Medical Device Regulations News
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CELLINK Announces CELLINK Vivoink: Our First Medical-Grade Bioink
CELLINK, a global leader in bioprinting technologies, is proud to announce a pioneering innovation in the field of regenerative medicine and tissue engineering with the launch of CELLINK Vivoink, the first-ever medical-grade bioink specially designed to support researchers on their clinical translational journey. CELLINK Vivoink is optimized for superior printability, mechanical stability, and ...
By CELLINK
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FDA Establishes New Medical Device Category: FDA Authorization Now Required to Market UV Robots to Healthcare Facilities
The U.S. Food and Drug Administration (“FDA”) has announced a new medical device product classification “whole room microbial reduction device” which establishes FDA regulation of UV robots intended to reduce the number of pathogens in unoccupied patient rooms, operating rooms and other areas in healthcare facilities where non-critical medical devices are present. ...
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FARCO-PHARMA initiates sales in the U.S.
The U.S. Food and Drug Administration recently completed its regulatory inspection of the production site in Berlin and issued FARCO-PHARMA approval for the marketing of a sterile lubricant in disposable syringes in the United States. FARCO-PHARMA has been producing and selling the sterile catheter lubricant under the brand name GLYDO® on the U.S. market since October 2014. Medicinal ...
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Is data drift an issue for medical AI models - and what can we do about it?
While medical AI has many potential benefits, there are challenges that have not been tackled yet. One of the major challenges is the limited generalizability of many AI algorithms. Applying a medical AI algorithm that is trained in hospital A may give unexpected results when applied in hospital B. Why does this happen? Certain parameters are different between hospitals. If hospital A has Siemens ...
By Segmed, Inc.
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Portal Instruments appoints Dr. Veena Rao, PhD, as Chief Business Officer
Portal Instruments is pleased to announce the appointment of Dr. Veena Rao, PhD, as Chief Business Officer, effective December 5th, 2022. Dr. Rao will lead the identification, evaluation, and negotiation of partnership opportunities for Portal. In addition, Dr. Rao, in close collaboration with the CEO and cross-functional team, will guide the company’s short and long-term commercial ...
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Materials and application methods of disinfection and sterilization packaging
Paper or plastic "has a new meaning when it is related to the disinfection of instruments in dental clinics. As a medical device, there are strict standards for the production of sterilization packaging. Disinfection and sterilization bags are usually made of paper and plastic and are a key component of any sterility assurance. The goal of the dental infection control program is to reduce the ...
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VIDA receives 510(k) clearance for deep learning-based enhancements to its LungPrint solution
VIDA Diagnostics, Inc. (“VIDA”), the leader in lung and respiratory intelligence, announced today that it has received 510(k) clearance from the Food and Drug Administration (FDA) for enhancements to its LungPrint solution, including automated deep learning-based lung and lobe segmentation algorithms. This clearance further validates the quality and clinical efficacy of the ...
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Imricor Submits for Approval to Commence VT Trial in Europe
Imricor Medical Systems, Inc. (Company or Imricor) (ASX:IMR), the global leader in real-time iCMR cardiac ablation products, is pleased to announce that the Company has submitted for approval to commence a real-time iCMR-guided ventricular tachycardia (VT) ablation clinical trial. The name of the study is “Vision-MR Ablation of VT” or VISABL-VT. VISABL-VT is a prospective, ...
By Imricor
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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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Senstech AG becomes part of the IST Group
Senstech sensors can be found in a variety of applications in the medical field, such as infusion or insulin pumps, in cardiotocography or in devices for eye surgery. Other important areas of application are textile machinery, mechanical engineering, the watch industry, industrial pressure measurement technology, and applications for cars. In addition to OEM sensor solutions the company also ...
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Turning a Great Idea into a Successful Product: ASPIRE
For VisionQuest’s vice president and principal investigator Vinayak Joshi (PhD), the journey from idea to commercial product has led him halfway around the world. Dr. Joshi recently traveled to Malawi, Kenya, Nigeria, and Ghana as part of his efforts to commercialize ASPIRE, his device for the detection and diagnosis of malarial retinopathy. While in Africa, he met with leaders in ...
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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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Neuros Medical Announces Completion of QUEST Pivotal Trial 90-day Primary Endpoints
Neuros Medical, Inc., a medical device company developing an innovative, on-demand bioelectric nerve block therapy for patients with intractable post-amputation pain, announced today the completion of its QUEST Pivotal Trial 90-day primary endpoints. QUEST outcomes will remain blinded through the 12-month follow-up period, per protocol. QUEST is a 180-subject randomized, double blinded, active ...
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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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STEMart Introduces Biocompatibility Evaluation of Breathing Gas Pathways in Medical Devices
STEMart, a provider of integrated medical device CRO services dedicated to medical device and diagnostic clinical development, expands its Biocompatibility Testing services and introduces biocompatibility evaluation of breathing gas pathways in medical devices. This new testing follows the biocompatibility guidelines modified for medical devices and uses a solid scientific rationale. ...
By STEMart
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enVVeno Medical Reports Fourth Quarter and Year-End 2021 Financial Results and Provides Corporate Update
Ended the Year With $55 Million in Cash Expected To Fund Operations Through the End of 2024 Including Release of Topline Pivotal Trial Data Nine (9) VenoValve Surgeries Successfully Completed and 16 Clinical Sites Currently Active in Ongoing SAVVE U.S Pivotal Trial Continued Advancement in Development of Second Device for the Treatment of Venous Disease Expected To Be Unveiled in Mid-2022 ...
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STEMart Launches Pyrogenicity Testing Service for Medical Devices
STEMart, a provider of integrated medical device CRO services dedicated to medical device and diagnostic clinical development, now launches Pyrogenicity Testing service for the medical device industry. This new testing follows the biocompatibility guidelines modified for medical devices. Due to the risks associated with medical devices, comprehensive medical device testing throughout the product ...
By STEMart
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Excite Medical participates in successful trade mission to Ecuador
Excite Medical, the maker of the revolutionary DRX9000™ spinal decompression machine, participated in a successful trade mission to Quito, Ecuador April 4–7, facilitated by Enterprise Florida. “It was an honor to participate in this trade mission to Ecuador, meet leaders and executives, and help spread the word about non-surgical, drug-free treatments for low back pain,” ...
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ISO 13485 Audit Passed 2022
Cryptych P/L, Vestech’s sister company, recently passed its annual ISO 13485 audit, carried out by notified body BSi. This pass was a significant milestone and the fact that there were no non-conformances is an outstanding achievement by the whole of the Vestech team. Vestech’s experience with maintaining ISO13485 (for CE Marking and Australian compliance), as well as CFR21 for FDA ...
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CathWorks and Quest International Announce Global Post-Sales Technical Service Support Partnership
CathWorks, an original equipment manufacturer (OEM), and Quest International, a global service support provider to the OEMs, announced today they have signed a post-sales technical service support agreement that Quest International becomes the preferred technical service delivery partner for end-to-end service support of CathWorks’ fast-growing install-base of customers globally. CathWorks ...
By CathWorks
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