FDA

Ultrahigh-speed multimodal adaptive optics system for microscopic structural and functional imaging of the human retina

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We describe the design and performance of a multimodal and multifunctional adaptive optics (AO) system that combines scanning laser ophthalmoscopy (SLO) and optical coherence tomography (OCT) for simultaneous retinal imaging at 13.4 Hz. The high-speed AO-OCT channel uses a 3.4 MHz Fourier-domain mode-locked (FDML) swept source. The system achieves exquisite resolution and sensitivity for pan-macular and transretinal visualization of retinal cells and structures while providing a functional assessment of the cone photoreceptors. The ultra-high speed also enables wide-field scans for clinical usability and angiography for vascular visualization. The FDA FDML-AO system is a powerful platform for studying various retinal and neurological diseases for vision science research, retina physiology investigation, and biomarker development

Deep learning-enabled volumetric cone photoreceptor segmentation in adaptive optics optical coherence tomography images of normal and diseased eyes

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Deep learning-enabled volumetric cone photoreceptor segmentation in adaptive optics optical coherence tomography images of normal and diseased eyes Objective quantification of photoreceptor cell morphology, such as cell diameter and outer segment length, is crucial for early, accurate, and sensitive diagnosis and prognosis of retinal neurodegenerative diseases. Adaptive optics optical coherence tomography (AO-OCT) provides three-dimensional (3-D) visualization of photoreceptor cells in the living human eye. The current gold standard for extracting cell morphology from AO-OCT images involves the tedious process of 2-D manual marking. To automate this process and extend to 3-D analysis of the volumetric data, we propose a comprehensive deep learning framework to segment individual cone cells in AO-OCT scans. Our automated method achieved human-level performance in assessing cone photoreceptors of healthy and diseased participants captured with three different AO-OCT systems representing two different types of point scanning OCT: spectral domain and swept source.

Dr Michael Chiang Chronicles the NEI’s Research Into AI, Telemedicine in Ophthalmology

Advances in imaging and data science are changing the nature of retina practice, and retina specialists need to stay on top of these, said Michael F. Chiang, MD, director of the National Eye Institute (NEI), who also discussed some of the current research the agency is conducting into artificial intelligence (AI) and telemedicine. ( Read Full Article )

TRANSFORM 1 enrollment completed: A crucial RCT ready to redefine the DCB Angioplasty Mechanism

Concept Medical announces the successful completion of the TRANSFORM 1 RCT (TReAtmeNt of Small coronary vessels: Randomized controlled trial FOR (https://www.conceptmedical.com/product/magic-touch) MagicTouch Sirolimus Coated Balloon).... This trial, testing DCB in small vessels has (re)discovered the basic mechanism of balloon angioplasty, beautifully documented by OCT prior to the application of the drug coating and will provide a wealth of mechanistic factors determining the angiographic and clinical outcomes of this treatment. OCT with machine learning will tell us what the impact is of tissue composition and the prognostic significance of the 'therapeutic dissection', a ubiquitous phenomenon after balloon angioplasty. I am more than ever excited and anxious to see the angiographic results," Prof. Patrick Serruys (Co-chair) quoted. TRANSFORM 1 RCT is exploring the uncharted field of small vessels. The primary objective of the study is to assess angiographic outcomes in respect t...

Raymond James stays bullish on Perimeter Medical

Perimeter released its second quarter 2022 financials on Wednesday, showing revenue of $19,500 with a net loss of $0.4 million. The company had cash and equivalents at the end of the Q2 of $45.0 million with $0.2 million of debt. ( Read Full Article )

Perimeter Medical Imaging AI and Pavilion Surgery Center Announce Placement of Perimeter S-Series OCT for Use at Ambulatory Surgery Center in Orange, CA

Pavilion Surgery Center, an affiliate of St. Joseph Hospital, along with Perimeter Medical Imaging AI, Inc. (TSX-V:PINK)(OTC:PYNKF) (FSE:4PC) (“Perimeter” or the “Company”) – a medical technology company driven to transform cancer surgery with ultra-high-resolution, real-time, advanced imaging tools to address high unmet medical needs – today jointly announced the first commercial placement of the Perimeter S-Series OCT system in the state of California at Pavilion Surgery Center in Orange, CA. The new medical imaging technology will be used under the direction of Michele Carpenter, MD, a breast surgeon who performs breast conservation and other surgeries at Pavilion Surgery Center. Perimeter S-Series OCT received FDA 510(k) clearance in 2021 and is a medical imaging tool that uses Optical Coherence Tomography (OCT) to provide clinicians with cross-sectional, real-time margin visualization (1-2 mm below the surface) of an excised tissue specimen. ...

