Latest news with #InVue
Sydney Morning Herald
2 days ago
- Business
- Sydney Morning Herald
Melbourne breast cancer trial to test Optiscan imaging device
ASX-listed medical technology company Optiscan Imaging has started recruiting up to 50 patients for a Royal Melbourne Hospital clinical trial of its innovative precision surgery and digital pathology imaging devices, aiming to improve a common breast cancer surgery. The groundbreaking clinical study will utilise Optiscan's InVue microscopic precision surgery device, as well as its InForm digital pathology imaging system, to create a new, improved treatment regimen for breast cancer patients. The company will investigate the clinical workflow and real-time imaging capabilities of the two platforms in its first in-human breast cancer study. Optiscan will use data from the trial in its submissions for United States Food and Drug Administration (FDA) registration for the devices. Surgeons will use the InVue device during surgery to capture live imaging data from a woman's breast tissue after removing a tumour. It will provide the surgical team with immediate feedback on tumour clearance, ensuring there is a margin of healthy breast tissue around the site where the tumour was removed. Achieving a clear surgical margin, where no cancerous cells are left at the edges of the removed tissue, is critical to a patient's long-term health outcome but poses a significant surgical challenge. 'We believe our innovative real-time microscopic imaging platform represents a genuine breakthrough in surgical cancer management by bringing live cellular imaging to the bedside.' Optiscan Imaging chief executive officer and managing director Dr Camile Farah Using topical dyes, the removed tissue will then be examined with the InForm device to back up the InVue imaging. The additional InForm pathology data will be fed back into the company's imaging and pathology workflows ahead of its FDA application. The study will also incorporate InForm imaging of tissue samples taken chairside or from pathology laboratories to match its other ex vivo patient data. InForm can assess new tissue samples quickly and accurately with high resolution and magnification. While each device was designed to operate independently, Optiscan says it purposefully included both in the trial to maximise data collection, minimise the need to recruit patients into further trials and accelerate its regulatory submissions.
The Age
2 days ago
- Business
- The Age
Melbourne breast cancer trial to test Optiscan imaging device
ASX-listed medical technology company Optiscan Imaging has started recruiting up to 50 patients for a Royal Melbourne Hospital clinical trial of its innovative precision surgery and digital pathology imaging devices, aiming to improve a common breast cancer surgery. The groundbreaking clinical study will utilise Optiscan's InVue microscopic precision surgery device, as well as its InForm digital pathology imaging system, to create a new, improved treatment regimen for breast cancer patients. The company will investigate the clinical workflow and real-time imaging capabilities of the two platforms in its first in-human breast cancer study. Optiscan will use data from the trial in its submissions for United States Food and Drug Administration (FDA) registration for the devices. Surgeons will use the InVue device during surgery to capture live imaging data from a woman's breast tissue after removing a tumour. It will provide the surgical team with immediate feedback on tumour clearance, ensuring there is a margin of healthy breast tissue around the site where the tumour was removed. Achieving a clear surgical margin, where no cancerous cells are left at the edges of the removed tissue, is critical to a patient's long-term health outcome but poses a significant surgical challenge. 'We believe our innovative real-time microscopic imaging platform represents a genuine breakthrough in surgical cancer management by bringing live cellular imaging to the bedside.' Optiscan Imaging chief executive officer and managing director Dr Camile Farah Using topical dyes, the removed tissue will then be examined with the InForm device to back up the InVue imaging. The additional InForm pathology data will be fed back into the company's imaging and pathology workflows ahead of its FDA application. The study will also incorporate InForm imaging of tissue samples taken chairside or from pathology laboratories to match its other ex vivo patient data. InForm can assess new tissue samples quickly and accurately with high resolution and magnification. While each device was designed to operate independently, Optiscan says it purposefully included both in the trial to maximise data collection, minimise the need to recruit patients into further trials and accelerate its regulatory submissions.
The Age
23-06-2025
- Business
- The Age
Optiscan teams up with US drugmaker to support FDA submissions
Optiscan Imaging has fired a major shot in a bid to expand into the lucrative United States medical imaging market by inking a blockbuster five-year deal with American pharmaceutical outfit Long Grove Pharmaceuticals. The exclusive collaborative agreement will see Long Grove's fluorescein sodium contrast dye, AK-FLUOR, supplied for use in Optiscan's InVue imaging system in clinical studies, starting with breast surgery. Long Grove was founded by US healthcare investor Water Street and is known for its high-quality, cost-effective drug formulations. The company is the legal manufacturer of AK-FLUOR dye. The contrast dye is used to highlight cellular structures for medical imaging during surgery. Optiscan already uses the dye with its InVue fluorescence-based endomicroscopic imaging technology. 'AK-FLUOR will be used in combination with our fluorescence-based endomicroscopic imaging devices to undertake studies and clinical trials.' Optiscan chief executive officer and managing director Dr Camile Farah The two companies have teamed up to explore and support new clinical uses for the injectable dye and will initially focus on breast surgery. The deal is expected to expand into gastrointestinal endoscopy, robotic-assisted surgery and laparoscopic procedures. The data generated from the trials will be used to fast-track United States Food and Drug Administration (FDA) approvals for both the device and the drug, potentially unlocking broader commercial use and a quicker route into the US market. As part of the deal, Optiscan will get valuable information about how AK-FLUOR works in the body and how it's manufactured. In return, Long Grove will receive support for new FDA applications if new therapeutic uses of its drug in microscopic imaging come to light from the trials. Optiscan chief executive officer and managing director Dr Camile Farah said: 'For Optiscan, the agreement gives us a supply of Long Grove's AK-FLUOR, which will be used in combination with our fluorescence-based endomicroscopic imaging devices to undertake studies and clinical trials. The data flowing from these studies will be an invaluable resource for our regulatory submissions. For Long Grove, the collaboration should hopefully identify new uses for its drug.'
