Smith+Nephew (NYSE:SNN) today said it launched its RI Hip Navigation system for total hip arthroplasty. The technology is designed to maximize accuracy and reproducibility to deliver patient-specific component alignment for surgeons when assessing individual total hip arthroplasty cases. RI Hip Navigation helps surgeons take control of a patient’s pelvic tilt, leg length and offset measurement. It […]
Imaging
FDA clears Canon Medical AI-based image reconstruction tech
Canon Medical (NYSE:CAJ) announced today that it received FDA 510(k) clearance for its advanced intelligent clear-IQ engine (AiCE). Tustin, Calif.-based Canon Medical’s AiCE expands the company’s deep learning reconstruction (DLR) technology platform with its compatibility with the Vantage Orian 1.5T MR system for artificial intelligence-based imaging. It is also available with the Vantage Galan 3T MR […]
Paige pathology viewer lands FDA clearance
AI-aided pathology company Paige today announced it received FDA clearance for its FullFocus digital pathology image viewer for the purpose of primary diagnosis. This clearance allows in vitro diagnostic (IVD) use of FullFocus with the FDA-authorized Philips Ultra Fast Scanner and paves the way for IVD use of FullFocus with additional IVD whole slide imaging […]
Micro-X mobile X-ray system FDA cleared
Micro-X announced today that its Rover mobile X-ray product designed for military medical facilities received FDA 510(k) clearance. Adelaide, Australia-based Micro-X said in a news release that it initially developed the Rover product under contract from the Australian Defense Department to offer digital medical X-ray imaging technology that was light enough for deployment in field […]
FDA says Verathon recall of GlideScope Core smart cable is Class I
The FDA has declared the recall of a Verathon video laryngoscopy system is Class I, the most serious kind. Verathon’s GlideScope Core OneTouch smart cable is designed to offer views of the airway and vocal cords for medical procedures. The system’s Core OneTouch smart cable is used to connect the GlideScope spectrum single-use video laryngoscopes and […]
Sirius Medical raises nearly $5m to commercialize non-radioactive tumor localization system
Sirius Medical has raised €4.4 million ($4.9 million) as it seeks to commercialize its Sirius Pintuition non-radioactive tumor localization system. News of the money raise comes about a month after the Eindhoven, the Netherlands-based Sirius announced that it had won a CE Mark for the system. FDA clearance is pending. The Series A round was […]
Insightec wins Medicare coverage for incisionless neurosurgery platform
Insightec announced today that it has secured complete Medicare coverage across the U.S. for its MR-guided focused ultrasound treatment of medication-refractory essential tremor. The coverage comes roughly four years since the Tirat Carmel, Israel–based company won FDA approval for the technology. Insightec officials said compelling clinical evidence and support from physicians, specialty societies and patients […]
FDA clears Infervision’s lung CT.AI system
Infervision announced that it received FDA 501(k) clearance for its InferRead Lung CT.AI system which uses AI to automatically perform lung segmentation. InferRead Lung CT.AI is designed to use AI and deep learning technology to support concurrent reading and aid radiologists in pulmonary nodule detection during the review of chest CT scans, increasing accuracy and […]
FDA clears Therapixel’s Mammoscreen
Therapixel today said it received FDA 510(k) clearance for its MammoScreen artificial intelligence-used software. MammoScreen automatically detects and characterizes suspicious soft tissue lesions and calcifications in mammogram images while assessing malignancy. The results are then presented in a summary report that characterizes suspiciousness of lesions on a scale of 1 to 10, with one being […]
Hologic launches first cart-based ultrasound system in U.S.
Hologic (NSDQ:HOLX) announced today that it launched its SuperSonic MACH 40 premium, cart-based ultrasound system in the U.S. The Marlborough, Mass.-based company touts the SuperSonic platform as its first cart-based system, saying in a news release that the new system features strong image quality, standard-setting imaging modes and design to enhance efficiency and accuracy. SuperSonic uses […]
OneProjects raises $12m for development of its cardiac imaging system
OneProjects — an Irish-German cardiac imaging startup — announced today that it has raised $12 million (€11 million) in a Series A round. LSP, based in the Netherlands, investing from its LSP Health Economics Fund 2, and the Atlantic Bridge University Fund (Ireland), led the round, with participation from Enterprise Ireland and a selection of […]