Allotrope Medical this week said it received FDA clearance for its StimSite. The device is designed to help surgeons locate and identify ureters during surgery. StimSite provides electrical stimulation to ureter smooth muscle tissue by testing ureter smooth muscle excitability. It can be used by OB/GYNs, general and colorectal surgeons with existing surgical instruments. “Whether […]
Imaging
How has COVID-19 changed healthcare’s appetite for buying medical devices
This week’s DeviceTalks Weekly Podcast examines medtech’s readiness for the next COVID-19 surge. Hospitals are ready, but their appetite for expensive medical devices has changed, forcing medtech companies to change how they sell or lose out entirely. Justin Cassidy and Henry Soch of Vizient reveal why hospital executives are forced to divert funds away from […]
Lantheus gains FDA clearance for bone scan AI
Lantheus Holdings (NSDQ:LNTH) announced today that it received FDA 510(k) clearance for its automated bone scan index (aBSI). The North Billerica, Mass.-based parent company of Lanthus Medical Imaging, Progenics Pharmaceuticals and Exini Diagnostics said in a news release that the clearance is for the artificial intelligence-enabled aBSI product for use on GE Healthcare’s Xeleris platform. In […]
Hologic launches hysteroscopy system
Hologic (NSDQ:HOLX) announced today that it launched the Omni suite for optimizing diagnostic and operative hysteroscopy. Marlborough, Mass.-based Hologic’s newly launched suite includes the Omni 30° hysteroscope along with Omni 4K video technology to complement its existing portfolio of GYN surgical solutions, according to a news release. The new Omni hysteroscope offers diagnostic and operative versatility […]
Accuray ticks up on Street-beating Q1
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 […]
Abbott launches next-gen 3D cardiac mapping platform in Europe, Australia
Abbott (NYSE:ABT) announced today that it received CE Mark and Australian approval for its new EnSite X EP system. EnSite X EP is touted as the only system that allows for navigation of the cardiac anatomy in two different ways through the same lone platform. The new cardiac mapping platform builds upon Abbott’s electrophysiology portfolio with […]
DTW Podcast: Hear the future of AI, 3D, and Dx from Edwards, Stryker, Evercore, Checkable
In this week’s episode of DeviceTalks Weekly we review the Medical Design & Outsourcing’s Women in Medtech issue — bringing you insights through interviews with Katie Syzman, corporate VP and the GM of critical care at Edwards Lifesciences, Naomi Murray, Stryker’s director of advanced operations, and Patty Post, CEO of Startup Checkable Medical. Szyman […]
Siemens’ X-ray system gains FDA clearance
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 […]
DTW: Philips’ Imaged Guided leader Landon shares global giant’s plans for minimally invasive devices
In this week’s DeviceTalks Weekly podcast, we visit with Chris Landon, senior vice president and business leader of image guided therapy devices at Philips about that company’s plans to build a medtech powerhouse. In this conversation we’ll learn: Why Landon left Medtronic Where Philips fits into medtech’s future How Philips hopes to expand Will Philips […]
FDA clears AI for Vida Diagnostics lung imagaging analysis software
Vida Diagnostics announced that it received FDA 510(k) clearance for enhancements to its AI-based LungPrint solution. Enhancements involved in the clearance include automated deep learning-based lung and lobe segmentation algorithms, which the company said further validates its products’ quality and clinical efficacy, according to a news release. LungPrint’s algorithms allow the company to improve its […]
FDA clears Aidoc triage of incidental pulmonary embolism
Aidoc announced today that it received FDA clearance for the commercial use of its triaging algorithms for pulmonary embolism. New York-based Aidoc’s triaging and notification algorithms designed to flag and communicate incidental pulmonary embolism offers increased efficiency in prioritizing incidental critical conditions through artificial intelligence (AI), according to a news release. The technology offers an […]