medical device license News
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Biomatlante receives MDSAP Accreditation
Biomatlante, a world leader in synthetic bone regeneration technologies, is pleased to announce the obtention of the MDSAP* accreditation on the new ISO 13485:2016 Certificate. The Medical Device Single Audit Program (MDSAP) is an international program for assessing the quality management systems of medical device manufacturers who market their products in Australia, Brazil, Canada, Japan and/or ...
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Spectrum Dynamics Receives Approval from Health Canada for VERITON-CT64 Digital SPECT/CT
Spectrum Dynamics Medical, Inc., has received Canadian Medical Device License from Health Canada for its premium digital SPECT/ 64-sliceCT scanner, VERITON-CT64. VERITON-CT64 is designed for both, total body and organ-focused, hybrid imaging with shorter scan times, at lower injected activity when compared to current analog dual-detector technology. VERITON-CT64 SPECT/CT digital technology plus ...
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Proa Medical receives Device Manufacturing License from the State of California
Proa Medical, Inc. was granted a Device Manufacturing License by the Department of Public Health Food and Drug Branch of the State of California. "Proa Medical has a high commitment to quality and has created a culture of quality that reaches all aspects of its operations," said Proa Chief Operating Officer Afshin Nadershahi. "Our quality system an important asset that we are able to leverage in ...
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Scion Medical Technologies Receives CE Mark Clearance for Cassi Breast Biopsy System
Newton, MA– Scion Medical Technologies, LLC. has received CE Mark (Conformité Européenne) designation for the Cassi breast biopsy system. The CE Mark paves the way for the Cassi breast biopsy system to be offered to the European market. About Scion Medical Technologies Scion Medical Technologies (Scion) is a global medical device company with US headquarters in ...
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Exact Imaging’s Response to COVID-19
The world has been and continues to unite to “flatten the curve” of the outbreak of COVID-19. Exact Imaging began its support of this critical initiative on Friday March 13, 2020. We have implemented the following measures to ensure we protect and support our customers, employees, suppliers, and business: Observe Self-Isolation Guidelines – All Exact Imaging employees ...
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cion Hosts Symposium: Medical Devices in the Emerging Chinese Market
November 21, 2011 – Waltham, Massachusetts. Scion Medical Technologies co-hosted the symposium, “Medical Devices in the Emerging Chinese Market”. Scion and its co-host, CMC Group, the investment arm of China Medical City, a government backed life sciences economic zone in Taizhou, China, brought together a panel of leading medical device industry experts from the U.S. and China ...
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FUJIFILM VisualSonics and PIUR IMAGING Partner to Enable Ultra-High Frequency, 3D Ultrasound Imaging Technology
FUJIFILM VisualSonics, a global provider of ultra-high-frequency (UHF) ultrasound imaging systems, and PIUR IMAGING, the European leader in tomographic ultrasound imaging, have partnered to bring UHF, three-dimensional (3D) ultrasound imaging technology to clinicians and researchers. This technological advancement supports clinical research in the evaluation of anomalies in several applications, ...
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Exact Imaging secures CDN $5.1 Million in financing from BDC Capital and EDC
TORONTO, CANADA -- (March 23, 2021) Exact Imaging (www.exactimaging.com), the world’s leader in high resolution micro-ultrasound systems enabling real-time imaging and biopsy guidance for the prostate, announces $5.1M in financing provided by BDC Capital, through the Bridge Financing Program, and Export Development Canada (EDC). “We are thrilled to have BDC Capital and EDC as new ...
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Scion Acquires Soft Tissue Marker with FDA Marketing Clearance from Kent Medical Devices, Inc.
June 26, 2012 – Newton, Massachusetts. Scion Medical Technologies, LLC (Scion), a company that manufactures and sells products in the general surgery area, announced today that it has acquired a soft tissue marker product line with FDA marketing clearance from Kent Medical Devices, Inc. of Minneapolis, Minnesota. “The Kent Medical Devices soft tissue marker product line bolsters our ...
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Sommetrics Launches Pivotal Clinical Study of Its aerSleep II Product to Treat Sleep Apnea; Raises $11 Million in Series C Preferred Financing
VISTA, Calif. — September 29, 2021 — Sommetrics, a private company developing products and services to improve sleep health, today announced the launch of the pivotal clinical trial of its aerSleep® II device for the treatment of obstructive sleep apnea (OSA). This study is being conducted at 10 university and community-based sleep centers in the U.S. under an Investigational ...
