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 […]
inHeart raises $4.2m
Cloud-based medical image analysis tech developer inHeart announced today that it closed a funding round worth $4.2 million (€3.7 million). Pessac, France-based inHeart, which provides image analysis for cardiac interventions on patients with arrhythmias, said in a news release that the funding round, led by Elaia, will be used to accelerate commercial development in Europe, […]
Axonics’ SNM system wins FDA nod for 3T-MRI scans
Axonics Modulation Technologies (NSDQ:AXNX) announced today that it has won FDA approval for full-body 3 Tesla (T) MRI scanning for patients implanted with its r-SNM sacral neuromodulation system. The premarket approval supplement represents an upgrade from a previous PMA conditional labeling for r-SNM, which allowed for for full-body scans using 1.5T MRI scanners. With this incremental […]
20 medical device startups you need to know
The medtech industry isn’t immune from COVID-19 troubles, but exciting innovation continues. These 20 medical device startups have grabbed our attention. Tom Salemi, DeviceTalks Editorial Director and Sean Whooley, Assistant Editor A number of medical device startups continue to make waves across the space, with new technologies and eye-watering fundraising rounds highlighting some exciting prospects. […]
Perimeter Medical Imaging to go public in Toronto
Perimeter Medical Imaging — creator of AI-based medical imaging tools for cancer surgery — plans to go public on the TSX Venture Exchange in Toronto on the week of June 29. The Toronto- and Dallas-based company is going public at the same time that it enters the commercial stage for its proprietary, FDA-cleared OCT imaging […]
GE Healthcare launches chest X-ray AI to better spot COVID-19
Officials at GE Healthcare (NYSE:GE) think the company’s new Thoracic Care Suite — a collection of eight AI algorithms from Lunit Insight CXR — could help clinicians in the fight against COVID-19. The AI suite, launched today, quickly analyzes chest X-ray findings and flags abnormalities for radiologist review, according to GE. It can spot potential pneumonia […]
Boston Scientific touts SpaceOAR meta-analysis results
Boston Scientific (NYSE:BSX) announced that published results from an analysis of its SpaceOAR hydrogel spacer revealed safe prostate-rectum separation. Marlborough, Mass.-based Boston Scientific has developed the SpaceOAR since its $600 million acquisition of Augmenix in September 2018. The absorbable polyethylene glycol hydrogel spacer won CE Mark approval in the European Union in 2010 and 510(k) clearance from the […]
Accuray launches CyberKnife S7 system
Accuray (NSDQ:ARAY) announced today that it launched its CyberKnife S7 system for stereotactic radiosurgery (SRS) and stereotactic body radiation therapy (SBRT). Using real-time artificial intelligence-driven motion tracking and synchronization, CyberKnife S7 offers treatments for SRS and SBRT in as little as 15 minutes, according to a news release. The system’s AI adapts radiation delivery to patient […]
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