, a minimally invasive, FDA-cleared, same-day, outpatient procedure, treats chronic vertebrogenic low back pain. It uses targeted radiofrequency energy to ablate the basivertebral nerve (BVN), stopping it from transmitting pain signals to the brain. The procedure takes approximately one […]
NeuroOne submits RF ablation system for FDA 510(k) clearance
NeuroOne Medical Technologies (Nasdaq:NMTC) announced today that it submitted an FDA 510(k) application for its OneRF ablation system. This technology uses already-implanted sEEG electrodes to record brain activity and enable the ablation of nervous tissue. It connects to a proprietary radiofrequency (RF) generator. NeuroOne’s electrodes provide a similar function at the subsurface level of the […]