Thermo Fisher Scientific Certifies Applied Biosystems QuantStudio 7 Pro Dx Real-Time PCR System to Meet IVDR Requirements
12.9.2022 09:30:00 EEST | Business Wire | Press release
Thermo Fisher Scientific has certified the Applied Biosystems QuantStudio 7 Pro Dx Real-Time PCR System* to meet new In Vitro Medical Devices Regulation (IVDR) requirements. The updated system now includes new, complementary Applied Biosystems Diomni Software ecosystem to empower clinical labs and test developers to leverage flexible PCR testing onsite.
Designed for maximum productivity and fast ramp-up, the QuantStudio 7 Pro Dx Real-Time PCR System enables users to transition from development to validation on a single system. The expandable, automated platform comes with interchangeable 96-well and 384-well blocks and also includes remote desktop and touchscreen controls, facial authentication, voice command and smart tech support to increase user productivity.
“We have continued to support our customers throughout the transition to IVDR, first by introducing the updated Applied Biosystems QuantStudio 5 Dx Real-Time PCR System earlier this year and now with the launch of the IVDR-compliant QuantStudio 7 Pro Dx Real-Time PCR System and new complementary Diomni Software ecosystem,” said Fernando Beils, vice president and general manager of qPCR instruments at Thermo Fisher Scientific. “As test developers and laboratories expand their assay menus and IVD testing capabilities, we are committed to continue providing innovative solutions to meet their evolving needs.”
Whether performing a routine test or developing a new assay, the integrated, IVDR-compliant Applied Biosystems Diomni Software ecosystem is designed to streamline the entire workflow with a plug-and-play design and simplified set-up to enhance efficiency and minimize user error. The centralized set-up allows connection to multiple real-time PCR instruments and secure data sharing across a user network.
“The ability to import plate set-up files from external software and export result sets in a customizable structure made it easy to integrate the QuantStudio 7 Pro Dx Real-Time PCR System with our laboratory information management software,” said Dr. Gustav Quade, laboratory medicine and technical development specialist at the Quade Laboratory in Germany. “The new Diomni Software makes it easy to work collaboratively and we can set up runs, manage past runs and documentation, and interpret fluorescent curves remotely and efficiently without the need to install special software.”
The QuantStudio 7 Pro Dx Real-Time PCR System is available in all regions that recognize CE-IVD certification and is also listed with the U.S. Food and Drug Administration (FDA) as a class II medical device.
For more information, please visit www.thermofisher.com/quantstudio7prodx.
*The QuantStudio 7 Pro Dx Real-Time PCR System is For In Vitro Diagnostic Use.
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.
For more information, please visit www.thermofisher.com
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220911005026/en/
Contact information
Media Contact Information:
Mauricio Minotta
Phone: 760-805-5266
Email: mauricio.minotta@thermofisher.com
Jennifer Heady
Phone: 413-237-5141
Email: jheady@greenough.biz
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Carta Rearchitects Private Capital Operations with Plugins for Claude29.7.2026 17:01:00 EEST | Press release
Carta, the connected platform and AI-native ecosystem for private capital, today announces broad availability of its suite of Plugins for Claude following the initial launch in April 2026. With more than 1,500 companies and firms already using the plugins, Carta is changing the way private capital teams — from founders to CFOs — fundamentally operate, bringing fund administration, cap table management, and dealflow analytics directly into the spreadsheets, presentations, and workflows they already use every day. "For the last decade, private capital operation teams have been held back by a hidden tax: the constant, manual handoff of data between disconnected systems," said Henry Ward, Carta CEO. "Carta is eliminating that broken loop entirely by embedding intelligence directly into the tools teams already use. We are not waiting for an AI-native future for private capital — it is running on Carta today." Carta didn't just give Claude a pipe to its data. Carta built its private-capital
VDyne Announces First Patient Treated in TRIVITA US IDE Pivotal Study of the TriNova™ Transcatheter Tricuspid Valve Replacement System29.7.2026 16:00:00 EEST | Press release
