Key Terms
class ii medical devices
regulatory
A regulatory category for medical devices that pose moderate risk to patients and therefore require more than basic controls but less than the strictest oversight. Class II devices are subject to special controls such as performance standards, specific labeling, testing requirements, and commonly a premarket notification process; thinking of it like a mid-level safety tier helps—more checks than a simple device but fewer than the highest-risk devices. This classification matters to investors because it shapes development time, regulatory costs, market entry speed, and ongoing compliance obligations.
class iii medical devices
regulatory
High-risk medical devices that support or sustain human life, prevent impairment, or present potential unreasonable risk (for example, implantable pacemakers or heart valves). They undergo the strictest regulatory review (typically a premarket approval process) because failures can cause serious harm; this means longer development timelines, higher testing and approval costs, and greater regulatory uncertainty, factors that can significantly affect a company’s time to market and financial outlook.
national medical products administration
regulatory
The National Medical Products Administration is the government agency responsible for reviewing, approving and supervising drugs, vaccines, medical devices and related products. Think of it as the country’s gatekeeper for medical products: its decisions determine whether a product can be sold, how quickly it reaches patients and what safety or labeling requirements apply, so its rulings directly affect a company’s sales prospects, regulatory risk and investor valuation.
PEACHTREE CORNERS, Ga.–(BUSINESS WIRE)–
Guided Therapeutics, Inc. (OTC:QB GTHP), the maker of the LuViva Advanced Cervical Scan, announced it had reached a new agreement with Yuanshuo Medical Instruments Corporation (YMIC) to supply them with LuViva instruments, single-use components and support services.
YMIC is headquartered in
The new agreement with YMIC is complementary to the current agreement GTHP has with Hangzhou Dongye Medical Technology Company, Ltd. (HDMT) to provide them with 35 devices, seven of which have been delivered with nine more scheduled for later in 2026. HDMT is in
About Guided Therapeutics
Guided Therapeutics, Inc. (OTCQB: GTHP) is the maker of a rapid and painless testing platform based on its patented biophotonic technology that utilizes light for the early detection of disease at the cellular level. The Company’s first product is the LuViva® Advanced Cervical Scan, a non-invasive device used to detect cervical disease instantly and at the point of care. In a multi-center clinical trial with women at risk for cervical disease, the technology was able to detect cervical cancer up to two years earlier than conventional modalities, according to published reports. For more information, visit: www.guidedinc.com.
The Guided Therapeutics LuViva® Advanced Cervical Scan is an investigational device and is limited by federal law to investigational use in the U.S. LuViva, the wave logo and “Early detection, better outcomes” are registered trademarks owned by Guided Therapeutics, Inc.
Forward-Looking Statements Disclaimer: A number of the matters and subject areas discussed in this news release that are not historical or current facts deal with potential future circumstances and developments. The discussion of such matters and subject areas is qualified by the inherent risks and uncertainties surrounding future expectations generally and also may materially differ from Guided Therapeutics’ actual future experience involving any of or more of such matters and subject areas. Such risks and uncertainties include those related to the early stage of commercialization of products, the uncertainty of market acceptance of products, the uncertainty of development or effectiveness of distribution channels, the intense competition in the medical device industry, the sufficiency of capital raised in prior financings and the ability to realize their expected benefits, the uncertainty of future capital to develop products or continue as a going concern, the uncertainty of regulatory approval of products, and the dependence on licensed intellectual property, as well as those that are more fully described from time to time under the heading “Risk Factors” in Guided Therapeutics’ reports filed with the SEC, including Guided Therapeutics’ Annual Report on Form 10-K for the fiscal year ended December 31, 2025 and subsequent filings.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260714809091/en/
Mark Faupel
Guided Therapeutics
770-242-8723
Source: Guided Therapeutics, Inc.
