Business Wire

OLEA-MEDICAL

21.3.2016 13:01:50 CET | Business Wire | Press release

Share
Olea Medical Receives FDA Clearance for Olea Sphere 3.0

March 21, 2016: Olea Medical, a provider of advanced MR and CT perfusion imaging post-processing announces FDA clearance of Olea Sphere® 3.0 medical imaging enterprise software package in the US.

Olea Sphere® is an image processing software package intended for picture archive, post-processing and communication. It helps standardize both viewing and analysis capabilities of functional and dynamic imaging datasets acquired with MRI and CT across vendors. It features innovative image viewing, analysis and processing of most complex MR sequences as well as longitudinal analysis of multiple time points. Olea Sphere® is compliant with the DICOM standard and Windows® or Linux® operating systems. Olea Sphere® runs on any standard off-the-shelf workstation or it can be used through thin deployment. It maintains the traceability of patient data, through an automatic logout mode, a total connectivity and compatibility with LDAP and Microsoft Active Directory.

New advanced post-processing modules to be introduced on the US market following the FDA clearance are IVIM (Intravoxel Incoherent Motion), Metabolic and Relaxometry. With this clearance, Olea Medical becomes the first manufacturer to provide advanced post-processing for IVIM imaging, integrating their proprietary Bayesian method. IVIM MRI is a powerful feature of diffusion MRI allowing the non-invasive of evaluation blood micro-circulation in tissues without the use of contrast agents.

"The FDA clearance of this new version of Olea Sphere® , including new advanced post-processing modules, is a confirmation of our capacity of innovation. It is with great pride that we introduce these new developments on a highly demanding market. We believe such new options will add significant value in the day-to-day clinical practice for the highest benefit to patients worldwide." says Fayçal Djeridane, president and CEO of Olea Medical.

Professor Denis Le Bihan, Kyoto University: "I am thrilled to see that IVIM MRI, 30 years after its invention, is now available for clinical use. This is another major milestone for Diffusion MRI which will extend further its benefits to many patients. I am especially grateful to Olea to have made it possible and proud to collaborate with Olea’s staff on this topic."

About Olea Medical: Olea Medical® , a Toshiba Medical Systems Group Company, is a provider of advanced MR and CT perfusion imaging post-processing, designs and markets a suite of innovative medical imaging applications, Olea Sphere® , significantly improving diagnostic process and follow-up assessment. The company has established a strong credibility through the domestication of cutting-edge technology and partnerships with leading institutions worldwide. With proprietary Bayesian algorithms and optimization methods applied to medical imaging, today Olea Medical® is the recognized leader in standardized, vendor-neutral, advanced MR quantitative and qualitative image post-processing. Covering both morphologic and functional imaging, Olea Medical® post-processing solutions bring complex Mathematics into clinical practice for easy access to accurate and robust biomarkers for enhanced diagnostic confidence and response-to-treatment assessment.

More information at www.olea-medical.com

About Toshiba Medical Systems Corporation
Toshiba Medical Systems Corporation is a leading worldwide provider of medical diagnostic imaging systems and comprehensive medical solutions, such as CT, X-ray and vascular, ultrasound, nuclear medicine and MRI systems, as well as information systems for medical institutions. Toshiba Medical Systems Corporation has been providing medical products for over 80 years. Visit Toshiba Medical Systems Corporation's website at www.toshibamedicalsystems.com .

Olea Medical and Olea Sphere are trademarks of Olea Medical SA.
Windows is a registered trademark of Microsoft Corporation in the United States and other countries.
Linux is a registered trademark of Linus Torvalds in the United States and other countries.

Contact:

Press Contact:
Anca Mitulescu: +33 (0) 4 42 71 24 20
VP Clinical Affairs & Marketing
Olea Medical
anca.mitulescu@olea-medical.com

Link:

ClickThru

About Business Wire

Business Wire
Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco

http://businesswire.com

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Curatis: Double-Digit Revenue Growth in 2025 and Major Milestones for Corticorelin Achieved24.3.2026 07:00:00 CET | Press release

