implant device News
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Healionics’ Vascular Access Device Featured at American Society of Nephrology’s Kidney Week 2016
Healionics’ STARport HD, a novel preclinical stage implantable device that allows needle-free bloodstream access for hemodialysis treatment, has been selected by the American Society of Nephrology (ASN) to be featured at the ASN exhibit booth at Kidney Week 2016 as one of several new technologies portraying the future of kidney disease treatment. Kidney Week 2016 is the 50th annual kidney ...
By Healionics
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Graftys Announces Creation of an International Implant Registry to Follow up Graftys® HBS and Graftys® QuickSet
Aix-en-Provence, November 16th, 2015 – GRAFTYS SA, a company which develops and commercializes biomaterials used in orthopedic surgery, announces that it has recently established an ambitious Post Marketing Surveillance program, in the form of an internationally based registry of patients who have received implants of GRAFTYS® HBS and GRAFTYS® QuickSet. Both of these advanced ...
By Graftys
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Second Patent Issued for Healionics’ Textured STAR Biointerface
Healionics Corporation has received a further patent for its textured STAR Biointerface technology. The United States Patent and Trademark Office issued Patent No. 8,647,393, "Implantable Medical Devices Having Microporous Surface Layers and Method for Reducing Foreign Body Response to the Same.” This new patent extends the scope of 8,372,423 issued to Healionics in February 2013. The STAR ...
By Healionics
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DT MedTech Assumes Production and Distribution of Hintermann Series Lower Extremity Medical Devices
DT MedTech, LLC (DTMT) announced today that on May 1, 2016, it will officially take over all production, sales, and worldwide distribution of the Hintermann Series lower extremity device product line. Developed by prominent surgeon, Prof. Beat Hintermann, the line includes: (1) Hintermann Series H3 3-piece Total Ankle Replacement prosthesis, including the Standard and Revision models (formerly ...
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ASTM F1582 - 98(2011) Standard Terminology Relating to Spinal Implants
1. Scope 1.1 This terminology covers basic terms and considerations for spinal implant devices and their mechanical analyses. 2. Referenced Documents (purchase separately) ASTM Standards E6 Terminology Relating to Methods of Mechanical Testing E1150 Definitions of Terms Relating to Fatigue Index Terms 0 Spinal implants; Terminology--medical/surgical systems/applications ICS ...
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Healionics Announces New CEO
Healionics Corporation, a Seattle-based medical device company, today announced the appointment of Mike Connolly as Chief Executive Officer. Connolly brings 25 years of leadership in the medical device industry including extensive experience in both operating and venture investing roles. “We are fortunate to add a leader of Mike’s caliber,” said Andrew Marshall, Director and ...
By Healionics
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DT MedTech Secures CE Marking and Begins Active Distribution of Hintermann Series H3™ Lower Extremity Medical Devices
DT MedTech, LLC (DTMT) announced today that having secured CE Marking for the Hintermann Series H3 total ankle replacement devices, in compliance with mandatory European Directives, they are now actively selling and distributing their products outside the USA. The DTMT Hintermann Series products for the lower extremity include: (1) Hintermann Series H3 three-piece Total Ankle Replacement ...
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CVRx Launches new Barostlm NE02 Implantable Pulse Generator
The new Borostim NE02 Implantable Pulse Generator (IPG) launches in the U.S., improving the patient experience while on therapy and simplifying the implant procedure for physicians MINNEAPOLIS, Nov. 3, 2022 - CVRx, Inc. (NASDAQ: CVRX) ("CVRx"), developer of the world's first FDA-approved neuromodulation device to treat the symptoms of heart failure, has launched its new Barostim NE02™ IPG. ...
By CVRx
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vMap`s Role in Optimizing Non-Invasive Radio-Ablation Therapy presented at ACC.21 and THRS 2021.
A dual-center study reported that vMap™, as part of a new, non-invasive workflow - with Varian’s CRA system - improved efficiency and precision for radio-ablation therapy in these study subjects. The study showed that the radio-ablation administered as a part of the enhanced workflow also significantly reduced ICD shocks for patients receiving the therapy. Presented by its lead ...
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FDA approves first artificial iris
The U.S. Food and Drug Administration has announced its approval of the first stand-alone prosthetic iris in the United States that could help patients with certain types of eye damage see clearly and improve their appearance. The surgically implanted device, called the CustomFlex Artificial Iris, is meant to treat adults and children whose iris — the part of the eye that is colored around ...
