Perimeter Medical Imaging AI Inc. secured FDA premarket approval for Claire, its AI-powered imaging device which detects difficult-to-see cancer during breast-conserving surgery. Claire combines AI with wide-field optical coherence tomography to provide surgeons with high-resolution, real-time views of excised tumor margins, to reduce the need for re-operations.
Atherectomy devices play a key role in dealing with calcified coronary arteries. But a study presented at this year’s Transcatheter Cardiovascular Therapeutics demonstrates that angioplasty balloons made a lot of headway in this clinical area, potentially pushing atherectomy devices into the fringes of routine practice.
Spectrawave Inc. surfed to a $50 million haul in its series B fundraising round for its Hypervue intravascular imaging system. The company appears to have captured the attention of at least one strategic investor, as Johnson & Johnson Innovation-JJDC Inc. led the round.
Boston Scientific Corp. is hoping to help change European guidelines on the use of intravascular imaging during percutaneous coronary intervention procedures, Emile Mehanna, medical affairs and medical education director, interventional cardiology, EMEA, told BioWorld.
No matter how you look at it, guiding percutaneous coronary interventions to treat complex lesions with optical coherence tomography (OCT) or intravascular ultrasound (IVUS) produces similar results in patients with complex lesions, a study presented Oct. 23 at the Transcatheter Cardiovascular Therapeutics (TCT) annual meeting in San Francisco indicated.
Notal Vision Inc. released two clinical reports it said prove the feasibility and efficacy of its patient-operated, home-based optical coherence tomography (OCT) device for monitoring wet age-related macular degeneration (AMD). This comes in the wake of a 2021 report that concluded patient operation of the Notal Vision Home OCT (NVHO) and its machine learning algorithm were generally on par with human experts evaluating retinal fluid and fluid volume in patients with AMD.
The FDA announced a class I recall of the Dragonfly Opstar imaging catheter by Abbott Vascular, of Santa Clara, Calif., due to the loosening of a band marker that may lead to separation from the catheter. The agency said two instances in which the marker has separated from the catheter have been reported, with another three incidents of loosening without separation.
Meduni Vienna, the Medical University of Vienna, Austria, is working on a novel eye scanner combining the structural and functional sensitivity of optical coherence tomography (OCT) with the chemical specificity of Raman spectroscopy, to acquire data from the living human eye.
PARIS – Damae Medical SAS has just raised nearly $6 million to develop new technology to detect skin cancer noninvasively without need for a biopsy. This series A round was led by BNP Paribas Développement SA and supported by original investors Kurma Partners SA and professional private equity fund, Paris Saclay Seed Fund.
PERTH, Australia – The FDA granted Oncores Medical Pty. Ltd. breakthrough device designation for its quantitative micro-elastography (QME) imaging system. The hand-held imaging tool helps surgeons differentiate between cancerous and healthy tissue in real time at the point of surgery, and it could substantially improve outcomes in breast-conserving surgery (BCS) and reduce repeat operations for women with breast cancer.