Curatis Holding AG (SIX:CURN, “Curatis”) reports business revenues of CHF 10.8m (+57%) for 2025. Curatis AG increased sales in its distribution business organically by 13%, from CHF 9.5m to CHF 10.8m. The net result improved from a loss of CHF 4.3m in 2024 to a loss of CHF 1.4m in 2025. Further key statements In September 2025, our development plan for corticorelin was validated at a meeting with the FDA, enabling Curatis to proceed toward a regulatory submission supporting a pivotal study in patients suffering from peritumoral brain edema (PTBE). In November 2025, Curatis raised CHF 1.2m to progress corticorelin. The cash position as of year end 2025 was comfortable, standing at CHF 1.9m. Recently, Curatis announced a license agreement for corticorelin for Japan with significant milestone payments. Business development and finances In 2025, product sales amounted to CHF 10.3m, while service revenue amounted to CHF 0.5m. On a full year basis, Curatis AG increased revenues in its distri

AAD 2026: Galderma Showcases Latest Evidence Supporting Its Full-Spectrum, Science-Driven Solutions for Diverse Skin Needs24.3.2026 07:00:00 CET | Press release

From its Therapeutic Dermatology portfolio, Galderma will present data on the efficacy and safety of Nemluvio® (nemolizumab) in different patient populations with moderate-to-severe atopic dermatitis, including late-breaking data in pediatric patients, and share four posters on AKLIEF® (trifarotene)1-8 Additional presentations related to Dermatological Skincare will explore how artificial intelligence can identify high-risk factors for sensitive skin and Cetaphil® in different skin types9 Data from Galderma’s Injectable Aesthetics portfolio will also show how its hyaluronic acid injectables, Restylane®, and neuromodulator, RelabotulinumtoxinA*, may address aesthetic needs across the face and décolletage10-14 A total of 22 presentations will reinforce the value of Galderma’s broad and comprehensive portfolio in meeting varied patient needs across Therapeutic Dermatology, Injectable Aesthetics and Dermatological Skincare Galderma (SIX: GALD), the pure-play dermatology category leader, wi

Avanzanite Expands French Operations and Appoints Constance Sabbagh as General Manager24.3.2026 07:00:00 CET | Press release

Avanzanite Bioscience B.V., a rapidly growing commercial-stage European specialty pharmaceutical company focused on rare diseases, today announced its expansion into France, Europe’s second largest economy, and the appointment of Constance Sabbagh as General Manager, France. Following a €32 million Series A investment by MVM Partners announced in November 2025, Avanzanite is scaling its European infrastructure into a single, integrated platform across 32 countries – designed to bring rare disease medicines to patients in every European market. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260323639110/en/ Constance Sabbagh, General Manager, France “France is essential to Avanzanite’s European vision,” said Adam Plich, Co-founder and CEO of Avanzanite. “With its leadership in rare disease policy through its National Rare Disease Plans, care networks and scientific innovation, France is one of the most significant healthcare

HJS Foundation Releases JEP Protocol & HJS Framework: The "Black Box" for AI, Enabling Verifiable Human Oversight24.3.2026 04:36:00 CET | Press release

HJS Foundation (Human Judgment Systems Foundation) today released two complementary solutions: the Judgment Event Protocol (JEP) and the Human Judgment Structure (HJS) framework. As a minimalist open standard, JEP generates tamper-proof records of AI decision accountability, just like an aircraft black box; HJS embeds human judgment logic into AI operation processes — together, they transform "human oversight" from a regulatory requirement into a verifiable technical fact, providing an optional technical solution for AI accountability. How to prove that AI decisions (such as loan approvals, medical diagnoses, border screenings, etc.) have undergone human review? JEP generates immutable audit trails of human intervention through four cryptographic primitives — Judge, Verify, Delegate, Terminate; HJS builds a controllable and accountable system to prevent risks such as AI drift and ensure that human judgment guides AI operations. Current systems rely on alterable post-hoc documentation,

Power Integrations Extends Flyback Topology to Enable 440 W, Offering Simpler Alternatives to Resonant Power Designs23.3.2026 22:45:00 CET | Press release

New TOPSwitchGaN ICs more than double power output, reducing system cost, complexity, and design time APEC 2026 – Power Integrations (NASDAQ: POWI), the leader in high-voltage integrated circuits for energy-efficient power conversion, today introduced a breakthrough in flyback topology extending the power range of flyback converters to 440 W—well beyond the limits that traditionally required more complex resonant and LLC topologies. The new TOPSwitchGaN™ flyback IC family unites the company’s groundbreaking PowiGaN™ technology with its iconic TOPSwitch™ IC architecture, reducing complexity, eliminating heat sinks in many cases, shortening design time, improving manufacturability, and lowering total system cost. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260323686299/en/ The new TOPSwitchGaN™ flyback IC family extends the power range of flyback converters to 440 W—well beyond the limits that traditionally required more co

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye