T-TAS Product Commercialization and Sales Launch
First written in FY2016. 4 of 9 entries say "Restated". Latest entry: FY2025.
0 other companies' latest entry also says "Restated".
- FY2025RestatedAnnual report
「In the in-vitro diagnostic and medical-device fields, we are also strengthening the global rollout of the T-TAS® thrombogenicity analysis system, and its use in clinical testing is gradually increasing.」
The stronger global rollout of T-TAS and increased use in clinical testing were reconfirmed. - FY2024AdvancedAnnual report
「We are also strengthening the global rollout of the T-TAS® thrombogenicity analysis system, and its use in clinical testing is gradually increasing.」
At the stage following the European launch and US FDA approval, the company reported stronger global rollout of T-TAS and increased use in clinical testing. - FY2023RestatedAnnual report
「In advanced medicine, we are developing the T-TAS® 01 thrombogenicity analysis system as a medical device. After completing CE marking registration in Europe in May 2019, we launched it there. In February 2020, we obtained medical-device approval from the US FDA and launched the product in the United States. Development of follow-on products for T-TAS® 01 is also progressing in parallel as we work to expand the surrounding product lineup.」
The previous progress of a European launch, US FDA approval and follow-on product development was reconfirmed. - FY2021RestatedAnnual report
「In advanced medicine, we are developing the T-TAS® 01 thrombogenicity analysis system as a medical device. After completing CE marking registration in Europe in May 2019, we launched it there. In February 2020, we obtained medical-device approval from the US FDA and launched the product in the United States. Development of follow-on products for T-TAS® 01 is also progressing in parallel as we work to expand the surrounding product lineup.」
The annual report reconfirmed the previous progress, namely the European launch, US FDA approval and development of follow-on products. - FY2020AdvancedAnnual report
「We are developing the T-TAS® 01 thrombogenicity measurement system as a medical device, launched it in Europe in May 2019, and obtained medical-device approval from the US FDA in February 2020. Development of follow-on T-TAS® products is also progressing in parallel as we work to expand the surrounding product lineup.」
T-TAS 01 progressed to its launch in Europe in May 2019 and receipt of US FDA medical-device approval in February 2020. Development of follow-on products is continuing. - FY2019RestatedAnnual report
「We are advancing development to bring the T-TAS® thrombogenicity monitoring and measurement system, launched as a research instrument in 2015, to market as a medical device for diagnostic use.」
Development of T-TAS as a diagnostic device continues, but no new registration deadline or completion is stated. - FY2018SoftenedAnnual report
「We are advancing development to bring the T-TAS® thrombogenicity monitoring and measurement system, launched as a research instrument in 2015, to market as a medical device for diagnostic use.」
Development toward medical-device use continues, but the previously stated target of registration in fiscal 2018 is not mentioned this time. - FY2017AdvancedAnnual report
「The T-TAS® thrombogenicity monitoring and measurement system was launched as a research instrument in the previous fiscal year. Development as a medical device for diagnostic use remains ongoing, with registration as a medical device targeted for fiscal 2018. In parallel, we are developing follow-on products for T-TAS® to expand our medical-device lineup and the scope of diagnostic applications.」
Following the launch as a research instrument, the company set a time-bound target of medical-device registration in fiscal 2018 and announced the development of follow-on products. - FY2016First statedAnnual report
「We completed the thrombogenicity analysis system T-TAS and began selling it in Japan, the United States and Europe as a research instrument in October 2015. We are continuing to develop the system as a medical device for diagnostic use.」
Sales began in Japan, the United States and Europe as a research instrument, and development as a diagnostic device continued.