The FDA published a warning letter that it sent to Philips that outlines issues around imaging technology manufacturing practices. During an inspection of a manufacturing facility in Suzhou, China, the FDA determined that the devices are “adultered.” The inspection took place from Oct. 23, 2023, through Oct. 26, 2023. Philips received the letter outlining violations […]
Imaging
Exo adds AI-powered cardiac, lung apps to handheld ultrasound
Exo announced today that it launched its FDA-cleared cardiac and lung AI applications for the Iris handheld ultrasound device. The company now has FDA clearance for five different applications on Iris — cardiac, lung, bladder, hip and thyroid. It expects to double that number by 2025. Iris delivers high-performance medical imaging at a fraction of […]
Titan Medical progresses with Conavi merger
Titan Medical today provided a progress update regarding its planned merger with surgical guidance technology company Conavi Medical. The companies entered into a definitive amalgamation agreement to combine in an all-stock transaction last month. They aim to commercialize Conavi’s Novasight Hybrid system for guiding common minimally invasive coronary procedures. Conavi Medical designs, manufactures and markets imaging […]
GE HealthCare adds MIM Software to Elekta collaboration
GE HealthCare announced today that it expanded its relationship with Elekta with more collaboration on software for radiation oncology. Together, the companies aim to accelerate innovation in software to improve workflows, increase throughput and enhance user experience. They expect to enable greater precision in radiation therapy treatment with less time at the hospital for patients. […]
FDA clears new Zenition 30 mobile C-arm from Philips
Philips announced today that the FDA granted 510(k) clearance for its Zenition 30 mobile C-arm. Zenition 30 reduces the dependency on support personnel by giving surgeons greater flexibility, control and personalization of C-arm movement and user settings. This can help to alleviate staff shortages that limit patient access and increase waiting times. It could also […]
GE HealthCare launches new AI-enhanced ultrasound for women’s health
GE HealthCare announced today that it launched the Voluson Signature 20 and 18 ultrasound systems for women’s health imaging applications. Chicago-based GE HealthCare designed the systems to integrate AI, advanced tools and an ergonomic design. They speed exam time for clinicians while delivering a clearer picture of various conditions impacting women’s health. The latest systems […]
Noah Medical has positive robotic bronchoscopy data
Noah Medical today announced new field data detailing early experience using its Galaxy system for robotic-navigated bronchoscopy. Dr. D. Kyle Hogarth (University of Chicago Medical Center) and Dr. Amit Mahajan (Inova Fairfax Hospital) provided the field data. It represents the findings from 165 total patient procedures investigating 190 total lesions. Key findings include diagnostic yield […]
Medtronic unveils new AI for laparoscopic, robotic surgery tech
Medtronic today announced new AI capabilities to go with the launch of its Touch Surgery Live Stream digital offering. The medtech giant’s 14 new AI algorithms enhance its digital capabilities within post-operative analysis. Medtronic said they provide AI surgical insights across laparoscopic and robotic-assisted surgery. Along with the algorithms, Medtronic launched its Touch Surgery Live […]
Cardiawave names new CEO
French non-invasive ultrasound therapy (NIUT) device developer Cardiawave announced today it appointed Olivier Pierron as its new CEO. Levallois-Perret, France-based Cardiawave develops its Valvosoft NIUT device for the treatment of severe symptomatic calcific aortic stenosis. As CEO, Pierron holds responsibility for overseeing the deployment of Valvosoft in the European market and U.S. clinical trials. He […]
Medtronic unveils next-gen GI Genius software, partners with ModMed on AI-powered colonoscopy
Medtronic today announced advancements for its AI-powered GI Genius system, as well as a new collaboration. The company unveiled its ColonPRO latest-generation software for the GI Genius intelligent endoscopy system. GI Genius, a computer-aided polyp detection system powered by AI, has been available in the U.S. since 2021. Medtronic designed it to redefine GI screening by […]
Molli Surgical launches OncoPen 3D image guidance wand for breast cancer
Molli Surgical this week launched its OncoPen surgical tool for breast cancer imaging. The sleek, pen-like wand integrates with the Deerfield, Illinois-based company’s Molli 2 system to precisely target and remove cancerous lesions, according to Molli Surgical. It’s a minimally invasive tool with directional 3D guidance. OncoPen does not require wires and provides increased scheduling […]