Operating

VUZE Medical to Showcase Next Generation Software-based Guidance System for Spine Surgery at NASS 2023 Following FDA Filing

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화요일, 10월 10, 2023
Medical Supplies, Health, FDA, Technology, Surgery, Health Technology, Software, VUZE, Food, 3D, Red, U.S. FDA, NASS, CT, Clinical trial, Surgeon, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Operating, Medical imaging, MISS

VUZE Medical , a privately-held company aiming to transform intra-operative guidance in minimally invasive spinal interventions, has submitted a 510(k) filing with the U.S. Food and Drug Administration (FDA) for VUZE 2.0, its second generation VUZE System .

Key Points: 
  • VUZE Medical , a privately-held company aiming to transform intra-operative guidance in minimally invasive spinal interventions, has submitted a 510(k) filing with the U.S. Food and Drug Administration (FDA) for VUZE 2.0, its second generation VUZE System .
  • The VUZE System is a software solution installed on an off-the-shelf PC.
  • The VUZE System previously received U.S. FDA 510(k) clearance in 2022 and completed a successful first-in-human clinical trial in early 2023.
  • “Our second generation aims to extend the operability of the VUZE System across a much larger percentage of operating rooms,” said David Tolkowsky, founder and CEO of VUZE Medical.

PathKeeper Surgical Demonstrates New Technology at Prestigious North American Spine Society Annual Meeting

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목요일, 10월 12, 2023
Health, KFAR, North American Spine Society, NASS, Radiation, Spine, FDA, Federal Food, Drug, and Cosmetic Act, Surgeon, Operating, Medical imaging

KFAR SABA, Israel, Oct. 12, 2023 /PRNewswire-PRWeb/ -- PathKeeper Surgical, a privately-held, Israel-based, medical technology company, dedicated to improving the health of individuals around the world suffering from all spinal issues requiring surgery, while making navigation-guided surgery available to any patient in all operating rooms, today announces its participation in the upcoming North American Spine Society (NASS) 2023 Annual Meeting at the Los Angeles Convention Center, Los Angeles, CA, from October 18 to 20, 2023.

Key Points: 
  • The PathKeeper 3D Optical Navigation System aims to improve clinical experience and reduce the reliance on radiation in spine surgery.
  • The PathKeeper System was designed to replace traditional navigation technology with an active, independent and precise 3D optical navigation system.
  • "The United States represents a strategically important market for commercializing the PathKeeper System and the NASS annual meeting is the ideal environment to demonstrate our technology to spine surgeons from the United States and around the world," said Erez Lampert, Chief Executive Officer and Founder of PathKeeper Surgical.
  • PathKeeper Surgical received its FDA 510k clearance earlier this year for the PathKeeper System.

MCRA Assists Attune Medical on FDA De Novo Marketing Authorization for ensoETM™ Esophageal Thermal Regulating Device

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수요일, 10월 11, 2023
Partnership, Senior, Esophagus, Physician, Quality assurance, MS, De novo, US, FHRS, Circulatory system, Culture, Strategic planning, FACC, Clinical trial, Classification, US Foods, Temperature, Patient, FDA, Product code, CMO, MCRA, Heart failure, Attune, PLLC, Operating, US FDA, Medical device, MD, Computer security, Electrophysiology, United States Navy

This new marketing authorization establishes a new Product Code, expanding the classification of ensoETM as a temperature regulation device for esophageal protection during cardiac ablation procedures.

Key Points: 
  • This new marketing authorization establishes a new Product Code, expanding the classification of ensoETM as a temperature regulation device for esophageal protection during cardiac ablation procedures.
  • Attune Medical is the pioneer of using the esophageal space to manage temperature and received its first De Novo authorization in 2015.
  • MCRA's Cardiovascular Regulatory experts assisted Attune Medical through regulatory strategy, pre-submission and De Novo submission to the US FDA utilizing the totality of clinical data available.
  • Together, Attune Medical and MCRA were able to present FDA with a sound regulatory approach, clear framing of complex datasets and a compelling benefit-risk assessment.

HemoSonics Wins Medical Device Network Excellence Award in Two Categories

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목요일, 10월 5, 2023
Hospital, Food, AUC, Business, Intelligence, Journal of Cardiothoracic Surgery, Intensive care medicine, Health, Coagulation, Artificial intelligence, FDA, New product development, Trauma, Cartridge, GlobalData, Regulation of tobacco by the U.S. Food and Drug Administration, Patient, Operating, Medical device

DURHAM, N.C., Oct. 5, 2023 /PRNewswire/ -- HemoSonics, a medical device company delivering individualized diagnostic solutions for acute care bleeding and the management of coagulation, announced today that the company has won in both the Product Launch and Business Expansion categories in the 2023 Medical Device Network Excellence Awards. HemoSonics' Quantra Hemostasis System provides comprehensive whole-blood coagulation analysis at the point of care in less than 15 minutes. Clinicians don't need to wait on test results during a serious life-threatening bleeding event, and, as a result, patients receive optimized interventions as quickly as possible and only when needed.

