Carthera announced today that it received FDA breakthrough device designation for its SonoCloud-9 system. Paris-based Carthera designed SonoCloud-9 for implantation in a skull window below the skin. Once in place, the device becomes invisible. When activated for a few minutes using a transdermal needle connected to an external control unit, it uses low-intensity pulsed ultrasound […]
Imaging
Sidekick Health and Eli Lilly partner on digital therapeutics for breast cancer
Sidekick Health today announced a collaboration on an integrated digital therapeutics solution in conjunction with Eli Lilly (NYSE:LLY). The collaboration between the companies will mark the first phase of a relationship between Sidekick and Lilly, which starts with a digital therapeutic offering for patients battling breast cancer. According to a news release, the first phase […]
Aerin Medical closes $60M equity financing
Ear nose and throat (ENT) treatment technology developer Aerin Medical announced today that it closed a $60 million equity financing. Sunnyvale, California-based Aerin’s financing was led by new investor Ally Bridge Group with participation from all existing major investors, including KCK MedTech, Questa Capital and OrbiMed. According to a news release, Aerin Medical intends to […]
DermaSensor raises $10M as it braces for U.S. launch
DermaSensor announced today that it raised an additional $10 million as it prepares for a commercial launch in the U.S. Miami, Florida-based DermaSensor’s $10 million fundraising accompanies news that the company met all primary endpoints for two FDA pivotal studies, setting it up to potentially offer the only FDA-cleared, automated skin cancer detection tool on […]
GE Healthcare debuts Allia Platform for image-guided therapies
GE Healthcare (NYSE:GE) announced today that it unveiled the new Allia platform for minimally invasive, image-guided surgery. Chicago-based GE Healthcare designed the platform through a multi-year collaboration with interventionists and surgeons with the ultimate goal of enhancing user experience, improving workflow efficiency and increasing the adoption of advanced image guidance in daily practice. According to […]
AI-powered scope developer says new FDA clearance opens the door for telehematology
Scopio Labs today announced FDA 510(k) clearance for its X100HT, which features a new slide loader that automatically prepares samples and feeds them into the digital blood scanner for AI-powered analysis. The Tel Aviv-based digital microscope developer said the technology eliminates the need for manual microscopic examination when reviewing white and red blood cells and […]
GE Healthcare unveils intelligent workload management software for radiologists
GE Healthcare (NYSE:GE) announced today that it has made available a new intelligent workload management solution for radiology. The company announced the new software platform for its PACS solutions, integrated with Q-IT’s (a Quantum Imaging & Therapeutic Associates subsidiary) Helix Radiology Performance Suite, at the Society for Imaging Informatics in Medicine (SIIM) 2022 Annual Meeting. […]
Two-year data backs Aerin Medical’s chronic rhinitis treatment
Aerin Medical announced today that a study of its RhinAer technology demonstrated success in treating chronic rhinitis patients. Sunnyvale, California–based Aerin Medical — one of MassDevice’s 20 medical device startups you need to know in 2020 — designed its RhinAer temperature-controlled radiofrequency (RF) technology to disrupt nerve signals that cause chronic rhinitis symptoms, including constant runny […]
Accuray partners with Limbus AI on adaptive radiotherapy
Accuray (Nasdaq:ARAY) and Limbus AI announced today that they are partnering to augment Accuray’s adaptive radiotherapy capabilities. The partnership aims to leverage Limbus’ artificial intelligence (AI)-driven auto contouring algorithms to enable a streamlined treatment planning process. Sunnyvale, California-based Accuray and Saskatchewan, Canada-based Limbus AI anticipate an integrated offering will be made available beginning in 2023, […]
GE Healthcare says recovery in supply of contrast media is on the way
GE Healthcare (NYSE:GE) announced today that it is on the way toward restabilizing its global supply of iodinated contrast media — a vital imaging agent. The company said its Shanghai facility, previously closed amid COVID-19 restrictions in China, will be close to 100% production capacity by next week. Said GE: “We will continue to work […]
Abbott imaging catheter recall flagged as Class I by FDA
The FDA has identified the Abbott (NYSE:ABT) recall of its Dragonfly OpStar Imaging Catheter as a Class I recall. That’s the most serious level of a medical device recall, carrying the risk of serious injury or death. Five incidents, one injury and zero deaths were reported when Abbott initiated the recall on April 11. The […]