Remidio’s Medios AI shows significant promise in last-mile Screening for Referable Glaucoma

Remidio Inc , alongside Aravind Eye Hospital (AEH), Pondicherry, and Narayana Nethralaya (NN), Bangalore , announced the results of a landmark clinical trial that can help revolutionize the detection of Referable Glaucoma. The integrated solution provides an instant report in contexts where there are no specialists. It consists of Remidio's Fundus on Phone , an imaging device that captures images of the retina without pupil dilation, and Remidio's Medios Referable Glaucoma AI, an integrated offline AI algorithm that requires no internet for inferencing. The AI looks beyond the cup-to-disc ratio and detects structural changes in the optic nerve head and surrounding retinal nerve fiber layer, critical regions typically assessed by glaucoma specialists during clinical examination with an expensive device called Optical Coherence Tomography. This video shows how technology can screen for Referable Glaucoma in 15 seconds. The diagnostic performance of the AI was validated in a first-ever...

Artificial Intelligence Enhances Potential of Intravascular OCT

Artificial intelligence ’s (AI) applicability in cardiac imaging is rapidly growing and was a major topic of discussion at this year’s EuroPCR 2022 meeting. Many session speakers discussed how they are using AI tools in their day-to-day practice and in their research to improve decision-making and patient/research outcomes. It’s no secret, however, that AI tools are only as good as the data sets and the thousands of expert opinions used to power them. Implementing AI applications in our day-to-day practice, from an operations standpoint, could mean adjusting clinician workflows and setting aside time to set up and train on the new systems. And from an efficacy standpoint, it leaves clinicians wary of result accuracy, especially if they are unsure how good the data used to power the technology really is. However, a good AI tool enhances workflow, has a proven ROI and is trained using data samples representative of our population and a variety of expert opinions. Whe...

Efficacy of Notal Vision Home OCT demonstrated by a series of scientific and clinical work

Multiple investigators show effectiveness of Home-OCT based remote monitoring model Manassas Notal Vision, Inc. reported today that numerous scientific and clinical publications and presentations prove the feasibility and efficacy of their patient-operated, home-based optical coherence tomography (OCT) device. As part of a comprehensive remote monitoring service, which includes a monitoring center and artificial intelligence algorithms for information processing, the Notal Home OCT effectively monitors wet age-related macular degeneration (AMD) treatment between doctor’s office visits. Wet AMD is the leading cause of blindness in people over 50 in the United States. Several treatments have been developed over the last two decades and have proven to be extremely beneficial. However, therapy requires frequent office visits for disease monitoring, placing a major burden on physicians, patients, and their caregivers. This burden has contributed to the limited real-world efficacy...

OncoRes Medical raises another $12.5M

OncoRes Medical announced that it raised $12.5 million for its handheld imaging device for identifying cancer cells. Perth, Western Australia-based OncoRes designed its imaging system to facilitate real-time tumor assessment, helping surgeons more accurately identify and remove cancerous tissue, including for breast cancer . The company won FDA breakthrough device designation in October 2020 for the device aimed at enabling surgeons to remove all cancer on the first try, thus avoiding a second procedure. When the handheld probe is applied to a region of interest, it provides micro-scale maps of the stiffness of the tissue — a key differentiator from healthy tissue — giving the surgeon the opportunity to remove the cancerous tissue. According to a news release, the company raised $9.5 million in a Series A2 funding co-led by Brandon Capital and Australian Unity’s Future of Healthcare Fund. The company added $3 million to that total with a Cooperative Research Centre...

