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INSPIRA™ ART100 Receives FDA 510(k) Clearance

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RA’ANANA, Israel, May 28, 2024 /PRNewswire/ — Inspira™ Technologies OXY B.H.N. Ltd. (Nasdaq: IINN) (Nasdaq: IINNW) (the “Company”, “Inspira”, or “Inspira Technologies”), a breakthrough medical technology company, today announced that it has received notification of 510(k) class II clearance from the U.S. Food and Drug Administration (FDA) for its INSPIRA™ ART100, a Cardiopulmonary Bypass System.

Dagi Ben Noon, CEO of Inspira, said “This is a proud moment for all of us at Inspira Technologies. We would like to thank all our investors and partners who have been with us on this journey to get here.”

Professor Benad Goldwasser, the Chairman of the Board of Inspira, stated: “We believe that the FDA clearance marks a clear example of the Company’s technological and innovative advancements.”

About Inspira Technologies OXY B.H.N. Ltd.

Inspira™ Technologies is an innovative medical technology company in the life support arena. The INSPIRA™ ART (Gen 2), also known as the INSPIRA™ ART500, includes the Company’s Adaptive Blood Oxygenation technology and is being designed to continuously measure the patient’s blood parameters in real-time, delivering needed oxygen volume straight into the blood. By elevating patient oxygen saturation levels in minutes, this technology potentially allows patients to remain awake during treatment and therefore may enable patients to be treated in and beyond intensive care units, reducing the need for mechanical ventilation systems that requires intubation and medically induced coma.

The Company received FDA 510(k) clearance for its INSPIRA ART100, a Cardiopulmonary Bypass System.

The Company’s other products, including the INSPIRA ART (Gen 2) and HYLA™ blood sensor, have not yet been tested or used in humans and have not been approved by any regulatory entity.

For more information, please visit our corporate website: https://inspira-technologies.com

Forward-Looking Statement Disclaimer

This press release contains express or implied forward-looking statements pursuant to U.S. Federal securities laws. These forward-looking statements and their implications are based on the current expectations of the management of the Company only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. For example, the Company is using forward-looking statements when it discusses that the Company believes the FDA clearance is an example of its technological and innovative advancements and the potential benefits of its products and technologies. These forward-looking statements and their implications are based solely on the current expectations of the Company’s management and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as otherwise required by law, the Company undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. More detailed information about the risks and uncertainties affecting the Company is contained under the heading “Risk Factors” in the Company’s annual report on Form 20-F for the fiscal year ended December 31, 2023 filed with the U.S. Securities and Exchange Commission (the “SEC”), which is available on the SEC’s website, http://www.sec.gov

For more details:
Public Relations Manager
Adi Shmueli
Inspira Technologies
info@inspirao2.com
+972-9-9664485

Copyright © 2018-2024 Inspira Technologies OXY B.H.N. LTD., All rights reserved.

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3Shape Receives FDA 510(k) Clearance for 3Shape Dx Software

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COPENHAGEN, Denmark, April 28, 2026 /PRNewswire/ — 3Shape today announced that the U.S. Food and Drug Administration (FDA) has granted FDA clearance for its Dx Software following a review completed on April 10. 2026.

The 510(k) Premarket Notification allows Dx (R1) software to be commercially available in the United States for use by qualified dental professionals in dental clinics to aid in the diagnosis of key oral health conditions and the assessment of changes in teeth and gingiva in adult patients.

“I’m excited that we can now bring this transformative dental solution to doctors and patients across the United States,” says 3Shape CEO Jacob Paulsen. “Receiving FDA 510(k) clearance for Dx underscores our commitment to responsible innovation and to delivering digital solutions that meet the highest clinical and regulatory standards. With Dx software, dental professionals gain a powerful new way to communicate more clearly with patients about their oral health and treatment needs.”

The FDA clearance applies to both versions of 3Shape’s Dx software: Dx Plus and Dx Standard. Exclusively compatible with 3Shape TRIOS 6 scans, Dx Plus is an AI-assistive software that aids in the detection of key oral health conditions, including surface and proximal caries, plaque, tooth wear, and gingival recession. The Dx Standard software can help dentists engage patients by manually tracking and quantifying changes to their dentition. It is compatible with all 3Shape TRIOS models except TRIOS Core.

Dx supports routine checkups and can save time when preparing for a patient’s visit. Using Dx, dentists can visualize key oral health conditions with their patients onscreen and monitor them over time. Dx Plus visualizations turn clinical findings into clear, intuitive visuals that help patients better understand their diagnosis, build trust with their clinician, and feel more confident in recommended treatment plans.

The FDA clearance means that Dx software can now be marketed and sold to dental professionals in the U.S. Since 2025, the Dx software has been sold and used by clinicians across multiple international markets, including Europe, the Middle East, Africa, South America, and Canada.

3Shape’s Dx software is available in the U.S. starting today. Please contact your reseller or 3Shape representative for purchase information. Eligible customers can go to webshop.3shape.com to start a trial.

Press Contact:
Lina Danstrup
Director and Head of Corporate Communications
lina.danstrup@3shape.com

This information was brought to you by Cision http://news.cision.com

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View original content:https://www.prnewswire.com/news-releases/3shape-receives-fda-510k-clearance-for-3shape-dx-software-302755373.html

SOURCE 3Shape

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Beyond Simulation: Sungrow Completes World’s First Large-Scale Full-Condition Grid-Forming Extreme Test

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HEFEI, China, April 28, 2026  /PRNewswire/ — Sungrow, the globally leading PV inverter and energy storage system provider, successfully completed the world’s first large-scale grid-forming full-scenario validation.  The program covered 14 scenarios over 138 hours and was independently witnessed and verified by TÜV Rheinland. All results met multiple international standards, confirming reliable operation under complex grid conditions.

As global power systems rapidly transition toward high shares of renewable energy, grid stability is becoming a critical challenge. The test base features a world-leading 30MW grid simulation platform, along with the real short-circuit capacity regulation equipment and advanced arc-fault testing devices, enabling the replication of complex and extreme grid conditions at full scale. These tests align with grid codes and requirements across major global markets, including Europe, Australia, and China, addressing growing challenges related to grid stability and high renewable penetration worldwide.

Validated Performance Across Main Critical Grid Scenarios

Short-Circuit Performance: Reliable Fault Support

A short-circuit test was conducted using real arc-fault equipment to simulate the most severe fault conditions. Under identical fault scenarios, the grid-forming system remained connected and continuously supplied fault current, while conventional systems are more likely to disconnect.

Key advantages:

Response time as fast as 10 ms

Stable and continuous fault current contribution

Strong fault ride-through capability

Inertial Response: Stronger Frequency Stability

Compared with conventional grid-following systems, which may lose stability under the same disturbance, Sungrow’s solution maintained continuous operation and restored frequency stability within milliseconds.

Key advantages:

Millisecond-level response to frequency deviations

Stable operation under sudden disturbances

Improved system resilience in weak grids

Black Start: Rapid System Recovery

In a full blackout test, all external power was disconnected from the site. During this test, Sungrow’s grid-forming PCS (Power Conversion System) established system voltage within 19 seconds, then successfully restarted the entire facility, restoring loads and infrastructure without external support. This capability enables industry-leading GW-scale black start and significantly enhances system restoration speed.

Key advantages:

Faster restoration

GW-scale black-start capability

virtually no circulation current

In addition to the three tests mentioned above, another eleven tests including on/off-grid switching, load switching, and oscillation damping were also successfully completed.

As demand for grid-forming technologies continues to grow, validating their real-world performance is becoming increasingly important. Reliance solely on digital power system simulations is not sufficient, while live testing provides more reliable and real validation. “Based on two decades of experience on grid-forming technology and in-depth understanding of power system stability requirements, Sungrow has built a 30 MW large-scale simulation platform and conducted 14 comprehensive real-world extreme test scenarios,” said Henry Liu, General Manager of the Microgrid and Grid Solutions Center at Sungrow. “These results demonstrate grid-forming capabilities and mark a critical step toward the large-scale deployment of grid-forming technologies.”

Sungrow will continue to advance the development of evaluation frameworks and industry standards, supporting broader adoption and enabling more stable, resilient power systems worldwide.

About Sungrow
Sungrow, a global leader in renewable energy technology, has pioneered sustainable power solutions for over 29 years. As of Dec 2025, Sungrow has installed over 1000 GW of power electronic converters worldwide. The company is recognized as the world’s most bankable PV inverter and energy storage company (BloombergNEF). Its innovations power clean energy projects across the globe, supported by a network of 520 service outlets guaranteeing excellent customer experiences. At Sungrow, we’re committed to bridging to a sustainable future through cutting-edge technology and unparalleled service. For more information, please visit: www.sungrowpower.com/en

Contact:
luly.wang@sungrow-hq.com 

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Noah Holdings Opens Thangka Intangible Cultural Heritage Exhibition in Shanghai, Celebrating a New Generation of Inheritors

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“The Call of the Third Pole — Visage of the Future” Runs April 26 Through July 31 at the Noah N+ Art Center

SHANGHAI, April 28, 2026 /PRNewswire/ — Noah Holdings Limited (“Noah” or the “Company”) (NYSE: NOAH and HKEX: 6686), an AI-native wealth management firm headquartered in Singapore and serving global Chinese families, recently opened a themed exhibition of Thangka intangible cultural heritage at the Noah N+ Art Center in Shanghai.

As global wealth becomes increasingly cross-border and multi-generational, families are finding that cultural continuity matters just as much as financial allocation.

