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Radiosurgery/Radiation therapy

ControlRad gains clearance for imaging tech to sell to Boston Sci

March 4, 2021 By Sean Whooley Leave a Comment

ControlRad announced today that it received FDA 510(k) clearance to market its ControlRad Select radiation reduction technology. Atlanta-based ControlRad’s technology uses proprietary semi-transparent filters with a user-interface tablet and imaging processing algorithms that are retrofitted onto customers’ existing Siemens Artis zee interventional imaging systems, according to a news release. ControlRad, ahead of its commercialization efforts […]

Filed Under: 510(k), Business/Financial News, Featured, Food & Drug Administration (FDA), Imaging, Radiosurgery/Radiation therapy, Regulatory/Compliance Tagged With: Boston Scientific, ControlRad

Cyber vulnerability discovered in GE Healthcare radiological devices

December 9, 2020 By Sean Whooley

CyberMDX announced that it uncovered a cyber vulnerability across a range of popular devices made by GE Healthcare (NYSE:GE). The U.S. Dept. of Homeland Security’s Cybersecurity and Infrastructure Security Agency (CISA) disclosed the vulnerability yesterday after CyberMDX discovered that it could affect dozens of radiological devices by allowing an attacker to gain access to sensitive data, […]

Filed Under: Big Data, Electronic Medical Records (EMR), Featured, Health Technology, Imaging, Radiosurgery/Radiation therapy, Software / IT Tagged With: cybermdx, GE Healthcare

Accuray ticks up on Street-beating Q1

November 5, 2020 By Sean Whooley

Accuray (NSDQ:ARAY) shares ticked up today on first-quarter results that came in ahead of the consensus forecast. The Sunnyvale, Calif.-based radiotherapy device maker posted profits of $402,000, breaking even on a per-share basis, on sales of $85.3 million for the three months ended Sept. 30, 2020, for a bottom-line gain from losses of more than -$9.3 […]

Filed Under: Business/Financial News, Imaging, MassDevice Earnings Roundup, Radiosurgery/Radiation therapy, Surgical, Wall Street Beat Tagged With: Accuray Inc.

Siemens’ X-ray system gains FDA clearance

October 26, 2020 By Nancy Crotti

Siemens Healthineers (ETR: SHL) today announced FDA clearance of the YSIO X.pree, a ceiling-mounted radiography system. YSIO X.pree comes with the MyExam Companion intelligent user interface, a new 3D camera for patient positioning and advanced collimation, and a new smart image processing engine. The MyExam Companion user interface provides proactive guidance to help technologists of any skill […]

Filed Under: 510(k), Business/Financial News, Featured, Food & Drug Administration (FDA), Imaging, Radiosurgery/Radiation therapy, Regulatory/Compliance Tagged With: FDA, Siemens Healthineers

Aidoc raises $20M more in Series B funding

September 16, 2020 By Sean Whooley

Medical imaging tech developer Aidoc announced today that it raised an additional $20 million as part of a Series B extension round. New York-based Aidoc said in a news release that the announcement comes on the back of tripled revenues since the beginning of 2020, while the latest funding brings its total financing to $60 […]

Filed Under: Business/Financial News, Funding Roundup, Imaging, Radiosurgery/Radiation therapy Tagged With: aidoc

ControlRad wins FDA nod for radiation reduction technology

September 15, 2020 By Sean Whooley

ControlRad announced today that it received FDA 510(k) clearance for the use of its ControlRad Trace on OEC 9900 Mobile C-arms. Atlanta-based Controlrad’s Trace system is designed for reducing radiation in fluoroscopically guided procedures. According to a news release, the ControlRad Trace can be retrofitted onto existing mobile C-arms with its proprietary semi-transparent filter, tablet […]

Filed Under: 510(k), Business/Financial News, Food & Drug Administration (FDA), Funding Roundup, Imaging, Radiosurgery/Radiation therapy, Regulatory/Compliance

Accuray dips on mixed bag Q4

August 14, 2020 By Sean Whooley

Accuray (NSDQ:ARAY) shares took a hit today on fourth-quarter results that were mixed compared to the consensus forecast. The Sunnyvale, Calif.-based radiotherapy device maker posted losses of -$823,000, or -1¢ per share, on sales of $94.98 million for the three months ended June 30, 2020, for a 41.2% bottom-line gain on a sales decline of -19.1%. […]

Filed Under: Business/Financial News, Imaging, MassDevice Earnings Roundup, Radiosurgery/Radiation therapy, Surgical, Wall Street Beat Tagged With: Accuray Inc.

Siemens Healthineers wins FDA clearance for in-bed CT head scans

August 5, 2020 By Sean Whooley

Siemens Healthineers (ETR:SHL) announced today that the FDA cleared its Somatom On.site mobile head computed tomography (CT) scanner. Malvern, Pa.-based Siemens Healthineers’ Somatom On.site scanner enables critically ill patients to receive CT head imaging in the intensive care unit (ICU) while remaining in bed, eliminating costly transports to the radiology department, according to a news […]

Filed Under: Food & Drug Administration (FDA), Imaging, Radiosurgery/Radiation therapy, Regulatory/Compliance Tagged With: FDA, Siemens Healthineers

Boston Scientific touts SpaceOAR meta-analysis results

June 18, 2020 By Sean Whooley

Boston Scientific (NYSE:BSX) announced that published results from an analysis of its SpaceOAR hydrogel spacer revealed safe prostate-rectum separation. Marlborough, Mass.-based Boston Scientific has developed the SpaceOAR since its $600 million acquisition of Augmenix in September 2018. The absorbable polyethylene glycol hydrogel spacer won CE Mark approval in the European Union in 2010 and 510(k) clearance from the […]

Filed Under: Clinical Trials, Featured, Men's Health, Oncology, Radiosurgery/Radiation therapy Tagged With: Augmenix Inc., Boston Scientific

Accuray launches CyberKnife S7 system

June 17, 2020 By Sean Whooley

Accuray (NSDQ:ARAY) announced today that it launched its CyberKnife S7 system for stereotactic radiosurgery (SRS) and stereotactic body radiation therapy (SBRT). Using real-time artificial intelligence-driven motion tracking and synchronization, CyberKnife S7 offers treatments for SRS and SBRT in as little as 15 minutes, according to a news release. The system’s AI adapts radiation delivery to patient […]

Filed Under: Business/Financial News, Imaging, Oncology, Radiosurgery/Radiation therapy, Robotics, Software / IT Tagged With: Accuray Inc., AI, artificial intelligence

RefleXion, Merck team up on late-stage cancer study

May 28, 2020 By Sean Whooley

RefleXion announced today that it entered into a clinical collaboration with Merck to evaluate Merck’s (NYSE:MRK) Keytruda anti-PD-1 therapy in clinical trials. Hayward, Calif.-based therapeutic oncology company RefleXion is joining forces with Merck to evaluate Keytruda’s safety and efficacy in combination with RefleXion’s biology-guided radiotherapy (BgRT) in multiple late-stage cancers, including non-small cell lung cancer, in […]

Filed Under: Business/Financial News, Clinical Trials, Featured, Imaging, Oncology, Radiosurgery/Radiation therapy Tagged With: Merck, RefleXion Medical

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