By Sommetrics
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New Studies Examine the Use of ExactVu Micro-Ultrasound to Improve on Prostate MRI
Clinical evidence for micro-ultrasound is growing exponentially with publications from more than a dozen institutions reporting on more than 3,000 individual biopsy cases. Toronto, Canada -- (March 31, 2021) Exact Imaging™ (www.exactimaging.com), the world’s leader in high-resolution micro-ultrasound systems enabling real-time imaging and biopsy guidance for the prostate, and its ...
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Scion Acquires Soft Tissue Biopsy Product Line
June 15, 2012 – Newton, Massachusetts. Scion Medical Technologies, LLC (Scion), a company that manufactures and sells products in the general surgery area, announced today that it has acquired a suite of assets for soft tissue biopsy, including issued intellectual property for a novel approach in the field. Scion is completing the final stages of development of the product and plans to ...
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Queen’s University Radiology Receives Hyperfine Portable MRI to Improve Access to Care for Canadian Patients in Remote Northern Communities
Hyperfine, Inc. (Nasdaq:HYPR), creator of Swoop®, the first FDA-cleared portable magnetic resonance imaging (MRI) system™, is proud to announce that Queen’s University and Kingston Health Sciences Centre are deploying a Swoop system as part of their health services benefitting six communities located in the James Bay and Hudson Bay Area. Until now, patients needing routine or ...
By Hyperfine
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Scion Medical Technologies receives FDA 510 (k) clearance for the Cassi Beacon tissue marker
Newton, MA –Scion Medical Technologies, LLC announces the introduction of the Cassi™ Beacon™ tissue marker, the company’s newest addition to the Cassi™ breast biopsy product portfolio. The Cassi Beacon tissue marker is a single use marker which is placed into soft tissue during breast biopsy procedures to radiographically mark a surgical site for easy location ...
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How to License or Sell Your Medical Device Intellectual Property
Part I – Presenting Your Idea Anywhere during the product development cycle, it may make sense to discuss your medical device with potential acquirers. Licensing implies that you will still control the company that the technology was developed under and ONLY the intellectual property is transferred to the acquirer. A license can be exclusive (1 company) or non-exclusive (you can license ...
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Bardy Diagnostics Announces CE Mark Certification for 14-Day Carnation Ambulatory Monitor (CAM™) Patch in Europe and Expansion of Home Enrollment Program Amidst COVID-19 Crisis
SEATTLE, May 26, 2020 /PRNewswire/ — Bardy Diagnostics, Inc., (“BardyDx”), a leading provider of ambulatory cardiac monitoring technologies and custom data solutions, announced today it received CE mark certification for the 14-Day version of the Carnation Ambulatory Monitor (“CAM”) patch, the industry’s only P-wave centric ambulatory cardiac patch monitor and ...
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Scion Co-Sponsors Cassi II Breast Biopsy Device Ultrasound Training for Chinese Physicians
During the week of Monday, April 30 – Saturday, May 5, 2012, seven physicians from China will train with internationally distinguished interventional radiologist Ken Tomkovich, MD, director of breast imaging and interventional radiology at CentraState Medical Center and affiliated with Freehold Radiology Group. The training will cover the latest imaging and interventional radiology ...
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SANUWAVE Health Announces Issuance of Eleven New Patents Bringing the Company`s Total Number of Active Patents and Patent Applications to 150
SANUWAVE Health, Inc. (OTCQB:SNWV), a leading provider of next-generation advanced wound care medical systems for the repair and regeneration of skin and vascular structures and the research for new applications for shockwave systems in the non-medical field, announced today the patent activity for the full year 2020 and the first quarter of ...
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Alveo Technologies Awarded License from State of California Department of Public Health Food and Drug Branch
We are thrilled to announce today that in February 2020 Alveo Technologies was presented with a Food and Drug Branch License (FDB License) after an in-person inspection by a Food and Drug Investigator from the State of California Food and Drug Branch of the Food and Drug Administration. This license is critical to the success of our company as it is a requirement of the State of California in ...
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Neuspera Medical Completes First Implants of its Neuromodulation Device in its two-stage Pivotal Clinical Trial to treat Urinary Urgency Incontinence
Neuspera Medical Inc., a clinical stage, private venture capital backed neuromodulation company, today announced the closing of the company’s $65 million series C equity financing. The Series C round was co-led by Vertex Ventures HC and Treo Ventures. Lori Hu, a Managing Director at Vertex Ventures HC and Mudit K. Jain, Ph.D. Managing Partner, Treo Ventures, joined the Board of Directors. ...
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