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
NTT DOCOMO BUSINESS and Chile’s State-owned Copper Company CODELCO Launch a Study and Proof of Concept Aimed at Improving the Efficiency of Remote Copper Mine Operations Using IOWN® APN6.8.2026 06:30:00 CEST | Press release
NTT DOCOMO BUSINESS, Inc. (formerly NTT Communications Corporation) has launched a study and proof of concept jointly with Corporación Nacional del Cobre de Chile (CODELCO) to progress remote operations at CODELCO’s copper mines using an IOWN® All-Photonics Network (APN).1 This initiative is part of a research project commissioned by Japan’s Ministry of Internal Affairs and Communications.2 This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260806845222/en/ Conceptual Diagram of the Demonstration To address operational challenges faced by CODELCO’s copper mines, the initiative will connect a copper mine and a remote operations center—approximately 1,500 km apart—via an IOWN APN. It will assess the feasibility of remotely operating heavy machinery using high-capacity, low-latency communication links, enhancing monitoring operations through high-definition video, and implementing a remote operations model. 1. Background Chile is o
FPT Named an OpenAI Select Partner6.8.2026 02:00:00 CEST | Press release
Global IT corporation FPT today announced that it has been named an OpenAI Select Partner within the OpenAI Partner Network. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260805503787/en/ FPT Named an OpenAI Select Partner The OpenAI Partner Network is a global program for partners to build, sell, and deliver AI solutions with OpenAI. It brings together partners with deep industry expertise, delivery capabilities, and customer relationships while equipping them with resources, enablement, and support to help enterprises adopt OpenAI frontier models and products and turn them into measurable impact. As an OpenAI Select Partner, FPT will continue working with OpenAI to help organizations build, deploy, and scale AI solutions responsibly and effectively. This work will help organizations get more useful work from every token and stronger performance per dollar with GPT‑5.6, while using ChatGPT Work to turn ambitious goals into
U.S. FDA Approves Takeda’s ORZEYFUL™ (oveporexton), the First and Only Medicine to Treat the Underlying Cause of Narcolepsy Type 16.8.2026 00:10:00 CEST | Press release
Adults Taking ORZEYFUL Experienced Significant and Meaningful Improvements Across the Full Range of Symptoms of Narcolepsy Type 1 (NT1) in Clinical Trials Compared to Those on Placebo As a First-in-Class Orexin Treatment, ORZEYFUL has the Potential to Redefine NT1 Care Beyond Individual Symptoms Takeda is Advancing U.S. Launch Preparations and Expects to Make ORZEYFUL Available Following Completion of the Drug Enforcement Administration (DEA) Scheduling Process Takeda (TSE:4502/NYSE:TAK) announced that the U.S. Food and Drug Administration (FDA) approved ORZEYFUL™ (oveporexton), an oral orexin receptor 2 (OX2R) agonist, for the treatment of narcolepsy type 1 (NT1, narcolepsy with cataplexy) in adults.* The persistent 24-hour nature of NT1 is driven by orexin deficiency and can severely impact people’s lives. As a first-in-class orexin treatment, ORZEYFUL is the only medicine indicated in the U.S. to treat the disease holistically rather than individual symptoms. “The FDA approval of OR
Compass Pathways Announces New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)5.8.2026 22:30:00 CEST | Press release
Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to unlocking urgently needed new treatment options in mental health care, announced today that Compass granted equity awards under the Compass Pathways plc 2026 Inducement Plan to fourteen newly hired non-executive employees. The equity awards were granted on August 3, 2026 and consisted of options to purchase an aggregate of 139,355 shares and restricted share units or, in the case of employees in the United Kingdom nominal cost options, covering an aggregate of 66,300 shares. The options have an exercise price per share equal to $11.25, the closing price of the Company’s American Depositary Shares on the Nasdaq Global Select Market on the grant date, and will vest over a four-year period with 25% vesting on the first anniversary of the date of the grant and the remaining 75% vesting in equal monthly installments over the three-year period thereafter, subject to each employee’s continued employment. The restricted
Clinilabs Announces Medical Leadership Appointments5.8.2026 16:05:00 CEST | Press release
Bob Dagher, M.D., Named Chief Medical Officer and Waqar Ahmed Siddiqui, M.D., Named Principal Investigator Clinilabs (“Clinilabs LLC”), a global, full-service contract research organization (CRO) specializing in central nervous system (CNS) drug and device development, today announced the appointments of Bob Dagher, M.D., as Chief Medical Officer and Waqar Ahmed Siddiqui, M.D., as Principal Investigator of the Company’s Eatontown, New Jersey Clinical Research Unit (CRU). Dr. Dagher will provide strategic and medical leadership across the organization, while Dr. Siddiqui will lead the execution of research projects at the Company’s CRU. Together, they will support the design, development, and execution of clinical programs for pharmaceutical, biotechnology, and medical device sponsors advancing innovative therapies for psychiatric, neurological, substance use, and rare CNS disorders. “Clinilabs has earned the trust of sponsors by combining deep scientific expertise, medical leadership,
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