Key Points: 
  • DURHAM, N.C., Oct. 5, 2023 /PRNewswire/ -- HemoSonics , a medical device company delivering individualized diagnostic solutions for acute care bleeding and the management of coagulation, announced today that the company has won in both the Product Launch and Business Expansion categories in the 2023 Medical Device Network Excellence Awards .
  • HemoSonics' Quantra Hemostasis System provides comprehensive whole-blood coagulation analysis at the point of care in less than 15 minutes.
  • The Medical Device Network Excellence Awards is an independent recognition program powered by the business intelligence of GlobalData .
  • HemoSonics also received an innovative technology contract award from Vizient, opening the door for the System to be adopted by hospitals and academic medical centers across the United States.

Surgical Reality Pioneer, Beyeonics, Unveils New Chairman of the Board

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수요일, 10월 4, 2023
Surgeon, Perrigo, Operating, Patient, Physician, AR, Medtech, Management, Nursing, Ophthalmology, Neurosurgery

HAIFA, Israel, Oct. 4, 2023 /PRNewswire/ -- Beyeonics Surgical & Beyeonics Vision, pioneering MedTech sister companies in the field of digital surgical platforms for operating rooms, announces the appointment of Mr. Joseph C. Papa as Chairman of the Board of Beyeonics Surgical and as Board Member of Beyeonics Vision.

Key Points: 
  • HAIFA, Israel, Oct. 4, 2023 /PRNewswire/ -- Beyeonics Surgical & Beyeonics Vision, pioneering MedTech sister companies in the field of digital surgical platforms for operating rooms, announces the appointment of Mr. Joseph C. Papa as Chairman of the Board of Beyeonics Surgical and as Board Member of Beyeonics Vision.
  • This strategic decision reflects Beyeonics' commitment to spearheading its technological advancements in Ophthalmology and Neurosurgery.
  • Mr. Papa is renowned for his leadership as former Chairman and CEO of Bausch Health Companies Inc, as well as CEO and Chairman of a wide range of medical device and pharma companies, including Perrigo, Prometheus Biosciences and SparingVision.
  • I have confidence in Beyeonics' value proposition, which holds the potential to significantly transform the fields of Ophthalmology and Neurosurgery."

Ganymed Robotics Announces Appointment of Seasoned Leadership Team to Bring to Market Its Next Generation Surgical Technology

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화요일, 10월 3, 2023
Biotechnology, Technology, Other Health, Health, Biometrics, Robotics, Health Technology, Other Technology, Medical Devices, Software, Surgery, EOS, General counsel, Marketing, Person, Operating, TKA, Ganymed, Executive Committee, Popular Executive Committee of Valencia, EOS imaging, Elective surgery, Management, BAE Systems Electronic Systems

Former companies include ZimmerBiomet, Alphatec, EOS Imaging, Corwave, Beckton Dickinson, Robocath, Médecins Sans Frontières.

Key Points: 
  • Former companies include ZimmerBiomet, Alphatec, EOS Imaging, Corwave, Beckton Dickinson, Robocath, Médecins Sans Frontières.
  • The company aims to secure and standardize a complex surgical gesture, so that each patient gets the right, personalized care.
  • It has developed a proprietary technology platform built around two disruptive innovations: contactless localization of the bones and human-machine collaborative movement.
  • With the arrival of high-profile senior executives on its leadership team, Ganymed is ideally positioned to successfully accelerate the execution of its strategic, industrial, and operational development plan.

Sutter Health Welcomes Sansum Clinic into its Integrated Health System, Enhancing Access to High-Quality Care on California’s Central Coast

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금요일, 9월 29, 2023
Partnership, Face, Nursing, Ransohoff, Health, Medicine, History, Ambulatory care, Organization, Medicare, Operating, Patient, Investment, Physician, Central Coast, Growth, Sutter Health, Sansum Clinic, Hospital, Bert Sansum

Sacramento, Calif., Sept. 29, 2023 (GLOBE NEWSWIRE) -- Sutter Health, a leader in healthcare innovation, proudly announces Sansum Clinic is now part of its integrated healthcare system.