Dragonfly OpStar OCT Catheter Recalled for Loose Marker Band

Abbott has recalled its Dragonfly OpStar imaging catheter, used for imaging the coronary arteries with optical coherence tomography, due to the possibility that the marker band farthest from the tip of the catheter could become loose and harm the patient, the US Food and Drug Administration announced Thursday . The recall has been deemed Class I, the most serious type. The issue has been associated with five incidents and one injury, but no deaths. In two cases, the loose band separated completely from the catheter while it was in use. If that happens and the band remains behind in the patient, it could cause vascular injury or death, according to the FDA note. The recall, which Abbott initiated on April 11, applies to 4,800 devices distributed in the United States. Affected catheters, with lot numbers listed in the FDA’s recall database , should be returned to the company. ( Read Full Article )

Abbott’s imaging catheter recall gets Class I label from FDA over vascular injury risks

The Food and Drug Administration has categorized Abbott Laboratories’ recall of 4,800 Dragonfly OpStar Imaging Catheters as a Class I event, reflecting the potential for a problem with the device that could lead to vascular injuries. Abbott issued an urgent notice about the catheters last month to warn customers of the risk of proximal markers separating from the devices. At the time, the company had received five complaints including one case of an embolism that required further intervention. According to the FDA’s Thursday notice, no deaths have been associated with the use of the device due to the recall issue. The FDA and Abbott are asking customers with affected devices to stop using them immediately and return all stock to the company. No action is required when affected devices have already been used successfully. A Class I label is the agency’s most serious recall classification. ( Read Full Article )

Collaboration Between Seno Medical and Cogmedix Drives GOLDEN Results for Innovative Medical Breast Imaging System

Cogmedix, a wholly-owned subsidiary of Coghlin Companies, Inc., and provider of FDA -compliant medical device engineering and manufacturing services, is proud to share that longtime customer, Seno Medical Instruments, Inc., has been selected as a GOLD winner for the 2022 Medical Device Excellence Awards in the Radiological, Imaging, and Electromechanical Devices category. This premier award program recognizes medical device companies that have demonstrated outstanding achievement and their contributions to improving the quality of healthcare worldwide. The Imagio� Breast Imaging System Seno Medical, a pioneer in the development of opto-acoustic ultrasound technology, was awarded this prestigious honor for their Imagio® Breast Imaging System . Imagio® is a non-invasive breast imaging system that utilizes optical coherence tomography (OCT) to provide high-resolution images of breast tissue fused with ultrasound, helping physicians better differentiate between benign and malign...

Postdoctoral Fellow in Adaptive Optics Optical Coherence Tomography in Multiple Sclerosis at University of Maryland

The Department of Neurology, Division of Multiple Sclerosis and Neuroimmunology at the University of Maryland School of Medicine is recruiting for a highly qualified postdoctoral researcher to perform clinical research related to the use of adaptive optics (AO) techniques as applied to optical coherence tomography (OCT) and scanning laser ophthalmoscopy (SLO). These techniques allow visualization of the living human retina at the level of single cells. The laboratory of Dr. Daniel Harrison at the University of Maryland is collaborating with the laboratories of Drs. Zhuolin Liu and Daniel X. Hammer at the Food and Drug Administration (FDA) to perform clinically oriented research projects related to the use of this technology to better understand and monitor the pathology of multiple sclerosis. The candidate will participate directly in this collaboration. More specifically, the candidate will be expected to: conduct human imaging in healthy and diseased eyes, perform data collection....

Conavi Medical’s Novasight Hybrid System Now In Use at Sunnybrook Health Sciences Centre

Conavi Medical Inc. ( www.conavi.com ), a leader of hybrid imaging guidance for common minimally invasive heart procedures, and Sunnybrook Health Sciences Centre , today announced that the Novasight Hybrid System is now being used for clinical procedures by interventional cardiologists as part of the Schulich Heart Program. Sunnybrook’s Schulich Heart Program is one of Canada’s leading cardiac and vascular care centres with an international reputation for pioneering some of the world’s most innovative ways to diagnose and treat the heart and damaged blood vessels. The hybrid intravascular ultrasound (IVUS) and optical coherence tomography (OCT) imaging platform, now called Novasight Hybrid System, was initially invented at Sunnybrook Research Institute (SRI) by Dr. Brian Courtney, a scientist and interventional cardiologist. It is the first and only clinical system available on the market that enables simultaneous and co-registered imaging of coronary arteries with...

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