Healthcare Industry News: apixaban
News Release - May 7, 2021
Perosphere Technologies Announces CE-IVD Marking of the Perosphere Technologies PoC Coagulometer System for DOAC and Heparin TestingDANBURY, Conn., May 7, 2021 -- (Healthcare Sales & Marketing Network) -- Perosphere Technologies Inc. today announced CE (Conformité Européene)-IVD Marking of its Point-of-Care (PoC) Coagulometer System. The CE Mark confirms that the Company's PoC Coagulometer System meets the safety requirements of the European In-Vitro Diagnostic Devices Directive (98/79/EC) and allows Perosphere Technologies to begin commercialization of its products throughout the European Union and other CE Mark geographies.
Worldwide, approximately 1 million DOAC patients annually present to the emergency department with severe bleeding (e.g. gastrointestinal bleeding or intracranial hemorrhage) or requiring emergency surgery. Globally, the "high risk" DOAC and LWWH patient populations are approximately 5 million and 3 million patients annually, respectively, representing those individuals with conditions such as renal or hepatic insufficiency, low BMI, or a history of major bleeding or thrombosis for whom measuring WBCT at intervals could improve quality of care.
"We are excited to offer healthcare providers in the EU and other international markets a first-in-class solution for DOAC and low molecular weight heparin coagulation testing at the point of care," said Dr. Sasha Bakhru, CEO of Perosphere Technologies. "We believe our PoC Coagulometer system will change the paradigm for managing DOAC and heparin therapy in emergency settings and beyond."
Perosphere Technologies plans to launch the PoC Coagulometer system in select EU countries later this year, with an expanded launch planned for early Q1 2022. If you are interested in learning more about the PoC Coagulometer, please contact us at EUsales@perospheretech.com or by phone at +1 (475) 218-4600.
About Perosphere Technologies
Perosphere Technologies is a private medical technologies company, focused on the development and commercialization of a novel Point-of-Care (PoC) coagulometer technology platform. For further information, contact us at email@example.com or +1 (475) 218-4600.
Source: Perosphere Technologies
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