Key Points: 
  • Sacramento, Calif., Sept. 29, 2023 (GLOBE NEWSWIRE) -- Sutter Health, a leader in healthcare innovation, proudly announces Sansum Clinic is now part of its integrated healthcare system.
  • This partnership marks a significant step toward providing enhanced access to high-quality care for the communities along California’s Central Coast.
  • As part of today’s signing, Sutter and Sansum leaders will gather to tour the site of newly constructed operating rooms at Foothill Surgery Center.
  • “This partnership provides a great opportunity for growth and long-term stability for Sansum Clinic,” said Kurt N. Ransohoff, M.D., Sansum Clinic CEO and chief medical officer.

The 88th CMEF in Shenzhen Set to Spotlight Advancements in the Medical Equipment Industry

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월요일, 9월 25, 2023
Powerhouse, Infection, Bed, Hong Kong International Medical Devices and Supplies Fair, Elective surgery, GBA, Public, Unique, Statistics, Multimedia, Government, MRI, Operating, Radiosurgery, Disinfectant, Growth, R, Convention center, Medical device

CMEF Shenzhen will propel the medical equipment industry to the next level.

Key Points: 
  • CMEF Shenzhen will propel the medical equipment industry to the next level.
  • The scale of China's medical equipment industry has reached 730 billion yuan and it is projected this growth will continue.
  • CMEF is dedicated to industry trends, technological innovation, and fostering future business opportunities and development, contributing to the global advancement of the medical equipment industry.
  • The 88th CMEF brings together international medical equipment brands, distributors, agents, manufacturers, medical professionals, and industry/government representatives from the entire industry chain.

The 88th CMEF in Shenzhen Set to Spotlight Advancements in the Medical Equipment Industry

Retrieved on: 
월요일, 9월 25, 2023
Powerhouse, Infection, Bed, Hong Kong International Medical Devices and Supplies Fair, Elective surgery, GBA, Public, Unique, Statistics, Government, MRI, Operating, Radiosurgery, Disinfectant, Growth, R, Convention center, Medical device

CMEF Shenzhen will propel the medical equipment industry to the next level.

Key Points: 
  • CMEF Shenzhen will propel the medical equipment industry to the next level.
  • CMEF is dedicated to industry trends, technological innovation, and fostering future business opportunities and development, contributing to the global advancement of the medical equipment industry.
  • The 88th CMEF brings together international medical equipment brands, distributors, agents, manufacturers, medical professionals, and industry/government representatives from the entire industry chain.
  • It encompasses various sectors, including medical imaging, in-vitro diagnostics, medical electronics, medical optics, hospital construction, operating rooms, disinfection and infection control, medical consumables, and orthopedics.

Nano Dimension Enhances Board Governance Structure and Functionality

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금요일, 9월 15, 2023
Learning, National Semiconductor, Hebrew University of Jerusalem, General Electric, Tower Semiconductor, Nissan Cohen, Channy, Al-Quds, Research, Glass Lewis, Operating, Hospital, RET, Physics, 3D printing, Emmy Awards, ISS, Management, Automotive industry

Waltham, Mass., Sept. 15, 2023 (GLOBE NEWSWIRE) --   Nano Dimension Ltd. (Nasdaq: NNDM) (“Nano Dimension”, “Nano” or the “Company”), a leading supplier of Additively Manufactured Electronics (“AME”) and multi-dimensional polymer, metal & ceramic Additive Manufacturing (“AM”) 3D printers, today announced that its Board of Directors (“the Board”) has appointed Dr. Yoav Nissan-Cohen as Chairman of the Board, effective immediately.    Yoav Stern will continue as the Company’s Chief Executive Officer and Director. In addition, Col. (Ret.) Channa Caspi announced that she will be stepping down from the Board due to personal medical circumstances, effective immediately. Following the departure of Col. (Ret.) Caspi, the Board will be reduced from nine to eight directors.

Key Points: 
  • Waltham, Mass., Sept. 15, 2023 (GLOBE NEWSWIRE) --   Nano Dimension Ltd. (Nasdaq: NNDM) (“Nano Dimension”, “Nano” or the “Company”), a leading supplier of Additively Manufactured Electronics (“AME”) and multi-dimensional polymer, metal & ceramic Additive Manufacturing (“AM”) 3D printers, today announced that its Board of Directors (“the Board”) has appointed Dr. Yoav Nissan-Cohen as Chairman of the Board, effective immediately.
  • Channa Caspi announced that she will be stepping down from the Board due to personal medical circumstances, effective immediately.
  • Currently, Dr. Nissan-Cohen serves also as an executive board member in Weebit, a semiconductor company developing a new class of semiconductor memories.
  • Yoav Stern, CEO of Nano Dimension, commented, “We’ve considered feedback from our shareholders, as well as the recommendations of governance experts, ISS and Glass Lewis, and have decided to make changes to our Board that we believe will evolve and enhance our corporate governance.