Medical Device Management News
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CardioWise™ Receives ISO 13485:2016 Clearance for Design, Development, and Marketing of Software as a Medical Device (SaMD) For the Medical Device Industry
CardioWise, Inc., is pleased to announce that Perry Johnson Registrars, Incorporated has audited the CardioWise Quality Management System (QMS) and determined CardioWise is in conformance with ISO 13485:2016. Perry Johnson Registrars Certificate C2022-02910 was issued July 16, 2022, and represents the first step in the process of obtaining a CE mark and Medical Device Registration for the ...
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STEMart Launches Microbiology & Sterility Testing Services for Medical Devices
STEMart, a provider of integrated medical device CRO services dedicated to medical device and diagnostic clinical development, introduces comprehensive microbiology and sterility testing for sterile, non-pyrogenic products. STEMart has extensive expertise in microbiology as well as sterility testing and remains dedicated to a full-service experience that supports manufacturers in meeting ...
By STEMart
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New Bone Data Comparing ImpediMed’s SOZO to DXA in Cancer Patients to be Presented at 39th Annual Miami Breast Cancer Conference
ImpediMed Limited (ASX.IPD), a medical technology company that uses bioimpedance spectroscopy (BIS) technology to generate powerful data to maximize patient health is pleased to announce an abstract comparing concurrent measures using ImpediMed’s SOZO® Digital Health Platform and dual x-ray absorptiometry (DXA) for assessing in bone mineral content in cancer patients was accepted for ...
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New Data Show Statistically Significant Reduction in Chronic Cancer-Related Lymphedema with Early Detection Using ImpediMed’s L-Dex® Technology and Intervention
Lymphatic Research and Biology Publishes Data on PREVENT, the Largest Randomized Trial to Assess Lymphedema Prevention L-Dex Technology Provides a New Standard Approach for Prevention of Cancer-Related Lymphedema ImpediMed Limited (ASX: IPD), a global medical technology company using bioimpedance spectroscopy (BIS) to generate powerful data to maximize patient health, today ...
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City of Oulu outsources its sleep apnea screening to Nukute
City of Oulu, the high-tech capital of Northern Finland, has selected Nukute as the sole provider for the City’s sleep apnea screening service. Nukute’s service solution, powered by Nukute’s own CE-marked medical device innovation, facilitates a healthcare process that leads to a reduced need for specialised health care. The cost effectiveness the device and solution ...
By Nukute Oy
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Hyalex Receives ISO 13485 Certification
We are happy to announce that Hyalex Orthopaedics has received ISO 13485:2016 certification for Medical Device and Quality Management Systems. This certification is a regulatory requirement and international standard outlining requirements for a medical device quality management system. It brings Hyalex one step closer to the clinic and patients who may benefit from the HYALEX Cartilage System. ...
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Cairn Diagnostics Delivers Virtual Administration of its Novel 13C-Spirulina Gastric Emptying Breath Test
Cairn Diagnostics, an innovative leader in providing cutting-edge breath tests intended for routine use in diagnostic medicine, today announced that the U.S. Food and Drug Administration (FDA) has expanded the approval of the Company’s 13C-Spirulina Gastric Emptying Breath Test (GEBT) to now include “at home” administration under virtual supervision of Cairn Diagnostics. GEBT ...
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The American Academy of Orthopedic Surgeons has just recognized that when integrated in patient education, Knee Kinesiography with the KneeKG system provides statistically significant and clinically superior improvements compared to the results obtained w
Emovi inc. is pleased to announce that Geisinger Health, comprised of nine hospital campuses, two research centers, a college of medicine, and a 550,000-member health plan serving more than three million residents in central, south-central, and northeast Pennsylvania, broadens its care and support for patients experiencing knee pain with the addition of five KneeKG Systems into their clinics. ...
By Emovi
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Michael Herring Joins HD Medical as US Vice President of Sales
HD Medical, Inc., the leader in cardiovascular disease detection, today announces that Michael Herring has joined the team as the US Vice President of Sales. Herring brings his 25 years of experience in medical device sales to the company, having previously worked for 3M, Cantel Medical, Nanosonics, and TSO3. Herring plans to leverage his unique background in medical device sales management and ...
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EDGe Surgical Receives CE Mark Certification for EDG Ortho 65mm Electronic Depth Gauge
EDGe Surgical, Inc., a company focused on developing and manufacturing smart orthopedic and spine surgical instruments, announced today that it has received a CE Certificate of Conformity from its notified body permitting CE mark of the company’s EDG Ortho 65mm single-use electronic depth gauge in the European Union market. “This is a great achievement for EDGe Surgical on several ...