Sydney Morning Herald
23-06-2025
- Business
- Sydney Morning Herald
Optiscan teams up with US drugmaker to support FDA submissions
Optiscan Imaging has fired a major shot in a bid to expand into the lucrative United States medical imaging market by inking a blockbuster five-year deal with American pharmaceutical outfit Long Grove Pharmaceuticals. The exclusive collaborative agreement will see Long Grove's fluorescein sodium contrast dye, AK-FLUOR, supplied for use in Optiscan's InVue imaging system in clinical studies, starting with breast surgery. Long Grove was founded by US healthcare investor Water Street and is known for its high-quality, cost-effective drug formulations. The company is the legal manufacturer of AK-FLUOR dye. The contrast dye is used to highlight cellular structures for medical imaging during surgery. Optiscan already uses the dye with its InVue fluorescence-based endomicroscopic imaging technology. 'AK-FLUOR will be used in combination with our fluorescence-based endomicroscopic imaging devices to undertake studies and clinical trials.' Optiscan chief executive officer and managing director Dr Camile Farah The two companies have teamed up to explore and support new clinical uses for the injectable dye and will initially focus on breast surgery. The deal is expected to expand into gastrointestinal endoscopy, robotic-assisted surgery and laparoscopic procedures. The data generated from the trials will be used to fast-track United States Food and Drug Administration (FDA) approvals for both the device and the drug, potentially unlocking broader commercial use and a quicker route into the US market. As part of the deal, Optiscan will get valuable information about how AK-FLUOR works in the body and how it's manufactured. In return, Long Grove will receive support for new FDA applications if new therapeutic uses of its drug in microscopic imaging come to light from the trials. Optiscan chief executive officer and managing director Dr Camile Farah said: 'For Optiscan, the agreement gives us a supply of Long Grove's AK-FLUOR, which will be used in combination with our fluorescence-based endomicroscopic imaging devices to undertake studies and clinical trials. The data flowing from these studies will be an invaluable resource for our regulatory submissions. For Long Grove, the collaboration should hopefully identify new uses for its drug.'
Sydney Morning Herald
27-05-2025
- Business
- Sydney Morning Herald
Optiscan software breakthrough will bring pathologists to the bedside
ASX-listed medical technology innovator Optiscan Imaging has just fired a major shot across the bow of the global diagnostics industry with the launch of its game-changing cloud-based telepathology platform prototype. The company confirmed it has reached the minimum viable product (MVP) stage for its secure streaming software, developed in collaboration with Canadian software firm Prolucid Technologies. Successful beta-testing of the new software means pathologists could soon dial in from anywhere in the world to stream live, high-resolution tissue scans captured by clinicians in real time via a secure cloud connection - whether a hospital theatre, remote clinic or a clinician in the deep Outback. In addition to viewing images, pathologists will be able to flag key areas, annotate pictures, generate reports and collaborate with surgeons or imaging specialists live or on demand. 'This platform is a potential game changer for global digital pathology.' Optiscan Imaging chief executive officer and managing director Dr Camile Farah The platform is designed to integrate seamlessly with Optiscan's range of digital imaging devices, including the company's InVue, InForm and InVivage systems. Optiscan Imaging chief executive officer and managing director Dr Camile Farah said: 'This platform is a potential game changer for global digital pathology, with particular relevance to regional, rural and remote healthcare settings where access to pathology expertise is limited. Our telepathology solution essentially brings the pathologist into the heart of the operating theatre and bridges the gap between surgery and pathology.' Optiscan says security is top of mind. All communications are encrypted, with personal patient data hidden or made anonymous. Only registered devices with valid digital certificates can access the system, which uses a WebRTC-based protocol to keep the upload lag time under half a second. The system has been designed as a Software as a Medical Device (SaMD), meaning it's ready to slot into everyday clinical use. It will let doctors stream images directly to each other, review scans later, share second opinions and generate reports - all while keeping patient data safe and secure.
