Pulse Biosciences, Inc. has received FDA breakthrough device designation for its innovative pulsed field ablation system. Key highlights: 💓 The system uses CellFX nanosecond pulsed field ablation (nsPFA) technology for cardiac tissue ablation to treat AFib ⚡ It creates durable, transmural lesions in less than 2 seconds - 20x faster than current thermal methods 🛡️ Non-thermal mechanism reduces risk of collateral tissue damage 🔬 Pulse Biosciences, Inc. plans to pursue premarket approval to commercialize its nsPFA Cardiac Surgical System in the U.S. The company also expects to begin an AFib pivotal clinical trial in 2025. #MedTech #Cardiology #FDA #EPeeps
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Today, we announce the CLAAS® System was featured in a podium presentation at the Cardiovascular Research Technologies (CRT) 2024 conference. "These results are very encouraging, indicating the CLAAS implant appeared less thrombotic than the Watchman FLX in this in vitro blood loop model," commented Dr. William Gray. See the link for the press release below. https://lnkd.in/dqWRvBiU Check out #JACC: #Cardiovascular #Interventions to see the published article. https://lnkd.in/d7bWY9QU #Cardiology #LAAO #data #conformalmedical #claas #Afib #Cardiology #LAAO #data #conformalmedical #claas #Afib #CRT2024 #CardioTech #InnovationInTheHeartOfDC #ConformalMedica #interventionalcardiology #elecrophysiologist CAUTION: Investigational Device The CLAAS System is limited by Federal (or United States) law to investigational use.
Conformal Medical’s CLAAS® System Demonstrates Low… | Conformal
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CEO of Axol Bioscience, enabling “Better Human Disease Models” with iPSC technology in neurodegenerative disease
AMD Researchers and Scientists Are we close to a breakthrough for dry AMD? Age-related macular degeneration (AMD) is a leading cause of irreversible visual impairment, affecting over 200 million people. It can be split into two broad types: "wet" AMD (~10% of cases) and "dry" AMD, which accounts for around 90% of all AMD cases. Despite making up the vast majority of AMD cases, there is currently no treatment for the dry form of AMD. We're therefore pleased to hear about promising early results from the LIGHTSITE III trial looking into light therapy to treat dry AMD. The key details are: • Patients were treated using a photobiomodulation technique, where three wavelengths of light are used to stimulate the retinal pigment epithelium (RPE), enhancing the metabolic activity and survival of the RPE cells and, therefore, the photoreceptors that depend on them • After 13 months of treatment, 55% of treated eyes exhibited a significant increase in vision (>5 letters on the eye chart)and showed no increase in drusen, cell debris that is a common sign of dry AMD • A larger study, EUROLIGHT, will build on this study by collecting data from 500-1,000 patients across Europe who have been treated with photobiomodulation Read the study results here: https://hubs.la/Q02tTLZQ0 Human iPSC-derived RPE cells could offer a more physiologically relevant model system for pre-clinical research and drug discovery, helping to get more therapies to the clinical stage like the LIGHTSITE III study. Our friends at Phenocell are harnessing market-leading iPSC technology to build RPE cell models that can unlock new insights and therapies for dry AMD. Take a look at their work here: https://hubs.la/Q02tTGSK0 #drugdiscovery #biopharma #pharma #research #drugdevelopment #CRO #retinal
Are we close to a breakthrough for dry AMD? Age-related macular degeneration (AMD) is a leading cause of irreversible visual impairment, affecting over 200 million people. It can be split into two broad types: "wet" AMD (~10% of cases) and "dry" AMD, which accounts for around 90% of all AMD cases. Despite making up the vast majority of AMD cases, there is currently no treatment for the dry form of AMD. We're therefore pleased to hear about promising early results from the LIGHTSITE III trial looking into light therapy to treat dry AMD. The key details are: • Patients were treated using a photobiomodulation technique, where three wavelengths of light are used to stimulate the retinal pigment epithelium (RPE), enhancing the metabolic activity and survival of the RPE cells and, therefore, the photoreceptors that depend on them • After 13 months of treatment, 55% of treated eyes exhibited a significant increase in vision (>5 letters on the eye chart)and showed no increase in drusen, cell debris that is a common sign of dry AMD • A larger study, EUROLIGHT, will build on this study by collecting data from 500-1,000 patients across Europe who have been treated with photobiomodulation Read the study results here: https://hubs.la/Q02tTLZQ0 Human iPSC-derived RPE cells could offer a more physiologically relevant model system for pre-clinical research and drug discovery, helping to get more therapies to the clinical stage like the LIGHTSITE III study. Our friends at Phenocell are harnessing market-leading iPSC technology to build RPE cell models that can unlock new insights and therapies for dry AMD. Take a look at their work here: https://hubs.la/Q02tTGSK0 #iPSCs #AgeRelatedMacularDegeneration #AMD #RPE #photobiomodulation
