Question 1

What types of medical devices does Olea Medical develop and for what purposes?

Accepted Answer

Olea Medical specializes in software-based medical imaging solutions focused on neurological and perfusion analysis. Their devices include NEUROSCAPE, designed for brain imaging and analysis, and PERFSCAPE (V1.0 and V2.0), which assesses cerebral perfusion—blood flow to the brain. Additionally, they offer MR Diffusion Perfusion Mismatch V1.0, a tool used to evaluate perfusion deficits in magnetic resonance imaging (MRI). These solutions are intended to assist clinicians in diagnosing and monitoring neurological conditions by providing detailed imaging insights.

Question 2

Where is Olea Medical based, and how does its location impact its regulatory approach?

Accepted Answer

Olea Medical is based in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations. The FDA classifies Olea Medical’s devices as Class II, which typically requires pre-market notification via the 510(k) pathway to demonstrate substantial equivalence to a legally marketed predicate device before commercial distribution. This pathway ensures that the devices meet safety and performance standards before entering the market.

Question 3

Which regulatory registries or databases list Olea Medical’s devices, and why is this important?

Accepted Answer

Olea Medical’s devices are listed under the FDA’s 510(k) pathway, meaning they are documented in the FDA’s 510(k) Premarket Notification Database. This registry is important because it provides transparency about the device’s regulatory history, including the basis for its classification as Class II and the evidence submitted to demonstrate compliance with FDA requirements. Healthcare providers and regulators can reference this database to verify the device’s authorised status and intended use.

Question 4

How are Olea Medical’s devices classified by regulatory authorities, and what does this classification mean?

Accepted Answer

Olea Medical’s devices are classified as FDA Class II by regulatory authorities. This classification indicates a moderate level of risk, requiring special controls beyond general controls to ensure safety and effectiveness. While Class II devices do not typically require clinical trials like Class III devices, they must still undergo a 510(k) premarket submission to prove they are substantially equivalent to an existing, legally marketed device. This classification helps balance regulatory oversight with innovation in medical imaging software.

Device	Model / Reference	Registries	Class	Status
Olea Sphere	3.0	FDA UDI	Class II	Active
MR DWI/FLAIR Measurement	V1.0	FDA UDI	Class II	Active
Olea Sphere	2.3	FDA UDI	Class II	Unknown
Automation Platform V1.5	1.5	FDA UDI	Class I	Active
Olea S.I.A. Neurovascular	V1.0	FDA UDI	Class II	Active
Breastscape	V1.0	FDA UDI	Class II	Active
CT Perfusion	V1.0	FDA UDI	Class II	Active
Olea S.I.A V1.0	1.0	FDA UDI	Class I	Active
Functional Mr	V1.0	FDA UDI	Class II	Active
MR Diffusion Perfusion Mismatch	V1.0	FDA UDI	Class II	Active
Automation Platform	1.0	FDA UDI	Class I	Unknown
Neuroscape	K083491	FDA 510(k)	Class II	Active
Perfscape V2.0	K111161	FDA 510(k)	Class II	Active
Perfscape	K091444	FDA 510(k)	Class II	Active
MR Diffusion Perfusion Mismatch V1.0	K223502	FDA 510(k)	Class II	Active

Olea Medical

What Olea Medical makes

Frequently asked questions

Information

Catalogue (15)

Related Companies

Authorised Representatives

Importers

Notified Bodies

Authorities

FDA Establishments (1)