VDyne Inc. (“VDyne”), a privately held medical device company developing an innovative transcatheter tricuspid valve replacement (TTVR) system, today announced that the first patient has been enrolled and treated in the TRIVITA US IDE pivotal study of the TriNova™ system. The randomized controlled study will compare TriNova head-to-head with the commercially available Edwards EVOQUE™ TTVR system. The TRIVITA trial (NCT07516444) initiation marks a significant milestone in advancing treatment for tricuspid regurgitation (TR). The prospective, global, multicenter, randomized (1:1) controlled study is designed to evaluate the safety and effectiveness of the TriNova TTVR system in patients with severe or greater tricuspid regurgitation who are suitable for valve replacement. The study will be conducted in the US and Europe with up to 70 sites participating. The first patient was enrolled at the Allina Health Minneapolis Heart Institute at Abbott Northwestern Hospital in Minneapolis, and tre
Grid Dynamics Accelerates Enterprise AI-Native Transformation With Workforce Certification and GAIN Platforms Rollout29.7.2026 16:00:00 EEST | Press release
Grid Dynamics Holdings, Inc. (Nasdaq: GDYN) (“Grid Dynamics”), a leading provider of technology consulting, platform and product engineering, and AI-driven digital transformation services, today announced significant momentum in the adoption of its enterprise agentic AI solutions. Organizations across retail, financial services, manufacturing, CPG, and logistics industries are increasingly deploying Grid Dynamics’ agentic AI-native platforms and Forward Deployed Engineering (FDE)-led services to accelerate software delivery, improve operational efficiency, and transform business processes at scale. Grid Dynamics is widely recognized for its enterprise AI expertise and delivery capabilities across Fortune 1000 organizations. Grid Dynamics has partnership agreements with Anthropic and OpenAI to accelerate the adoption of these platforms within enterprises. By the end of October 2026, Grid Dynamics plans to have 90% of its engineers trained and certified on these platforms. Built to suppo
VDyne Announces First Patient Treated in TRIVITA US IDE Pivotal Study of the TriNova™ Transcatheter Tricuspid Valve Replacement System29.7.2026 16:00:00 EEST | Press release
VDyne Inc. (“VDyne”), a privately held medical device company developing an innovative transcatheter tricuspid valve replacement (TTVR) system, today announced that the first patient has been enrolled and treated in the TRIVITA US IDE pivotal study of the TriNova™ system. The randomized controlled study will compare TriNova head-to-head with the commercially available Edwards EVOQUE™ TTVR system. The TRIVITA trial (NCT07516444) initiation marks a significant milestone in advancing treatment for tricuspid regurgitation (TR). The prospective, global, multicenter, randomized (1:1) controlled study is designed to evaluate the safety and effectiveness of the TriNova TTVR system in patients with severe or greater tricuspid regurgitation who are suitable for valve replacement. The study will be conducted in the US and Europe with up to 70 sites participating. The first patient was enrolled at the Allina Health Minneapolis Heart Institute at Abbott Northwestern Hospital in Minneapolis, and tre
Experian Recognized by Chartis Research for Advancing AI Model Governance in Quantitative Analytics50 202629.7.2026 16:00:00 EEST | Press release
Experian today announced it has been recognized by Chartis Research as the winner in the Model Risk Management Environment category in the Quantitative Analytics50 2026 report. The recognition marks Experian's first appearance in the prestigious ranking and reinforces the company's position as a leading provider of data and AI-driven analytics solutions for regulated financial services organizations. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260729058148/en/ Chartis Research recognized Experian as the category winner for Model Risk Management Environment in the Quantitative Analytics50 2026 report. "This recognition from Chartis reflects the growing importance of governing AI with the same rigor used to build it," said Vijay Mehta, Chief AI Officer at Experian. "Financial institutions need to scale AI without sacrificing transparency, accountability or regulatory compliance. Our vision is to provide an integrated agenti
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom