IVDD

BIO-TECHNE RECEIVES EUROPEAN IVDR CERTIFICATION FOR DIAGNOSTIC TEST TO MONITOR CHRONIC MYELOID LEUKEMIA

Retrieved on: 
Friday, March 22, 2024
Certification, Acute leukemia, Kit, BCR-ABL, Patient, CML, Class, Bio-Techne, Sale, Cancer, IVDR, Diagnosis, Workflow, ABL1, Safety, Liquid biopsy, TKI, Physician, IVDD, Medical device

MINNEAPOLIS, March 22, 2024 /PRNewswire/ -- Bio-Techne Corporation (NASDAQ: TECH) today announced that Asuragen, part of Bio-Techne's Molecular Diagnostics Division, has completed the Class C Certification under the new European Union In Vitro Diagnostic Regulation (IVDR) for its QuantideX® qPCR BCR-ABL IS Kit. Previously, the kit was CE-IVD marked for sale in the EU in compliance with the In Vitro Diagnostic Directive (IVDD), which has now been replaced by the IVDR.

Key Points: 
  • Previously, the kit was CE-IVD marked for sale in the EU in compliance with the In Vitro Diagnostic Directive (IVDD), which has now been replaced by the IVDR.
  • The QuantideX qPCR BCR-ABL IS Kit gives labs a robust and reliable tool for monitoring chronic myeloid leukemia (CML) patients.
  • The highly sensitive qPCR-based in vitro diagnostic test quantifies BCR-ABL1 and ABL1 transcripts in blood samples from patients with CML to determine their response to tyrosine kinase inhibitor (TKI) therapy.
  • CML patients must undergo regular monitoring to ensure that they continue to receive the most appropriate treatment for their cancer.

AliveDx receives IVDR Certification of its Manufacturing Sites in Switzerland and United Kingdom

Retrieved on: 
Monday, November 6, 2023
Certification, Life, IVDR, 2005 in television, EN, Safety, European, Patient, IVDD, Medical device, EU

EYSINS, Switzerland, Nov. 6, 2023 /PRNewswire/ -- AliveDx a global in vitro diagnostics company headquartered in Eysins, Switzerland, today announced it has now received IVDR Certification for both its state-of-the-art manufacturing facilities located in Eysins, Switzerland and Edinburgh, United Kingdom.

Key Points: 
  • EYSINS, Switzerland, Nov. 6, 2023 /PRNewswire/ -- AliveDx a global in vitro diagnostics company headquartered in Eysins, Switzerland, today announced it has now received IVDR Certification for both its state-of-the-art manufacturing facilities located in Eysins, Switzerland and Edinburgh, United Kingdom.
  • AliveDx is proud to announce its manufacturing facilities have been granted In Vitro Diagnostic Regulation (IVDR) certification through EN ISO 13485:2016.
  • It confirms the new and extensive IVDR requirements are met by both AliveDx sites.
  • "The IVDR certification is a significant milestone for our organization.

AliveDx receives IVDR Certification of its Manufacturing Sites in Switzerland and United Kingdom

Retrieved on: 
Monday, November 6, 2023
Certification, Life, IVDR, 2005 in television, EN, Safety, European, Patient, IVDD, Medical device, EU

EYSINS, Switzerland, Nov. 6, 2023 /PRNewswire/ -- AliveDx a global in vitro diagnostics company headquartered in Eysins, Switzerland, today announced it has now received IVDR Certification for both its state-of-the-art manufacturing facilities located in Eysins, Switzerland and Edinburgh, United Kingdom.

Key Points: 
  • EYSINS, Switzerland, Nov. 6, 2023 /PRNewswire/ -- AliveDx a global in vitro diagnostics company headquartered in Eysins, Switzerland, today announced it has now received IVDR Certification for both its state-of-the-art manufacturing facilities located in Eysins, Switzerland and Edinburgh, United Kingdom.
  • AliveDx is proud to announce its manufacturing facilities have been granted In Vitro Diagnostic Regulation (IVDR) certification through EN ISO 13485:2016.
  • It confirms the new and extensive IVDR requirements are met by both AliveDx sites.
  • "The IVDR certification is a significant milestone for our organization.

DoMore Diagnostics And Proscia Partner To Inform Personalized Treatment Decisions For Colorectal Cancer Patients

Retrieved on: 
Wednesday, August 30, 2023
Laboratory, Partnership, IVDR, CRC, IVDD, Deep learning, Marie Cassidy, Intelligence, Large intestine, II, Congress, Rollcage Stage II, Hospital, MD, Patient, Colorectal cancer, European, Neoplasm, Ecosystem, Research, Lancet, III, Disease, Medical imaging, Medical device, EU, Pathology

OSLO and PHILADELPHIA, Aug. 30, 2023 /PRNewswire-PRWeb/ -- DoMore Diagnostics, a leader in deep learning precision diagnostics for digital pathology, and Proscia®, a leading provider of digital and computational pathology solutions, have partnered to help pathologists predict outcomes for colorectal cancer (CRC) patients. The collaboration paves the way for integrating artificial intelligence (AI)-powered clinical decision support into routine pathology workflows, unlocking new insights that can guide increasingly precise treatment decisions and ensure patients receive optimal care.