LIGHTSITE III: 13-Month Efficacy and Safety Evaluation of... : RETINA
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Congratulations to the first implanters of the SynchroMed™ III intrathecal pump implanted in the US! This milestone is a chance to reflect on the years of thoughtful, patient-centric work from so many people, and to look ahead as we consider just how many more patients with chronic pain, cancer pain, and severe spasticity we will be able to help. Thank you to our Targeted Drug Delivery partners and community of First Implanters. Targeted Drug Delivery requires surgery. Surgical, device and drug complications can occur that may be life-threatening or fatal. See risk information: https://bit.ly/3NCUsKw Medtronic announced FDA approval of the new SynchroMed™ III implantable drug delivery system in October 2023, and is excited to announce the first clinicians to implant SynchroMed(TM) III: Chris Beuer M.D., Anjum Bux M.D., Michael Danko, M.D., Tammy Dann, DO, MPH, Jay S Grider DO, PhD, MBA, M.D., Maged Hamza, M.D., John Hatheway M.D., Thor Johnson, M.D., @Denis Patin, M.D., Joshua Wellington M.D. Talk to a Medtronic Representative to learn more about TDD and the new SynchroMed™ III intrathecal pump. #TDDSynchroMedIII #MDTPainInterventions #TDD
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Are we close to a breakthrough for dry AMD? Age-related macular degeneration (AMD) is a leading cause of irreversible visual impairment, affecting over 200 million people. It can be split into two broad types: "wet" AMD (~10% of cases) and "dry" AMD, which accounts for around 90% of all AMD cases. Despite making up the vast majority of AMD cases, there is currently no treatment for the dry form of AMD. We're therefore pleased to hear about promising early results from the LIGHTSITE III trial looking into light therapy to treat dry AMD. The key details are: • Patients were treated using a photobiomodulation technique, where three wavelengths of light are used to stimulate the retinal pigment epithelium (RPE), enhancing the metabolic activity and survival of the RPE cells and, therefore, the photoreceptors that depend on them • After 13 months of treatment, 55% of treated eyes exhibited a significant increase in vision (>5 letters on the eye chart)and showed no increase in drusen, cell debris that is a common sign of dry AMD • A larger study, EUROLIGHT, will build on this study by collecting data from 500-1,000 patients across Europe who have been treated with photobiomodulation Read the study results here: https://hubs.la/Q02tTLZQ0 Human iPSC-derived RPE cells could offer a more physiologically relevant model system for pre-clinical research and drug discovery, helping to get more therapies to the clinical stage like the LIGHTSITE III study. Our friends at Phenocell are harnessing market-leading iPSC technology to build RPE cell models that can unlock new insights and therapies for dry AMD. Take a look at their work here: https://hubs.la/Q02tTGSK0 #iPSCs #AgeRelatedMacularDegeneration #AMD #RPE #photobiomodulation
LIGHTSITE III: 13-Month Efficacy and Safety Evaluation of... : RETINA
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EDAP completes enrollment in phase 3 study of Focal One HIFU therapy to treat deep infiltrating rectal endometriosis
No. 1 Pharma news weekly in the South Asian markets of India, Bangladesh, Pakistan, Nepal and Sri Lanka.
EDAP completes enrollment in phase 3 study of Focal One HIFU therapy to treat deep infiltrating rectal endometriosis https://lnkd.in/dUy33gvj EDAP TMS SA, the global leader in robotic energy─based therapies, announced that it has completed enrollment in its phase 3 study (Endo─HIFU─R2) evaluating Focal One High─Intensity Focused Ultrasound via https://www.pharmabiz.com/
EDAP completes enrollment in phase 3 study of Focal One HIFU therapy to treat deep infiltrating rectal endometriosis https://www.pharmabiz.com/NewsDetails.aspx?aid=166161&sid=2 EDAP TMS SA, the global leader in robotic energy─based therapies, announced that it has completed enrollment in its phase 3 study (Endo─HIFU─R2) evaluating Focal One High─Intensity Focused Ultrasound via https://ww...
