Ezra today announced it received FDA 510(k) clearance for its Ezra Flash AI platform that enhances the quality of MR images. New York-based Ezra designed Ezra Flash to reduce the time needed to complete a high-quality scan with the hopes of reducing MRI costs. The company plans to use the technology to launch what it […]
Radiosurgery/Radiation therapy
Data supports Biosense Webster RF ablation for treating AFib
Johnson & Johnson MedTech’s Biosense Webster today announced data from a study of its QDOT Micro catheter for treating AFib. JACC: Clinical Electrophysiology published data from the Q-FFICIENCY study evaluating QDOT Micro’s safety and 12-month effectiveness. The study observed the use of the catheter in paroxysmal AFib ablation using a combination of high-power and conventional modes. […]
X-ray tech developer Oxos raises $23M in Series A funding round
Oxos Medical announced today that it raised $23 million in a Series A financing round led by Parkway Venture Capital and Intel Capital. Atlanta-based Oxos said the round brings its total funding to $45 million. It plans to use the funds to accelerate product innovation and expand availability globally. The company develops what it calls […]
Kardium treats first patient in pulsed-field ablation study
Kardium announced today that it successfully treated the first patients in the PULSAR clinical study for its Globe PF pulsed-field ablation (PFA) system. Vancouver, British Columbia-based Kardium recently received FDA investigational device exemption (IDE) to conduct the study. The international, multicenter PULSAR study evaluates the safety and effectiveness of Globe PF for the treatment of […]
Medtronic wins CE mark for Affera ablation system
Medtronic (NYSE:MDT) announced today that it received CE mark approval for its Affera mapping and ablation system. The Affera system includes the Sphere-9 catheter and Affera Prism-1 mapping software. Together, the system integrates Sphere-9 pulsed-field ablation (PFA), radiofrequency (RF) and high-density (HD) mapping. It maps and ablates atrial arrhythmias — including AFib — and provides […]
Elekta forms radiotherapy partnership with Sinopharm in China
Elekta announced today that it entered into a joint venture with Sinopharm to increase the adoption of radiation therapy in China. The initiative aims to bring radiation therapy to what’s considered lower-tier cities. These cities comprise approximately 70% of China’s population, according to a news release. Elekta develops precision radiation therapy to treat cancer. The […]
Biosense Webster marks first cases with dual energy ablation tech
Biosense Webster today announced the first cases with its investigational Thermocool SmartTouch SF dual energy catheter for treating AFib. The system enables doctors performing an ablation to toggle between two types of energy: pulsed-field and radiofrequency. It appears to be the Johnson & Johnson MedTech subsidiary’s answer to the dual energy ablation tech coming out […]
Candela launches radiofrequency microneedle system
Candela announced today that it launched its new Profound Matrix system for radiofrequency-delivered skin treatments. Marlborough, Massachusetts-based Candela designed the Profound Matrix system to correct, maintain and restore skin. The multi-application system utilizes the Sublime, Sublative RF and new Matrix Pro applicators. Sublime and Sublative RF deliver bipolar radiofrequency (RF) treatments that improve the appearance […]
Varian wins U.S., European clearance for radiotherapy systems
Siemens Healthineers‘ Varian announced today that it received FDA 510(k) clearance and CE mark for its Halcyon and Ethos systems. Both radiotherapy systems feature Varian’s HyperSight imaging solution. HyperSight enables clinicians to capture high-quality images of patients during their daily radiation treatments. The images help in the daily localization of patient tumors and their uses […]
FDA clears biology-guided radiotherapy from RefleXion
RefleXion Medical announced today that the FDA cleared its Scintix biology-guided radiotherapy treatment for cancer. Hayward, California-based RefleXion designed the Scintix platform for use in treating both early- and late-stage cancers. The company said Scintix is the first and only radiotherapy that allows each cancer’s unique biology to autonomously determine how much radiation to deliver. […]
Accuray stock rises on Street-beating Q2
Accuray (Nasdaq:ARAY) shares rose this morning on second-quarter results that topped the consensus forecast. ARAY shares ticked up 12.1% at $2.75 apiece. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — rose 14.4%. The Sunnyvale, California–based radiation oncology company posted losses of $1.9 million. That amounts to losses […]