The FDA today imposed stricter regulations on certain radiological medical image analyzers, reclassifying them from Class III to Class II. Affected products include computer-assisted detection (CADe) devices for breast cancer mammography, breast-lesion ultrasound, and lung-nodule and dental-caries radiography, the agency said. It defines these devices as those intended to identify, mark, highlight, or in any […]
Philips issues urgent field safety notice for CombiDiagnost R90
Updated with a clarification from Philips. Royal Philips (NYSE:PHG) issued an urgent field safety notice to warn users of an issue with its CombiDiagnost R90 GCF fluoroscopy system. The imaging device used in radiography has shown an error issue when the table-tilting features are used. When using the “Table Up/Down” button on the device, Error 80, […]
Proton therapy lowers risk of side effects for cancer patients, study says
Findings from a new study claim that proton therapy leads to a significantly lower risk of side effects severe enough to lead to unplanned hospitalizations for cancer patients when compared to traditional radiation. Although cure rates between the proton therapy and radiation groups remain almost identical, the study conducted at the Perelman School of Medicine […]
Could an algorithm improve breast cancer treatment?
A study from researchers at Penn Medicine revealed that MRI and an algorithm-based field of medicine called radiomics could help characterize the heterogeneity of cancer cells in a tumor and allow for better understanding of the causes and progression of individual diseases. The study, published in Clinical Cancer Research, examines radiomics, which uses algorithms to extract […]
ControlRad adds five people to leadership team
ControlRad announced today that it made several additions to its leadership team, naming a new chief financial officer, VP of U.S. operations, VP of marketing and two new VPs of sales. The Atlanta-based company named Peter Pizzo as its new CFO. Pizzo has more than 25 years of experience in senior financial roles, having previously […]
Elekta wins FDA approval for diffusion-weighted images
Elekta (STO:EKTA B) today announced that it received FDA 510(k) premarket notification for its diffusion-weighted MR images from the Elekta Unity. The clearance allows the images to be interpreted by a trained physician. With the new FDA clearance, the system can be used for the biologic assessment of tumor response during therapy. Diffusion-weighted MR images (DWI) […]
Varian Medical spending extra on Endocare and Alicon purchase
Radiation oncology treatments and software maker Varian Medical Systems (NYSE:VAR) announced today that it updated its previously reported GAAP preliminary financial results for the fourth quarter and fiscal 2019. Earlier this week, the company uncovered new information and determined that the financial performance of its recently acquired Endocare and Alicon business was better than previously understood […]
Accuray shares drop as bottom line, revenues slide
Accuray (NSDQ:ARAY) shares are down today after the company reported decreased sales and profits in the first quarter of fiscal 2020. The Sunnyvale, Calif.-based radiotherapy device maker posted losses of -$9.4 million, or -11¢ per share, on sales of $89.6 million for the three months ended Sept. 30, for a bottom-line slide of -13% on a […]
Varian gets a jolt from meet-and-beat fiscal numbers, 202 forecast
Varian Medical (NYSE:VAR) got a jolt today from its fiscal fourth-quarter and full-year results, which met the consensus earnings forecast and topped Wall Street’s expectations for sales, and added a pair of names to its senior leadership roster. Palo Alto, Calif.-based radiotherapy device maker posted profits of $89.3 million, or 97¢ per share, on sales of […]
Shine Medical Technologies debuts therapeutics division
Medical isotopes maker Shine Medical Technologies last week created a division to make therapeutic products, saying it plans to first focus on a cancer treatment. The Janesville, Wis.-based company said its Shine Therapeutics business will begin with the development and commercialization of lutetium-177, an isotope that can be combined with a disease-targeting molecule, for treating […]
Isotope maker Shine Medical raises $50m from Oaktree Capital
Shine Medical Technologies said this week that it closed a $50 million financing round from Oaktree Capital Management for the construction of a medical isotope production facility and commercialization of its products. The Janesville, Wis.-based company expects construction on the plant to be completed in 2021, with commercial-scale isotope production slated to begin the following […]
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