Key Points: 
  • "We look forward to adding Histotype Px Colorectal to our ecosystem to help Proscia users make increasingly personalized diagnoses that can ultimately reduce overtreatment for more patients."
  • - Stephan Fromme, Proscia's Head of Strategic Alliances
    CRC is the third most common and second most deadly cancer worldwide[1].
  • "We have proven that Histotype Px Colorectal can offer valuable insight to guide personalized treatment decisions and help improve patient outcomes," said Torbjørn Furuseth, MD, CEO and Co-founder of DoMore Diagnostics.
  • We look forward to adding Histotype Px Colorectal to our ecosystem to help our users make increasingly personalized diagnoses that can ultimately reduce overtreatment for more patients."

AI Diagnostic Platform Company Noul Releases 2022-2023 Sustainability Report

Retrieved on: 
Tuesday, June 27, 2023
CE, Communication, IVDD, Sound, Sustainability reporting, Policy, Research, Organization, Government degree colleges in India, DART, Philosophy, KOSDAQ, Korea Human Rights Foundation, Ethics, Acquisition, Platform, Risk management, Artificial intelligence, Growth, Value, Malaria, Management, Health care, Typhoon Noul (2015)

YONGIN, South Korea, June 27, 2023 /PRNewswire/ -- Noul Co., Ltd., (376930.KR), an Artificial Intelligence (AI) based decentralized diagnostic platform company, has released its 2022-2023 Sustainability Report, including corporate efforts and achievements in implementing sustainability.

Key Points: 
  • YONGIN, South Korea, June 27, 2023 /PRNewswire/ -- Noul Co., Ltd., (376930.KR), an Artificial Intelligence (AI) based decentralized diagnostic platform company, has released its 2022-2023 Sustainability Report, including corporate efforts and achievements in implementing sustainability.
  • Noul has also self-disclosed the report to the DART electronic disclosure system on July 27.
  • Since 2020, Noul has issued a sustainability report every year, transparently disclosing to the stakeholders corporate activities and performances in the economic, social and environmental sector according to the company's growth stage.
  • By disclosing annual sustainability improvement plans and implementation results through sustainability report, Noul also strives to communicate responsibly with stakeholders, including investors, shareholders, customers, cooperative partners, and employees, who are participating in Noul's mission.

Revvity’s EUROIMMUN Spearheads Cutting-Edge Diagnostic Analysis with New Automated IIFT System

Retrieved on: 
Thursday, June 1, 2023
Medical Devices, Health, Research, Pharmaceutical, Science, Biotechnology, CE, EU, IVDD, Acquisition, Laboratory, Autoimmune disease, Diagnostic medical sonography, European, Glass, NYSE, Safety, Medical device

Revvity, Inc. (NYSE: RVTY), announced today that its EUROIMMUN business has launched the UNIQO 160 (CE-IVDR), an automated indirect immunofluorescence test (IIFT) system for autoimmune disease diagnostics.

Key Points: 
  • Revvity, Inc. (NYSE: RVTY), announced today that its EUROIMMUN business has launched the UNIQO 160 (CE-IVDR), an automated indirect immunofluorescence test (IIFT) system for autoimmune disease diagnostics.
  • “Traditional IIFT processing can be tedious and time-consuming, requiring the expertise of specially trained lab technicians and a dark room,” said Dr. Bianca Huth, chief technology officer of EUROIMMUN.
  • In May 2023, EUROIMMUN received its certificate of compliance with the European In Vitro Diagnostic Medical Device Regulation (EU IVDR).
  • To learn more about these and other EUROIMMUN automated IFA solutions, visit this webpage .

Deep Breath Intelligence Teams with HTEC Group and Effectum Medical to Accelerate the Launch of CE-marked device under IVDD

Retrieved on: 
Thursday, May 25, 2023
Intelligence, CE, Partnership, IVDD, DBI, Valproate, Documentation, Machine learning, Association of British HealthTech Industries, Medtech, Software, Medical device

DBI-EPIbreath® is a unique easy-to-apply breath test that can provide reliable estimates of circulating concentrations of the antiseizure medication valproic acid to aid patient management.