The exhibition, titled “The Call of the Third Pole — Visage of the Future,” presents works by new-generation inheritors of Regong arts and Thangka tradition. Their artistry bridges centuries of tradition with contemporary expression, offering a glimpse into the future of this ancient craft.

The opening coincides with the Symposium on the High-Quality Inheritance and Innovative Creation of Intangible Buddhist Civilizational Art, reinforcing the Noah N+ Art Center’s role as a space where cultural preservation and wealth management intersect to serve the needs of global Chinese families.

A Six-Century Tradition, Seen Through the Eyes of Its Next Generation

Thangka is a form of Tibetan Buddhist scroll painting with more than six centuries of documented lineage, originating on the Tibetan Plateau and often described as “the language of the Third Pole.”

The exhibition presents works by a selected cohort of next-generation inheritors of the Regong and Menthang schools, the two most influential lineages in Thangka painting. Hailing from Lhasa and Shigatse in Tibet, as well as from Regong, the renowned hometown of intangible cultural heritage Thangka art, the artists have an average age of under 40, and most began formal apprenticeships between the ages of 8 and 10.

A single Thangka can take anywhere from six months to several years to complete, using mineral pigments such as malachite, cinnabar, and pure gold. Each piece adheres to the precise iconometric canons of the Sutra of Iconometric Measurements. Recognized for its cultural significance, Thangka was inscribed on China’s first National List of Intangible Cultural Heritage in 2006, and Regong Arts was inscribed on UNESCO’s Representative List of the Intangible Cultural Heritage of Humanity in 2009.

For many high-net-worth families, preserving such traditions is no longer separate from wealth planning. It is part of how they define and transfer value across generations.

Where Cultural Heritage Meets Wealth Stewardship

The exhibition is the second major curatorial project of the Noah N+ Art Center, following its inaugural exhibition, “Hub: The Endless Exploration of Art”. Guided by the philosophy of “art as life,” it reflects Noah Holdings’ broader commitment to fostering cultural preservation as an extension of its mission to serve global Chinese families, whose needs increasingly span asset allocation, wealth inheritance, and longer-horizon questions of cultural continuity.

“Long-lasting value, whether financial or cultural, is not measured in cycles. It is nurtured across generations. We are seeing a growing number of global Chinese families realize this and integrate both financial and cultural heritage into their longer-term vision of wealth.” Zander Yin, Co-Founder and Chief Executive Officer of Noah Holdings, said, “Asset allocation is our profession, and cultural grounding supports how we create value. By presenting the work of a new generation of Thangka painters before their work has gained wider recognition, we provide clients with early and exclusive access to cultural value. We see this as consistent with how we approach allocation itself: identifying value before it is fully priced.”

For global Chinese families whose inheritance questions now span jurisdictions and generations, cultural continuity has become part of the conversation about wealth itself. The Noah N+ Art Center is built around that longer horizon: it is a place to connect with a living tradition, and more importantly, engage with the artists shaping its future before everybody else does.

Exhibition Information & Reservations
Dates: April 26–July 31, 2026
Venue: Noah N+ Art Center, Hongqiao International Business District, Shanghai
Hours: Tuesday to Sunday, 10:00 – 18:00 (closed Mondays)

Special Programs (running throughout the exhibition period):

Weekend curator-led guided toursOn-site dialogues with participating Thangka painters (limited seating; by reservation only)Third Pole Tea Gatherings, themed afternoon sessions

Reservations: https://promotion.noahgroup.com/activity/prod/jNkpMZbPn1

About Noah Holdings

Noah Holdings Limited (NYSE: NOAH | HKEX: 6686) is an AI-Native wealth management firm headquartered in Singapore, dedicated to being where global Chinese wealth connects. The firm serves high-net-worth families and distinguished institutions worldwide.

Founded in 2005 and dual-listed on the New York Stock Exchange (2010) and the Hong Kong Stock Exchange (2022), Noah brings over 23 years of disciplined wealth stewardship. With four global booking and trading centers across Singapore, Hong Kong SAR, Shanghai, and the United States, Noah has allocated over US$153 billion in cumulative assets for clients spanning nine countries and more than 30 jurisdictions.

Noah serves clients through three flagship brands — ARK Wealth Management (Human + AI Integrated Global Wealth Management Platform), Olive Asset Management (Global Asset Allocation Platform), and Glory Family Heritage (Global Family Legacy & Lifestyle Platform). Together, they form an integrated global wealth management system under a unified governance framework, guided by wealth expertise with deeper global Chinese insight.

Beyond financial services, Noah’s Global N+ Ecosystem unites global Chinese families across generations through curated experiences in art, music, and culture. The inheritance of wealth ultimately returns to the inheritance of culture and spirit, and it is this that defines Noah’s philosophy: Wisdom Beyond Wealth.

For more information, please visit: https://www.noahgroup.com/.

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SOURCE Noah Holdings Limited

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