Concept Medical announced today that it commenced the FDA investigational device exemption (IDE) study of its MagicTouch system. MagicTouch, a sirolimus drug-coated balloon (DCB), treats in-stent restenosis (ISR) in coronary artery disease (CAD). Dr. Said Ashraf enrolled the first patient in the MAGICAL-ISR study at the AtlantiCare Institute in Atlantic City, New Jersey. The balloon […]
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CroíValve is set to challenge as tricuspid regurgitation treatment space heats up
With Edwards and Abbott making recent waves in the tricuspid regurgitation (TR) treatment space, CroíValve hopes to pave its own way. Edwards’ Evoque valve became the first transcatheter therapy to receive FDA approval to treat TR in February. This month, Abbott became the second with its TriClip transcatheter edge-to-edge repair (TEER) system picking up an […]
Smart AED maker Avive raises $56.6M
Connected automated external defibrillator (AED) maker Avive Solutions announced that it closed a $56.5 million growth equity financing. Questa Capital, Laerdal Million Lives Fund (LMLF) and Catalyst Health Ventures led the financing round. New investors, including RC Capital and Eckuity Capital, also participated. San Francisco-based Avive plans to use the funds to accelerate its commercial […]
Intuitive beats the Street in Q1, increases procedure volume forecast
Intuitive Surgical posted first-quarter results today that exceeded the consensus forecast on Wall Street while increasing its forecast for full-year procedure growth. The Sunnyvale, California-based surgical robotics leader reported profits of $545 million, or $1.51 per diluted share, for the three months ended March 31, 2024, up 53% from the first quarter of 2023. Total […]
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 […]
10 new, innovative medical devices to watch for in 2024
By Senior Editor Danielle Kirsh and Associate Editor Sean Whooley Significant medical device launches are coming in 2024. Think pulsed field ablation, diabetes treatment tech, surgical robotics and more. Pulsed field ablation news took over at the end of 2023 and the start of 2024, with Medtronic and Boston Scientific garnering significant regulatory approvals. Surgical […]
FDA approves Lumicell’s breast cancer visualization system
Lumicell today announced it received FDA approval for its LumiSystem direct visualization system for breast cancer removal. According to the company, the LumiSystem allows surgeons to scan the breast cavity post-lumpectomy in real time to detect and resect residual cancer that could have been missed with 84% diagnostic accuracy. The LumiSystem with the company’s LumiSight […]
Intuitive’s da Vinci 5 surgical robot has analysts confident in future growth
William Blair analyst Brandon Vazquez has increased confidence in Intuitive after viewing the new da Vinci 5 system at SAGES 2024. Vazquez said in a report that he has increased confidence in the company’s ability to drive growth over the next 5-10 years. He was particularly impressed with the system’s efficiency improvements and haptic feedback. […]
Fresenius Kabi has a Class I recall of Ivenix Infusion System software
The FDA this week labeled Fresenius Kabi’s recall of some Ivenix Infusion Systems (IIS) as Class I, the most serious kind. Fresenius Kabi USA issued the recall of Ivenix Infusion System LVP software, its infusion pump software, due to an issue of multiple software anomalies occurring that can potentially result in serious patient harm or […]
Analysts remain high on ResMed despite potential sleep apnea benefits from GLP-1s
William Blair analysts say that new data supporting the use of GLP-1s in patients with sleep apnea shouldn’t displace companies like ResMed in the market. GLP-1 receptor agonists, like Ozempic and Wegovy, provide therapy for diabetes and can lead to weight loss. Beyond impacting the diabetes industry, questions have arisen over their overall impact on […]
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 […]