Accuray (NSDQ:ARAY) announced that it promoted executive Suzanne Winter to president, effective as of July 1, 2021. Winter, who previously served as Sunnyvale, Calif.-based Accuray’s chief commercial officer and SVP of R&D & medical & scientific affairs, will continue to report to CEO Joshua Levine. “Suzanne has had a significant impact on Accuray’s product portfolio […]
Imaging
Latest iCad 3D mammography AI gains CE mark
iCad (NSDQ:ICAD) today announced that the third version of its ProFound AI for digital breast tomosynthesis (DBT) has won CE mark approval. Compared with previous software versions, the latest generation of ProFound AI offers up to a 10% improvement in specificity performance while maintaining a high sensitivity level, and approximately 40% faster processing on the new […]
Unraveling aducanumab’s impact remains a challenge
The FDA’s conditional approval of Biogen’s (NSDQ:BIIB) and Eisai’s (OTCMKTS:ESALY) Alzheimer’s drug aducanumab (Aduhelm) may have been controversial, but the decision will likely have a significant financial impact. There are 6 million people with Alzheimer’s in the U.S. alone, according to Alzheimer’s Association estimates. Approximately half of those patients have mild symptoms, which is the group most likely […]
Avicenna.AI’s triage system get regulatory nods
Avicenna.AI announced today that it received FDA 510(k) clearance and CE mark for its Cina Chest vascular condition triage system. Marseille, France-based Avicenna.AI designed Cina Chest to leverage deep learning algorithms to offer automatic detection and triage capabilities for both pulmonary embolism (PE) and aortic dissection (AD) from CT-scan imaging, according to a news release. […]
Butterfly Network wins Canadian approval for next-gen handheld ultrasound
Butterfly Network (NYSE: BFLY) announced today that Canada has approved its second-generation iQ+. Butterfly Network touts the iQ+ features what the company describes as the world’s only Ultrasound-on-Chip technology, boasting hardware and software advances to improve usability and care delivery. “We are excited that the Butterfly iQ+ will now be available for purchase by Canadian […]
Lucida Medical gains CE mark for cancer-detection software
Lucida Medical announced today that it received CE mark approval for its machine learning-based prostate cancer detection software. Cambridge, UK-based Lucida’s Prostate Intelligence (Pi) software offers a way for radiologists to assess and report MRI imaging studies and support the decision of whether or not to perform a biopsy, while also accurately targeting biopsies where […]
Ibex AI-enabled breast cancer diagnostic lands CE mark
Ibex Medical Analytics announced today that it received CE mark approval for its Galen AI-based breast cancer diagnostic platform. Tel Aviv, Israel–based Ibex’s Galen platform uses AI and machine learning technology based on hundreds of thousands of image samples scanned from biopsy slides through digital pathology, according to a news release. Galen previously won CE […]
DTW Podcast: How AtriCure built a big business in Afib; A deep look into Abbott’s new Coronary imaging platform
In this week’s episode of the DeviceTalks Weekly Podcast, Dr. Nick West, CMO & divisional VP of global medical affairs at Abbott’s vascular business, discusses the European launch of the company’s new coronary imaging platform. Dr. West explains how the AI-powered platform works and the benefits it offers for decision-making during coronary stenting procedures. He […]
Neoscan debuts MRI scanner for babies
Neoscan Solutions last week unveiled a small, light MRI scanner designed to keep journeys short and to scan sick babies in their sleep. Grosshansdorf, Germany-based Neoscan’s lightweight scanner deviates from the current MRI scanners, which weigh around eight tons and need to be located on floors that can bear such weight, while also requiring more […]
Google set to launch its first medical device
Google has unveiled an artificial intelligence-powered tool designed to identify dermatologic issues. In a news release, the technology giant cited billions of yearly Google searches related skin, nail and hair issues as a reason for developing the technology. The company plans to launch the web-based application as a pilot later on this year. Once they […]
This imaging device could be a breast cancer treatment breakthrough
OncoRes Medical’s system may detect cancer cells on a microscopic scale during a lumpectomy, potentially averting the need for a second breast cancer surgery. Having breast surgery to remove a cancerous lump is traumatic enough. Learning that you’ll need another operation to remove cancer cells that the surgeon couldn’t detect the first time only adds […]