Emerging Medical Technologies

This website provides licensing guidance for emerging medical technologies. The licensing guidance consists of general licensing considerations, specific radiation safety aspects of the emerging medical technology, and training and experience expectations for those authorized to use the emerging medical technology. This website may also help stakeholders who are developing new methods and technologies that may one day be used to treat medical patients. It also contains a record of the emerging medical technologies whose use has been evaluated for licensing by the NRC. Contact Us to submit medical-related inquiries.

On this page:

• NRC Regulation of Emerging Medical Technologies
• Status of NRC Review of Emerging Technologies

NRC Regulation of Emerging Medical Technologies

Title 10 of the Code of Federal Regulations Part 35, Subpart K – Other Medical Uses of Byproduct Material or Radiation From Byproduct Material (10 CFR 35.1000) describes the process to obtain a license, or an amendment to a license, for a new medical use of byproduct material or radiation from byproduct material, which is not addressed in other parts of 10 CFR Part 35 (i.e., an emerging medical technology). Additional requirements are included in 10 CFR 35.12(d), "Application for license, amendment, or renewal."

 

Status of NRC Review of Emerging Technologies

Below is an Emerging Technologies Table: a current list of emerging technologies, status, and links to corresponding documents.

 

Note: New entries will be added as additional emerging technologies are identified. Licensing guidance will be updated when necessary to address comments from stakeholders. To submit comments on or inquire about a specific licensing guidance document, contact the individual listed in that document or contact us using our electronic form. If applicable, you can also contact the appropriate NRC Regional Office or Agreement State for assistance.

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Emerging Technologies
Technology Name	Status	Document Date	Document(s)
Best Vascular, Inc. Beta-Cath Intravascular Brachytherapy (IVB) System	Licensed under 35.1000	August 2006	Licensing Guidance
Germanium-68/Gallium-68 Pharmaceutical Grade Generators Licensing Guidance	Licensed under 35.1000	July 2019	Licensing Guidance
GT Medical Technologies Gammatile	Licensed under 10 CFR 35.400	August 2019	MEMO: Licensing for Medical Technologies Gammatile
I-125 Iotrex Liquid Brachytherapy Source in Cytyc GliaSite Radiation Therapy Systemm	Licensed under 35.1000	August 2006	Licensing Guidance
Low Activity Radioactive Seeds Used for Localization of Non-Palpable Lesions and Lymph Nodes Licensing Guidance	Licensed under 35.1000	October 2016	Licensing Guidance Supersedes: Sept 2006
Leksell Gamma Knife® Perfexion™ and Leksell Gamma Knife® Icon™	Licensed under 35.1000	January 2019	Licensing Guidance Supersedes: May 2016 July 2007 (Perfexion only)
Lutetium-177 Radiopharmaceuticals	Licensed under 35.300	June 2018	Licensing of Lutetium-177
NeoVista, Inc's Epi-Rad90 (Sr-90) Ophthalmic System	Licensed under 35.1000	April 2009	Licensing Guidance
NorthStar Medical Radioisotopes, LLC RadioGenix™ Molybdenum-99/Technetium-99m Generator System Licensing Guidance for Medical Use Licensees, Medical Use Permittees, and Commercial Nuclear Pharmacies	Licensed under 35.1000 and 10 CFR 30.33	January 2020	Licensing Guidance (Revision 1) Supersedes: Feb 2018
Nucletron seedSelectron® System, Isotron Brachytherapy Sources and Nucletron FIRST™ System	Retracted	N/A	N/A
Radium-223 Dichloride	Licensed under 35.300	January 2013	MEMO: Licensing for Ra-223 Dichloride
TheraSphere and SIRSpheres Yttrium-90 Microspheres	Licensed under 35.1000	November 2019	Licensing Guidance;To become effective on May 6, 2020 Licensing Guidance (Revision 9) Supersedes: June 2012 Oct 2011 Jan 2011 Sept 2008 Aug 2008 Dec 2007 Sept 2007 Jan 2004 Oct 2002
ViewRay System for Radiation Therapy	Licensed under 35.1000	July 2013	Licensing Guidance
Xcision® GammaPod™ Licensing Guidance	Licensed under 35.1000	January 2020	Licensing Guidance