ML23257A212
| ML23257A212 | |
| Person / Time | |
|---|---|
| Issue date: | 09/14/2023 |
| From: | Celimar Valentin-Rodriguez NRC/NMSS/DMSST/MSEB |
| To: | Christian Einberg Office of Nuclear Material Safety and Safeguards |
| References | |
| Download: ML23257A212 (3) | |
Text
UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 MEMORANDUM TO:
Christian Einberg, Chief Medical Safety and Events Assessment Branch Division of Materials Safety, Security, State, and Tribal Programs Office of Nuclear Material Safety and Safeguards FROM:
Celimar Valentin-Rodriguez, Team Leader Medical Safety and Events Assessment Branch Division of Materials Safety, Security, State, and Tribal Programs Office of Nuclear Material Safety and Safeguards
SUBJECT:
SUMMARY
OF AUGUST 31, 2023, CLOSED MEETING WITH TERUMO MEDICAL CORPORATION TO DISCUSS HOLMIUM PLATFORM AND QUIREMSPHERES MEDICAL DEVICE
Background
Terumo Medical Corporation (Terumo) is a medical device company that is developing a medical device platform with holmium (Ho)-166 microspheres, for the treatment of unresectable liver tumors. The platform consists of three products: QuiremScout', a diagnostic Ho-166 microsphere product to optimize patient selection and advance treatment planning; QuiremSpheres', a therapeutic microsphere device using the same microspheres as QuiremScout'; and Q-Suite', dedicated software for treatment planning and posttreatment dosimetry to verify administered doses.
Meeting Summary On August 31, 2023, NRC staff met with representatives from Terumo during a closed meeting to discuss their holmium platform. Terumo provided an overview of the device platform, including proprietary information and discussed their estimated timeline for commercialization in the United States. The NRC staff answered questions regarding the licensing process and emerging medical technologies regulatory process.
The enclosure lists the closed meeting attendees. No written materials were prepared or distributed by the NRC staff for this meeting.
ENCLOSURE:
As stated September 14, 2023 Signed by Valentin-Rodriguez, Celimar on 09/14/23
C. Einberg 2
ENCLOSURE CLOSED MEETING WITH TERUMO MEDICAL CORPORATION TO DISCUSS HOLMIUM PLATFORM AND QUIREMSPHERES MEDICAL DEVICE August 31, 2023 10:00 AM - 12:00 PM ET Meeting Attendees Name Affiliation Christian Einberg U.S. NRC, Office of Nuclear Material Safety and Safeguards, Division of Materials Safety, Security, State, and Tribal Programs, Medical Safety and Events Assessment Branch (NRC/NMSS/MSST/MSEB)
Celimar Valentin-Rodriguez NRC/NMSS/MSST/MSEB Maryann Ayoade NRC/NMSS/MSST/MSEB Ken Brenneman NRC/NMSS/MSST/MSEB Daniel DiMarco NRC/NMSS/MSST/MSEB Cindy Flannery NRC/NMSS/MSST/MSEB Daniel Shaw NRC/NMSS/MSST/MSEB Sarah Spence NRC/NMSS/MSST/MSEB Katherine Tapp NRC/NMSS/MSST/MSEB Shirley Xu NRC/NMSS/MSST/MSLB Joseph Rolland NRC/NMSS/MSST, Materials Safety and Licensing Branch (MSLB)
Brenda Sida NRC/NMSS/MSST/MSLB Alessandro Flores Saenz NRC/NMSS/MSST/MSLB James Hinderer Terumo Medical Corporation Laura Lantry Terumo Medical Corporation Nima Kokabi, MD UNC School of Medicine Nick Begin Terumo Medical Corporation Dina Justice Terumo Medical Corporation Ashley Cockerham Orchestra Life Sciences
Memo ML23257A212 OFFICE NMSS/MSST/MSEB NMSS/MSST NAME CEinberg CValentin-Rodriguez DATE Sep 14, 2023 Sep 14, 2023