While members of the U.S. FDA’s Imaging Drugs Advisory Committee weren’t blown away March 5 by the trial performance of Lumicell Inc.’s Lumisight (pegulicianine) in helping breast cancer patients avoid second surgeries due to negative margins following a lumpectomy, they voted 16-2, with one abstention, that the benefits of the imaging drug outweigh its risks, even though those benefits are incremental.
The March 5 meeting of the U.S. FDA’s Medical Imaging Drugs Advisory Committee could be the gateway to the first approved intraoperative technology for use in breast cancer that directly examines the lumpectomy cavity for residual cancer.
X-trodes Ltd. has received U.S. FDA 510(k) clearance for its Smart Skin solution, a wireless wearable technology that allows for medical-grade electrophysiological monitoring in clinics and at home. The company believes that the Smart Skin technology, which captures signals from the brain, heart, eyes and muscles, has the potential to significantly improve patient care.
Fraud on federal health programs often revolves around illicit billings for in vitro diagnostics, but the U.S. Department of Justice (DOJ) has added mobile cardiac positron emission tomography (PET) to the list of technologies that have been used to violate the law.
Legislation passed in the U.S. Congress in 2013 called upon the federal government to dispense with the Federal Helium Reserve by September 2021, a deadline that some stakeholders are grateful to see has passed without action.
Clarius Mobile Health Inc. received CE mark for its latest wireless hand-held whole-body ultrasound scanner, the Clarius PAL HD3. The scanner combines both phased and linear arrays on a single head which provides high image quality of superficial and deep anatomy allowing for better diagnostic capabilities and patient care.
Intravascular ultrasound is the preferred imaging modality for a number of procedures conducted on the circulatory system, including some procedures performed in the peripheral vasculature, but adoption is seen in some quarters as sub-optimal. A trio of medical journals have published a consensus statement pressing the case for more widespread utilization of IVUS for peripheral artery disease, but one of the sources of drag is poor Medicare reimbursement, a problem that might only be resolved in a piecemeal fashion.
Luma Vision Ltd. raised $22 million in financing that will allow the company to secure U.S. FDA approval and prepare for commercialization of its 4D cardiac imaging technology platform, Verafeye. The series A3 financing round was led by existing investors EQT Lifesciences, ABV Uni Fund and imec.xpand. Luma also added three new investors comprising an undisclosed multinational strategic investor, Atlantic Bridge Growth Fund and Bayern Kapital.
Respiratory imaging technology company 4Dmedical Ltd. is acquiring Imbio LLC for $45 million to create a comprehensive portfolio of cardiothoracic imaging technologies. The news comes on the heels of U.S. FDA clearance of 4Dmedical’s computed tomography lung ventilation analysis software in November 2023.
The Cari-Heart, a medical imaging technology which detects signs of inflammation around coronary arteries, can predict the risk of a cardiac event, independent from clinical risk scores and the interpretation of coronary computed tomography angiography (CCTA), according to data from a study presented at the recent American Heart Association Scientific Sessions.
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