medical product regulatory News
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FDA Will Hold NanoDay Virtual Research Symposium on October 9
The U.S. Food and Drug Administration (FDA) Nanotechnology Task Force is celebrating NanoDay on October 9, 2020, by hosting a virtual research symposium to showcase more than a decade of progress and innovation in nanotechnology at FDA. The agenda lists the following presentations: A Decade of Progress and Innovation in Nanotechnology at U.S. FDA; Considering Whether an FDA-Regulated Product ...
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Orchestra BioMed Enhances Management Team with Appointment of Regulatory Affairs and Combination Product Expert Bob Laughner as Vice President, Regulatory Affairs
Orchestra BioMed, Inc. (“Orchestra BioMed” or the “Company”), a biomedical innovation company developing transformative therapeutic products for large unmet needs in procedure-based medicine, today announced the appointment of Bob Laughner, an expert in global regulatory affairs for combination products, as Vice President, Regulatory Affairs. Mr. Laughner will play a ...
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ODS Medical, Inc. closes a new financing round to further support product development diversification of applications
ODS Medical, Inc., a Montreal based medical technology company, is pleased to announce a new financing round to support product engineering and regulatory work. ODS Medical is bringing together the power of machine learning and molecular imaging to develop optical biopsy tools based on Raman spectroscopy. These tools are bringing real time tissue characterization to operating rooms and diagnostic ...
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Two New Uscom Devices for China
Uscom has completed the development of two new specialised cardiovascular monitors, the “USCOM O2” and the “USCOM Basic”. The development of these two new monitors creates for Uscom a three-tier range of Uscom haemodynamic monitors for sale into China. Uscom is required to obtain regulatory approval of the China National Medical Products Administration (NMPA) for the two ...
By Uscom Ltd
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BioPoly Orthopedic Resurfacing Products Enter North America
FORT WAYNE, IN – BioPoly, LLC has entered into an exclusive distribution agreement with Canada-based distributor, Verve Medical Products, Inc., to distribute the BioPoly® partial resurfacing family of products throughout Canada, with distribution initially taking place through the Canadian SAP. Verve Medical Products specializes in bringing medical-surgical products to Canada through ...
By BioPoly, LLC
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SteriLux has received ISO 13485:2016 certification
We are excited to announce that SteriLux has received ISO 13485:2016 certification for Medical Device and Quality Management Systems from Lloyd’s Register. This ISO certification indicates that the company’s quality management system meets the most current regulatory requirements specific to the medical device industry. “We are very proud to have received this certification ...
By SteriLux SA
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Navient Neuro-navigation System Receives Chinese Regulatory Clearance
ClaroNav Kolahi Inc, a subsidiary of ClaroNav Inc, is pleased to announce that it has received Chinese regulatory clearance from the National Medical Products Administration (NMPA) to market and sell its Navient Cranial model in China. Previously it had received NMPA approval for Navient ENT model. Navient, an image-guided surgical navigation system, is like a GPS for the surgeon to navigate ...
By ClaroNav
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Biotricity CEO, Waqaas Al-Siddiq, to participate in panel discussion on the evolution of medical devices at the American Medical Device Summit on October 19th
Biotricity Inc. (NASDAQ:BTCY) (“Biotricity” or the “Company”), a medical diagnostic and consumer healthcare technology company, today announced that Waqaas Al-Siddiq, Founder and CEO, is scheduled to participate in a panel discussion at the American Medical Device Summit on October 19, 2022 in Chicago, Illinois. American Medical Device Summit: Location: Westin Chicago ...
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LaunchPad Medical Initiates its First European Clinical Study
LaunchPad Medical, Inc. announced that it has received approval from the Medicines and Healthcare products Regulatory Agency in the United Kingdom to start a 15-patient pilot clinical study to examine the safety and efficacy of Tetranite, the company's bone adhesive biomaterial, to immediately stabilize dental implants following tooth extractions. This study will focus specifically on anterior ...
By RevBio Inc.
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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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Cervision™ - First International Sales Launch in Brazil
Spinologics Inc. and Importek have announced today the launch of Cervision™, an upper-extremity patient positioning device for cervical spine surgery, in Brazil. This launch marks the first international sales development of this product since its domestic introduction. “We are pleased to introduce Cervision™ in the Brazilian market”, says Dustin Arless, Director of ...
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BSI launches new CE-Dedicated FastTrack Program at RAPS Conference
BSI, a world-class Notified Body providing regulatory and quality management reviews and product certification for medical devices, today announced the launch of CE-Dedicated FastTrack. This new CE marking program is designed to help medical device manufacturers get their products quickly and safely to European markets. BSI will debut the program at the 2009 Regulatory Affairs Professionals ...
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Proa Medical and Pelv-Ice to Merge
Proa Medical, Inc., the creator of the Brella® Vaginal Retractor, a single-use retractor with a built-in light source designed to provide optimal visualization and access during repair of the vaginal walls and perineum, and other innovative, high potential medical devices for women’s pelvic health, has entered into a Merger Agreement with Pelv-Ice, LLC, the first company formed to ...
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Clip Health™ Expands Company Leadership to Support Innovation Pipeline in Diagnostics-Enabled Decentralized Healthcare
Clip Health, a pioneer in the development of accessible and accurate diagnostics, has made two skilled additions to its leadership team. To continue innovating towards the Company’s product vision of diagnostics-enabled “full stack” healthcare, Clip Health welcomes Maria-Nefeli Tsaloglou, PhD as Vice President of Assay & Product Development, and Cynthia Merrell as Vice ...
By Clip Health
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EMI/RFI: Materials and Technologies - A Comprehensive Market Analysis by BCC Research
Boston: “According to the latest BCC Research study, the demand for EMI/RFI: Materials and Technologies is estimated to increase from $7.4 billion in 2023 to reach $9.2 billion by 2028, at a compound annual growth rate (CAGR) of 4.6% from 2023 through 2028.” This comprehensive report delves into the dynamic landscape of the EMI/RFI materials and technologies market, meticulously ...
By BCC Research
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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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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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The state drug administration issued five medical devices regulations
Recently the state food and drug supervision and administration bureau released five related medical devices regulations come into force as of June this year to the new revision of the regulations on the supervision and administration of medical devices, authorized by the state administration of the in-depth research, many times, on the basis of demonstration, solicit opinions from all sides, and ...
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Thermo Fisher Scientific and Innoforce Partner to Establish Biologics and Steriles Drug Manufacturing Facility in China
Thermo Fisher Scientific Inc. (NYSE:TMO), the world leader in serving science, and Innoforce, a bioinnovation-enabling company, today announced they have signed a joint venture agreement to establish a new pharma services facility in Hangzhou, China, for integrated biologics and steriles drug development and manufacturing. The new facility is expected to be completed in 2022. The new ...
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AventaMed selected as Test Case for RWE by NESTcc
The National Evaluation System for health Technology Coordinating Center (NESTcc), an initiative of the Medical Device Innovation Consortium (MDIC), announces twelve new Test-Cases which leverage Real-World Evidence (RWE) and address key priorities for medical device stakeholders. These Test-Cases are intended to accelerate NESTcc’s progress and provide proof of concept for NESTcc’s ...
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