Clinical and Regulatory Research — Aires Medical Device Certification – airestech

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Clinical and Regulatory Research — Aires Medical Device Certification

Research Cluster

Clinical and Regulatory Research

Three phases of human clinical research and the regulatory pathway that resulted in Russian Federation medical device certification for Aires technology.

Overview

The Aires research program included three sequential phases of human clinical research conducted as part of the formal submission process for medical device certification by the Russian Federation. The certification was ultimately granted by the Federal Supervisory Agency for Health Care and Social Development of the Russian Federation (Roszdravnadzor) — the Russian regulatory equivalent of the US FDA for medical devices.

Clinical research in this context served a specific regulatory purpose: providing human physiological data to supplement the physical and animal model findings from other phases of the research program. The three phases followed a structured escalation of scope and endpoint complexity.

Regulatory outcomeThe clinical research program contributed to the basis for medical device certification by the Federal Supervisory Agency for Health Care and Social Development of the Russian Federation. This certification is a government regulatory determination — not a manufacturer claim.

The Three Clinical Phases

Phase I

Initial Clinical Assessment

The Phase I clinical report established baseline safety and initial efficacy parameters for the Aires resonator in human subjects. Phase I research in the regulatory context focuses on safety profiling and initial characterization of physiological effects — providing the evidentiary foundation for subsequent phases with expanded subject populations and endpoint complexity.

Phase I findings informed the protocol design for Phase II and provided the first human physiological data in the Aires research program.

Phase II

Expanded Clinical Study

Phase II expanded the subject population and measurement endpoints established in Phase I. This phase included more detailed physiological monitoring and a broader range of outcome measures, examining the consistency of effects observed in Phase I across a larger and more diverse subject group.

The Phase II findings, together with the animal model data from the IFRAN program, formed the primary evidentiary basis for the initial regulatory submission.

Phase III

Confirmatory Clinical Research

The Phase III clinical report represents the most comprehensive human research in the program. This phase used confirmatory protocols — pre-specified endpoints and analysis plans — to provide the highest-quality clinical evidence for the regulatory dossier.

Phase III findings, combined with Phase I and II data, contributed directly to the successful certification of the Aires device as a medical device by the Russian Federal Supervisory Agency for Health Care and Social Development.

Additional Regulatory Documentation

In addition to the three clinical phase reports, the regulatory dossier included the 140_PC technical report — a comprehensive technical document covering device specifications, manufacturing standards, and quality control parameters relevant to the medical device certification process.

Context: Russian Federation medical device regulationRoszdravnadzor (the Federal Service for Surveillance in Health Care) is the Russian government agency responsible for medical device oversight. It reviews clinical evidence, manufacturing standards, and safety data before granting medical device status — a process comparable in structure (though not identical) to 510(k) clearance or PMA review by the US FDA. Devices certified by Roszdravnadzor are legally classified medical devices in the Russian Federation.

Peer Review: PACE Expert Assessments

The Planetary Association for Clean Energy (PACE) — an international scientific organization with consultative status at the United Nations Economic and Social Council (ECOSOC) — conducted seven independent expert peer review assessments of studies in the Aires research corpus. These reviews provide external scientific evaluation by a body with established UN consultative standing, independent of both the Russian regulatory process and the Aires organization.

Read the PACE peer review documentation

Independent Human Subject Studies

Outside the formal clinical phase program, several independent research groups conducted human subject studies with Aires devices:

Trent University (Dr. Magda Havas, 2015) — Two double-blind, placebo-controlled case studies examining cardiovascular effects of Wi-Fi EMF exposure. Used an FDA Class II medical device (MaxPulse cardiac monitor) for heart rate variability measurement. Studies included an electromagnetically hypersensitive subject and a standard subject, both under controlled exposure conditions.

UFC Performance Institute (Dr. Duncan French) — Study measuring EEG brain wave parameters, visual and auditory reaction time, and heart rate variability in elite UFC athletes before and after Aires device use.

Multiple EEG studies — Independent EEG researchers including Rybina (2020), Sysoev, and the joint Sysoev-Rybina 2025 study examined electroencephalogram parameters in subjects under EMF exposure conditions with and without an Aires device.

Related Research Clusters

Explore the Full Research Archive

Every study in the Aires program has a dedicated page with author information, institution details, and plain-language summaries.

Browse All StudiesHow the Technology Works