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NanoPin Technologies Announce a Strategic Collaboration with Shanghai Reigncom Biotechnology to Bring Novel Infectious Disease Diagnostic Products to the China Market
NanoPin Technologies (New Orleans, Louisiana, USA) announces the establishment of a strategic partnership with Shanghai Reigncom Biotechnology Co., Ltd. (Shanghai, China). NanoPin and Reigncom will work together to commercialize NanoPin’s high-sensitivity and high-specificity infectious disease detection technology on Reigncom's RZ-500 ultra-high performance liquid chromatography tandem ...
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Medical certification obtained for the products of the Vaud startup
SteriLux passes the course of medical certification for the European market, thus demonstrating that its technology meets the most demanding standards in the field of health. Sterilizing heat-sensitive medical instruments without chemicals: this is the objective that the Vaud-based startup SteriLux has set itself since its creation in 2014. Its product, of sustainable design, uses ...
By SteriLux SA
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BioVentrix Announces Jerry Estep, MD, as Co-Principal Investigator for ALIVE Pivotal Trial Studying a Transcatheter Device for Heart Failure
BioVentrix, Inc., a privately held medical device company focused on treating congestive heart failure (CHF) via Transcatheter Ventricular Restoration (TCVR), today announced that heart failure specialist Jerry Estep, MD, of the Cleveland Clinic has been appointed co-principal investigator of the pivotal ALIVE Trial studying LIVE Therapy using the Revivent TC TransCatheter Ventricular ...
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BlueWind Medical Strengthens Board of Directors with appointment of Kerry Nelson
BlueWind Medical, a medical device company developing minimally invasive neurostimulation devices, announced today the appointment of Kerry Nelson to the company’s Board of Directors. Nelson is a successful medical device investor and fund manager who has launched and managed healthcare focused investment funds. Over the course of her career, she has counseled public and private medical ...
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V-Wave Announces appointment of Bill Hughes as Chief Financial Officer
V-Wave Ltd., a cardiovascular device company developing proprietary, minimally invasive interatrial shunt devices for treating patients with severe symptomatic heart failure (HF) and pulmonary arterial hypertension (PAH), announced the appointment of Bill Hughes as its Chief Financial Officer (CFO) today. “We are thrilled to add someone with Bill’s talent and experience to the V-Wave ...
By V-Wave Ltd.
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Oncomfort and Vygon sign international partnership for commercialization of Sedakit™, the Digital Sedation™ Virtual Reality solution
Oncomfort, the Belgian inventor of Digital SedationTM - a new method for relieving patients’ pain and anxiety without medication –, and Vygon, global group specializing in single-use medical devices, today announce their commercial partnership in six European countries. The strong synergy between Vygon's specialization and Oncomfort's fields of application will enable greater ...
By Oncomfort
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BlueWind Initiates U.S. Enrollment in Clinical Trial of the RENOVA iStim to Treat Overactive Bladder
BlueWind Medical announced today that enrollment has commenced at U. S. sites in the Pivotal Clinical Trial of the RENOVA iStim™ implantable tibial neuromodulation System (RENOVA) for the treatment of Overactive Bladder (OAB) following conditional Investigative Device Exemption (IDE) approval by the U.S. Food and Drug Administration (FDA). There are approximately 40 million adults in the ...
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Lumendi Reports First Incisionless Appendectomy Using Double-Balloon Endolumenal Interventional Platform
Patient reported no post-procedure pain and resumed regular activity day after procedure Connecticut-based medical device innovator Lumendi, LLC reports the first endoscopic appendectomy using its DiLumenTM Endolumenal Interventional Platform (EIP). A patient underwent the purely endoscopic endolumenal appendectomy to remove a lesion previously identified at the appendiceal orifice. ...
By Lumendi Ltd.
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Early Trial Data Show Promise in Endoscopic Procedure Time Study
A STUDY EVALUATING ENDOSCOPIC PROCEDURE TIME REMOVING COMPLEX COLORECTAL POLYPS SHOWS SUPERIORITY OF LUMENDI’S DILUMEN DEVICE OVER A CONTROL GROUP. Connecticut-based medical device innovator Lumendi LLC reports that its 1:1 randomized trial of the DiLumen Endolumenal Interventional Platform (EIP) successfully met the primary endpoint of an IRB-approved 200-patient prospective study. The ...
By Lumendi Ltd.
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Lumendi Reports Successful Enrollment Closure of Its Dilumen Endolumenal Interventional Platform (EIP) Study
A STUDY EVALUATING ENDOSCOPIC PROCEDURE TIME REMOVING COMPLEX COLORECTAL POLYPS SHOWS SUPERIORITY OF DILUMEN OVER CONTROL GROUP. Connecticut-based medical device innovator Lumendi, LLC reports that its 1:1 randomized trial of the DiLumen Endoluminal Interventional Platform (EIP) successfully met the primary endpoint of an IRB-approved 200-patient prospective study. The study ...
By Lumendi Ltd.
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