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DT MedTech Acquires Worldwide Ownership of Hintermann Series of Lower Extremity Replacement and Revision Medical Devices
DT MedTech, LLC (DTMT) announced today that it has successfully completed the acquisition of ownership of the Hintermann Series lower extremity device product line. Developed by prominent surgeon, Professor Beat Hintermann, this exceptional product line includes: (1) the Hintermann Series H3 3-piece Total Ankle Replacement prosthesis (formerly known as the HINTEGRA Total Ankle Replacement ...
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LumaSense Introduces the New m924 OEM Module for Medical and Advanced Technology Applications
LumaSense Technologies, Inc.introduces the m924 Original Equipment Manufacturer (OEM) Module, designed to replace the LUXTRON m600 Series OEM Modules and FOT Lab Kit with better accuracy of +/-0.05 °C and a sample rate of 50Hz. This module was designed for -100 to 330 °C temperature monitoring in medical magnetic resonance imaging (MRI) and radio frequency (RF) OEM systems, implantable ...
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CVRx Launches a new Barostim Programmer
MINNEAPOLIS, July 12, 2022 - CVRx, Inc. (NASDAQ: CVRX) ("CVRx"), developer of the world's first FDA-approved neuromodulation device to treat the symptoms of heart failure, has launched its new Barostim Programmer, which was approved by the U.S. Food and Drug Administration (FDA) earlier this year. The second-generation programmer has a modernized design, operates on an upgraded cellular network ...
By CVRx
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Digital Image Correlation for Medical Implants
Too many measurements aren't made because they are difficult to make or inaccurate when made under live, realistic conditions. Digital Image Correlation (DIC) changes that and offers an efficient, non-contact way to measure motion and strain in real time. Use DIC as a non-contacting extensometer on flat or curved surfaces including wires during stress-strain tests. Identify stress concentrations ...
By Echobio, LLC
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NeuroSigma Receives FDA Breakthrough Device Designation for Monarch eTNS System®
NeuroSigma, Inc., a bioelectronic medical device company, today announced FDA Breakthrough Device Designation for its Monarch eTNS System® for “adjunctive use for reducing the frequency of seizures in individuals 18 years of age or older diagnosed with epilepsy characterized by partial-onset seizures, with or without secondary generalization, that are refractory to two or more ...
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Silver Bullet Therapeutics Reports Results of OrthoFuzIon Antimicrobial Bone Screw Testing Against the Top Six CDC Antibiotic Resistant “Superbugs”
Silver Bullet Therapeutics, Inc., a privately held medical device company that has developed an antimicrobial technology for implantable medical devices such as orthopedic bone screws, reported today the results of a study testing the “Time Kill” and “Adherence” effectiveness of its CE-marked OrthoFuzIon® Antimicrobial Bone Screw against the Top Six CDC ...
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Healionics raises $4.5M to fund first-in-human trial of STARgraft vascular graft
Healionics Corporation, a private medical device company, announced today the completion of a $4.5M convertible note financing round. The financing supports the first human study, currently underway, of the company's innovative STARgraft vascular graft. In preclinical studies, STARgraft demonstrated improved ability to maintain blood flow compared to on-market vascular grafts, thereby offering ...
By Healionics
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Microneedle patch technology shows potential for long-acting contraception
ATLANTA, January 14, 2019 – The laboratory of Prof. Mark Prausnitz at Georgia Tech developed dissolving microneedle patches that administer a long-acting contraceptive for more than 30 days using microneedle technology licensed exclusively to Micron Biomedical. This work was published in the journal Nature Biomedical Engineering on January 14, 2019. In the study conducted in animals, ...
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BSI extends healthcare rReach with Eurocat acquisition
BSI, the global standards and assessment body, has acquired German healthcare certification and testing business, EUROCAT. This development significantly enhances BSI’s ability to service the medical device market globally.EUROCAT is an established Notified Body offering healthcare systems and product certification. The company has a significant presence in Germany - the third largest medical ...
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Aziyo Biologics to Present at the H.C. Wainwright Bioconnect Virtual Conference
Aziyo Biologics, Inc. (Nasdaq: AZYO), a commercial-stage regenerative medicine company focused on creating the next generation of differentiated products and improving outcomes in patients undergoing surgery, today announced that members of management will present at the upcoming H.C. Wainwright Bioconnect Virtual Conference. A Pre-recorded presentation will be available on Monday, January 10th ...
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