CIBILTECH
30.6.2021 09:02:13 CEST | Business Wire | Press release
Predigraft, Cibiltech's first medical device, a software predicting individual long-term kidney allograft survival and improving the management of transplant patients, was granted CE Marking on June 23, 2021.
Hélène VIATGE, Cibiltech's Managing Director, said: "Predigraft's CE marking is a major milestone for Cibiltech and I am very proud to announce that Cibiltech is the first French company to have officially received class IIa marking under the new regulation for a 100% digital solution. Software such as Predigraft are now considered as medical devices with the same standards and quality requirements, for the benefit of patients and healthcare professionals. The work conducted by Manon MARAULT, our Quality and Regulatory Manager, and her team is colossal and this recognition by our notified body undoubtedly opens a very promising new chapter for the company."
The CE marking allows the company to market its medical device in all countries that recognize this certification, including all countries of the European Union.
Predigraft: Predigraft was created based on the iBox technology, an algorithm developed by the Paris Transplant Group (INSERM UMR 970 / AP-HP / University of Paris), which gives the probability that the graft will still be functional at 3, 5 and 7 years after evaluation by the healthcare professional.
About Cibiltech: Cibiltech is a pioneer in the development of artificial intelligence-based software medical devices, offering its solutions to patients, healthcare professionals and to the pharmaceutical industry. Cibiltech's ambition is to build the distribution platform for algorithms to prevent organ failures. Cibiltech's expertise in the regulatory, clinical and infrastructure aspects of digital health solutions places it in a unique position to achieve this goal.
For more information: www.cibiltech.com
View source version on businesswire.com: https://www.businesswire.com/news/home/20210630005058/en/
Link:
About Business Wire
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
Quectel SP900BF-AP Smart Module Sets the Pace for Edge AI with 100 TOPS of Computing Power11.11.2026 10:00:00 CET | Press release
Quectel Wireless Solutions, a global end-to-end IoT solutions provider, today announced the SP900BF-AP, a smart module that lets robots, inspection systems and edge gateways run large AI models on the device itself. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261111252890/en/ Quectel SP900BF-AP smart module sets the pace for Edge AI with 100 TOPS of computing power Built on the Qualcomm Dragonwing™ IQ-9075 Processor and delivering up to 100 TOPS of on-device AI compute, the module enables industrial OEMs to integrate advanced AI directly into their products, reducing latency, bandwidth costs and data privacy risks associated with cloud-based processing. By processing data locally, manufacturers can support real-time robotics, automated inspection and other demanding industrial applications while retaining greater control over sensitive production data. Long-term hardware availability also helps meet the extended product l
Quectel Expands 5G Antenna Portfolio With Ten Versatile Combo Solutions, From Compact 2-In-1 to Rugged 9-In-1 Designs11.11.2026 10:00:00 CET | Press release
Quectel Wireless Solutions, a global IoT solutions provider, today announces ten external combo antennas that combine 5G with GNSS, Wi-Fi or both in a single housing. Instead of specifying, fitting and testing a separate antenna for each radio, device makers can choose one unit matched to the size, technology mix and operating environment of their deployment. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261111461614/en/ Quectel expands 5G antenna portfolio with ten versatile combo solutions, from compact 2-in-1 to rugged 9-in-1 designs Across the family, each antenna combines multiple omnidirectional elements with high isolation between them to limit self-interference. Most models cover 5G from 600MHz to 6000MHz and remain backward compatible with 4G, 3G, 2G, LTE Cat-M and NB-IoT networks. All support screw mounting, some also adhesive mounting, and housings are built for outdoor use with ratings from IP65 up to IP69K. “Ev
Lattice and NXP Deliver Flexible, Secure Computing Solution for the Industrial Edge10.11.2026 22:00:00 CET | Press release
Lattice Semiconductor (NASDAQ: LSCC), the low power programmable and platform firmware leader, today announced the Lattice NXP PCIe® Companion solution, jointly enabled and promoted with NXP® Semiconductors. Pairing NXP’s i.MX 95 applications processor with Lattice Nexus™-based FPGAs over PCIe, the solution addresses the real-time connectivity, deterministic I/O, and security challenges in industrial automation, robotics, and intelligent edge applications. The joint solution is available in Lattice CertusPro™-NX or Lattice Certus™-NX configurations as companion chips to NXP i.MX 95 SoC compute processors, deepening a long-standing collaboration between Lattice and NXP spanning industrial, data center, and networking applications. The Lattice FPGA adds low latency, deterministic I/O alongside the NXP applications processor, delivering combined capabilities across real-time processing, AI, and custom I/O to help customers modernize aging designs for new interface standards. It supports e
FDA Approves PIMJETMI® (pimicotinib) for Patients with Tenosynovial Giant Cell Tumor10.11.2026 19:14:00 CET | Press release
PIMJETMI is a new once-daily oral systemic treatment option for certain U.S. patients with symptomatic tenosynovial giant cell tumor (TGCT)In the Phase 3 MANEUVER trial, PIMJETMI demonstrated early1 and durable2 tumor response with clinically meaningful improvements in all clinical outcome assessments, including physical function and painPIMJETMI has shown high objective response rate (ORR) with a manageable safety profileNot intended for Canada-, UK- or US-based media Merck, a leading science and technology company, announced today that the U.S. Food and Drug Administration (FDA) has approved PIMJETMI® (pimicotinib), a once-daily oral colony stimulating factor-1 receptor (CSF-1R) inhibitor, as a systemic treatment for adults with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection may cause worsening functional limitation or severe morbidity. “People living with TGCT have long faced difficult treatment decisions as they navigate a disease that can significant
Smartsheet Integrates With Claude Sheets, Making It Easy to Start Projects in Claude and Launch Workflows Across Teams with Smartsheet10.11.2026 18:57:00 CET | Press release
New Send to Smartsheet feature moves work started in Claude into Smartsheet, where the Execution Graph connects it to the people, plans and goals that see it through Smartsheet, the AI-powered enterprise work management platform, today announced a new integration with Claude Sheets, the new spreadsheet artifact in Claude from Anthropic, now in beta. With the new Send to Smartsheet feature, people who build a tracker or plan in Claude can move it into Smartsheet in a few clicks. There they can put it to work with their team, connected to the plans, projects, people and systems their organization already runs on. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261110763156/en/ With the new Send to Smartsheet feature, people who build a tracker or plan in Claude can move it into Smartsheet in a few clicks. More and more work now begins in a conversation with Claude, and the Smartsheet MCP connector for Claude puts the entire pow
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