INTERCEPT Blood System Kit Shipments Surpass 7.5 Million Treatable Platelet and Plasma Doses Since Launch

mJOULE Launches in the United Kingdom Reports Sciton

"Sciton is dedicated to worldwide support and growth. We continue to demonstrate our commitment to developing high quality devices and marketing efforts for our physician and medspa partners worldwide." says Lacee J. Naik, Vice President of Marketing and Public Relations.

FDA Issues Draft Guidance on Remanufacturing and Discussion Paper Seeking Feedback on Cybersecurity Servicing of Medical Devices

With this in mind, the FDA is issuing today's draft guidance to help clarify whether activities performed on medical devices are likely remanufacturing as well as a discussion paper on cybersecurity servicing of devices.

Irrimax Receives FDA Clearance for Irrisept

"This new clearance from the FDA further solidifies Irrisept as the market leader in wound irrigation," said Mark Alvarez, CEO of Irrimax.

INTERCEPT Blood System Kit: William ‘Obi’ Greenman, Cerus’ president and chief executive officer explains, “This is a significant milestone for Cerus and highlights the scope our technology has had within the transfusion industry and on the millions of patients worldwide transfused with INTERCEPT treated platelet and plasma components. “We have a solid track record with the safety and efficacy of our INTERCEPT products, which now surpasses more than 7.5 million treatable doses.”

INTERCEPT Blood System Kit for platelets and plasma provides a proactive approach to reduce the risk of transfusion-transmitted infectious disease (TTID). Cerus’ proprietary pathogen-reduction technology provides a foundational strategy for safeguarding the blood supply against a broad spectrum of known and emerging pathogens. Annually, over 115 million units of blood are donated worldwide and there is no therapeutic alternative for patients who need blood1.

About the Cerus INTERCEPT Blood System:

  • Provides robust, broad-spectrum reduction of the risks of TTID, including sepsis, and can be used to replace bacterial detection, cytomegalovirus (CMV) and Babesia testing and gamma irradiation for prevention of transfusion-associated graft-versus-host disease (TA-GVHD).
  • INTERCEPT Blood System for platelets and plasma utilizes amotosalen, a photoactive compound activated with ultra-violet light that specifically targets DNA and RNA, irreversibly cross-linking nucleic acids, which blocks the replication of viruses, bacteria, and parasites.
  • Over a decade of national hemovigilance data on INTERCEPT treated platelets establishing a proven track record of safety and clinical utility . The INTERCEPT Blood System for platelets is now the standard of care in nine countries including France, Switzerland, Belgium, and Austria.
  • INTERCEPT complies with the FDA guidance on bacterial safety in platelets and also provides a proactive solution to address pandemic preparedness.
  • A recent study conducted at the King Abdulaziz University in Jeddah Saudi Arabia demonstrated that INTERCEPT Blood System inactivates SARS-CoV-2, the causative agent for COVID-19, in plasma components.
  • The use of INTERCEPT provides an alternative to the three-month donor deferral period for residents of non-malaria endemic countries after traveling to malaria-endemic regions, thereby potentially improving blood component availability for hospitals, blood banks, and ultimately, patients in need.


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Hyperfine Adds Medtech Leader and Visionary Scott Huennekens as Executive Chairman

Mr. Huennekens’ public boards include Chairman of Acutus Medical (IPO August 2020); Chairman of Envista (IPO September 2019); and board member of Nuvasive. He also serves as a board member and past Chairman of the Medical Device Manufacturer’s Association (MDMA).

One Drop Reports Carrie Siragusa, CPA Appointed VP of Commercial Strategy, Biosensor

Formerly Head of Innovation and Diabetes Portfolio at Sanofi, Siragusa will be part of a team bringing a multi-analyte dermal sensor (biosensor) with continuous health sensing capabilities to market with a mission to provide broader access to continuous glucose monitoring.

Barbara Moorhouse Appointed as Medica Non-Executive Director

Barbara has extensive business and management experience in the private, public, and regulated sectors.

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