Key Points: 
  • DBI-EPIbreath® is a unique easy-to-apply breath test that can provide reliable estimates of circulating concentrations of the antiseizure medication valproic acid to aid patient management.
  • Considering a very strict regulatory deadline that Deep Breath Intelligence had to meet to make DBI-EPIbreath® compliant, they approached HTEC to help them speed up their product launch considering regulatory requirements of IVDD in conjunction with Effectum Medical AG, the official legal manufacturer of the medical device.
  • "Every medical venture or initiative would like a speedy launch, but only the right skill set and partnership with a client can deliver.
  • Karina Candrian, CEO of Effectum Medical, said: "The project with DBI and HTECH is a great proof of our vision, 'We make innovation happen!'

Global Biomarkers Markets, 2017-2021 & 2022-2028: A Highly Competitive Market with 800+ Players - Niche Players Control About ~77% of the Market - ResearchAndMarkets.com

Retrieved on: 
Tuesday, May 9, 2023
Health, Other Health, Prevalence, IVDD, Abbott Laboratories, Prognosis, Key, Privacy, Bangladesh Technical Education Board, App Store (iOS/iPadOS), Plasma, COVID-19, Thermo Fisher Scientific, Patient, Investment, Merck, Database, General Electric, Therapy, Heart failure, Disease, NGS, SARS-CoV-2, Risk, USD, Biomarker, Medicine, Diagnosis, Growth, Acute respiratory distress syndrome, Death, BD, DNA, FNIH, Roche, Qiagen, Algorithm, Johnson & Johnson, Epigenomics AG, DHT, Bristol Myers Squibb, RNA, Novartis, PerkinElmer, Artificial intelligence, AI, FTD, Pfizer, Video game, Generic drug, Vaccine, Medical device, Pharmaceutical industry, Fine chemical, Oil, Neurodegenerative disease

The growing popularity of remote technologies such as wearables and mobile applications is fuelling the digital biomarker market (DBMs) growth.

Key Points: 
  • The growing popularity of remote technologies such as wearables and mobile applications is fuelling the digital biomarker market (DBMs) growth.
  • Country-Niche players control about ~77% of the market, while regional players hold a share of ~18%.
  • Though the market is highly competitive with over ~800 participants, few country-niche players control the dominant share.
  • The Global Biomarkers Market is covered from 2017-2028 in this report, which includes a forecast for the period 2022-2028
    What is the Future Growth Rate of the Global Biomarkers Market?

QIAGEN’s tuberculosis blood test QuantiFERON-TB Gold Plus gains CE-marking under new EU IVDR framework

Retrieved on: 
Tuesday, February 14, 2023
Biotechnology, Medical Devices, Health, Genetics, Pharmaceutical, Gold, QIAGEN, Diagnosis, Tuberculosis, NYSE, IVDR, Patient, IVDD, Certification, Senior, Notified body, QFT, WHO, QGEN, IVD, EC, FDA, Bacteria, TB, JAK2, Medical device, EU, European

QFT-Plus is QIAGEN’s trusted test, endorsed by the WHO, that aids in indirect detection of the bacteria that causes tuberculosis (TB).

Key Points: 
  • QFT-Plus is QIAGEN’s trusted test, endorsed by the WHO, that aids in indirect detection of the bacteria that causes tuberculosis (TB).
  • The IVDR certification of QFT-Plus follows the QIAGEN ipsogen JAK2 RGQ PCR Kit as well as the NeuMoDx Systems and reagents, which gained IVDR CE-marking in late 2022.
  • “Our teams have been able to demonstrate that QuantiFERON-TB Gold Plus is compliant to the IVDR requirements through stringent regulatory review.
  • For more information about the transition from IVDD to IVDR and the corresponding time frame, please visit the IVDR support site .

Global and Regional Next-Generation Sequencing (NGS) Informatics Market Report 2022-2032: Burgeoning Opportunities in the Evolving Regulatory Landscape for Clinical NGS - ResearchAndMarkets.com

Retrieved on: 
Wednesday, February 1, 2023
Health, Genetics, Biotechnology, Laboratory, Government, Thermo Fisher Scientific, Korea Disease Control and Prevention Agency, SPHERES, NGS, Cancer, Informatics, Patient, Region, IVDD, Research, CDC, SAML-based products and services, Conditional sentence, COVID-19, Name, Strengthening Public Health Emergency Response Act of 2015, Software, Vaccine, Medical device, Epidemiology

The global NGS informatics market was valued at $1,380.0 million in 2021 and is projected to reach $6,715.0 million by the end of 2032.

Key Points: 
  • The global NGS informatics market was valued at $1,380.0 million in 2021 and is projected to reach $6,715.0 million by the end of 2032.
  • The evolving regulatory landscape for clinical NGS and the growing number of gene mutations across various diseases are some of the major opportunities in the global NGS informatics market.
  • Application: The global NGS informatics market (by application) is expected to be dominated by the genetic screening segment.
  • End User: The global NGS informatics market (by end user) is dominated by the pharmaceutical and biotechnology companies segment.