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Are we close to a breakthrough for dry AMD? Age-related macular degeneration (AMD) is a leading cause of irreversible visual impairment, affecting over 200 million people. It can be split into two broad types: "wet" AMD (~10% of cases) and "dry" AMD, which accounts for around 90% of all AMD cases. Despite making up the vast majority of AMD cases, there is currently no treatment for the dry form of AMD. We're therefore pleased to hear about promising early results from the LIGHTSITE III trial looking into light therapy to treat dry AMD. The key details are: • Patients were treated using a photobiomodulation technique, where three wavelengths of light are used to stimulate the retinal pigment epithelium (RPE), enhancing the metabolic activity and survival of the RPE cells and, therefore, the photoreceptors that depend on them • After 13 months of treatment, 55% of treated eyes exhibited a significant increase in vision (>5 letters on the eye chart)and showed no increase in drusen, cell debris that is a common sign of dry AMD • A larger study, EUROLIGHT, will build on this study by collecting data from 500-1,000 patients across Europe who have been treated with photobiomodulation Read the study results here: https://hubs.la/Q02tTJKD0 Human iPSC-derived RPE cells could offer a more physiologically relevant model system for pre-clinical research and drug discovery, helping to get more therapies to the clinical stage like the LIGHTSITE III study. Our friends at Phenocell are harnessing market-leading iPSC technology to build RPE cell models that can unlock new insights and therapies for dry AMD. Take a look at their work here: https://hubs.la/Q02tTN8m0 #iPSCs #AgeRelatedMacularDegeneration #AMD #RPE #photobiomodulation
LIGHTSITE III: 13-Month Efficacy and Safety Evaluation of... : RETINA
journals.lww.com
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EDAP completes enrollment in phase 3 study of Focal One HIFU therapy to treat deep infiltrating rectal endometriosis
No. 1 Pharma news weekly in the South Asian markets of India, Bangladesh, Pakistan, Nepal and Sri Lanka.
EDAP completes enrollment in phase 3 study of Focal One HIFU therapy to treat deep infiltrating rectal endometriosis https://lnkd.in/dUy33gvj EDAP TMS SA, the global leader in robotic energy─based therapies, announced that it has completed enrollment in its phase 3 study (Endo─HIFU─R2) evaluating Focal One High─Intensity Focused Ultrasound via https://www.pharmabiz.com/
EDAP completes enrollment in phase 3 study of Focal One HIFU therapy to treat deep infiltrating rectal endometriosis https://www.pharmabiz.com/NewsDetails.aspx?aid=166161&sid=2 EDAP TMS SA, the global leader in robotic energy─based therapies, announced that it has completed enrollment in its phase 3 study (Endo─HIFU─R2) evaluating Focal One High─Intensity Focused Ultrasound via https://ww...
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Our newest publication, which is an evaluation of thoracic aortic atherosclerosis in BAV and TAV patients through histology and imaging, is online! Bicuspid aortic valve (BAV) patients display less atherosclerosis in the thoracic aortic wall compared to tricuspid aortic valve (TAV) patients on histology, while equal amounts of calcific depositions were found on CT-scans. These results contribute to our knowledge about the role of atherosclerosis in BAV patients. I would like to thank all authors for their contribution to this paper! Nimrat Grewal, Robert Klautz, robert poelmann, Jan Lindeman, Ralf Sprengers and Lucia kroft. #bicuspid #aorticvalve #atherosclerosis https://lnkd.in/erSdCtJf
Thoracic aortic atherosclerosis in patients with a bicuspid aortic valve; a case–control study - BMC Cardiovascular Disorders
bmccardiovascdisord.biomedcentral.com
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📢NeuroOne Medical Technologies Corporation (NASDAQ: NMTC) Receives FDA 510(k) Clearance to Market its OneRF Ablation System The First FDA-cleared thin-film, sEEG-guided RF system capable of both recording electrical activity and ablating nervous tissue with the added benefit of temperature control; Marks the Company’s third FDA 510(k)-cleared device “When NeuroOne was founded, one of our ambitious goals was to be the first to develop and commercialize thin-film electrodes capable of performing both diagnostic and therapeutic functions and offer a better methodology to treat patients suffering from a variety of neurological conditions,” said Dave Rosa, CEO of NeuroOne Medical Technologies Corporation (NASDAQ: NMTC). “We believe we have the potential to dramatically change the way these surgeries are performed so that patients may only need to go through surgery once for both diagnostic and therapeutic procedures. This may also reduce hospital stays, number of surgeries, and adverse events, while offering significant benefits from a clinical perspective. The addition of temperature control at the point of ablation also may enhance patient safety. Our team’s achievement in reaching this milestone was the culmination of years of perseverance, and I could not be more excited for our future. We are now preparing for a commercial launch either directly or through a strategic partner in the first half of calendar 2024.” Read more online: bit.ly/3Np7Fqb 📰 Follow Medical Device Developments to receive the latest medical device news daily and to subscribe to our weekly newsletter #MedicalDeviceDevelopments #neuroone
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