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FDA Watch: The Quiet Gold Rush in AI-Powered Medical Devices

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Equity Insider News Commentary

Issued on behalf of Avant Technologies Inc.

VANCOUVER, BC, April 2, 2025 /PRNewswire/ — Equity Insider News Commentary – Artificial Intelligence (AI) is quickly becoming a major force in healthcare, as use of AI applications in medical fields is growing rapidly. Researchers at Dartmouth recently conducted the first clinical trial of a therapy chatbot powered by generative AI (genAI), and found that it resulted in significant improvements in participants’ symptoms. Cleveland Clinic and UAE-based G42 recently started collaborating on the advancement of even more AI in healthcare adoption, signalling an international push in this revolution. Because of this, the market is paying even more attention to developers in tech that are adding tools to the mix, with recent updates coming from Avant Technologies, Inc. (OTCQB: AVAI), Apple Inc. (NASDAQ: AAPL), Amazon.com, Inc. (NASDAQ: AMZN), Spectral AI, Inc. (NASDAQ: MDAI), and GE HealthCare Technologies Inc.  (NASDAQ: GEHC).

The article continued: Billionaire Bill Gates recently predicted that he thinks AI will make medical advice free and commonplace, changing healthcare at a rapid pace along the way. Private company Layer Health just raised a fresh $21 million to take on Healthcare AI’s scalability challenges, with investment from Define Ventures, Flare Capital Partners, GV and MultiCare Capital Partners.

Avant Technologies Partner, Ainnova, to Sponsor and Present at 2025 Healthcare Innovation Summit in Mexico City 

Avant Technologies, Inc. (OTCQB: AVAI), an emerging leader in AI-driven healthcare innovation, continues to build momentum in the AI-driven healthcare sector through its joint venture with Ainnova Tech, developers of the Vision AI platform. Today, the two companies announced that Ainnova will sponsor and present at the 2025 Mexico Healthcare Innovation Summit—an international event focused on digital transformation and diagnostics.

Ainnova’s CEO, Vinicio Vargas, will present on preventative healthcare powered by artificial intelligence, highlighting the practical impact of its Vision AI platform on early disease detection, which the company recently began designing the clinical trial protocols for ahead of a pre-submission meeting with the US Food and Drug Administration (FDA).

Vargas’s appearance at the event reinforces a consistent strategy for Avant and Ainnova: increasing visibility across key international markets ahead of major regulatory milestones to come.

It also follows Ainnova’s recent strategic alignment with Apollo Hospitals in Southeast Asia, where the Vision AI platform has been cleared for commercial deployment in Brazil, and clinical pilots are being prepared across the Americas.

As previously mentiond, Ainnova is being guided by global CRO Fortrea ahead of the important pre-submission meeting with the FDA. The goal is to seek 510(k) clearance for Vision AI in detecting diabetic retinopathy, a gateway to broader use across multiple chronic disease categories.

Avant and Ainnova jointly control Ai-nova Acquisition Corp. (AAC), which holds global licensing rights to the technology portfolio, including proprietary retinal cameras and algorithms validated on more than 2.3 million clinical data points.

Between FDA progress, high-profile alliances, and a growing international presence, Avant Technologies continues to carve out a niche in the convergence of AI, diagnostics, and preventative care. Investors looking for small-cap exposure to the healthcare AI revolution may want to keep AVAI on the radar as these developments unfold.

CONTINUED… Read this and more news for Avant Technologies at:

https://equity-insider.com/2025/03/21/unlocking-the-trillion-dollar-ai-market-what-investors- need-to-know/ 

Apple Inc. (NASDAQ: AAPL) is reportedly working on an AI-driven health coach, under the codename Project Mulberry, as a revamped version of its Health app. For a while now, CEO Tim Cook has been promising that Apple’s long-term plans include a big push into more health-related technologies.

According to Bloomberg’s Mark Gurman, Apple could launch this as early as next year alongside a future iOS update. The service would give users tips on diet and exercise, using data from the Health app and Apple devices like the Apple Watch.

It’s still unclear whether this tool will act more like a real medical assistant or just a health and wellness coach. Gurman describes it as an “AI doctor service,” and the report says it’s being trained using real data from doctors and medical professionals. The service might be called Health Plus and could become a major part of Apple’s growing services business.

Amazon.com, Inc. (NASDAQ: AMZN) is pushing deeper into genAI itself, including testing health assistants with a chatbot tool focused on health and wellness, called Health AI, which can answer health and wellness questions, “provide common care options for health care needs,” and suggest products.

Already, Amazon’s shopping chatbot, Rufus, can suggest products like ice packs and ibuprofen. Where Health AI goes further will be in providing users with medical guidance and care tips, such as how to deal with flu or cold symptoms. Health AI also steers users to Amazon’s online pharmacy, along with clinical services offered by One Medical, the primary care provider it acquired for roughly $3.9 billion in 2022.

Spectral AI, Inc. (NASDAQ: MDAI) recently announced strong results from its Burn Validation Study, showing that its DeepView® System outperformed burn physicians in identifying non-healing tissue.

“We believe these are excellent results and we are thrilled with the analysis of our DeepView System in our Burn Validation Study,” said Dr J. Michael DiMaio, M.D. “The DeepView System exceeded our expectations in terms of predictive performance. Following the FDA’s review, if authorized by the agency, our hope is that this tool will provide an objective and immediate prediction of non-healing burn tissue to expedite patient care and reduce system costs across the board. We look forward to bringing this predictive diagnostic tool to the United States marketplace as soon as possible.”

The study, one of the largest of its kind in the U.S., demonstrated DeepView’s superior accuracy using AI and multispectral imaging to assess burn wounds on day one. The company plans to submit the data to the FDA by mid-2025, aiming for De Novo Clearance and rapid commercialization.

GE HealthCare Technologies Inc.  (NASDAQ: GEHC) recently unveiled its new Revolution™ Vibe CT system, featuring advanced AI-powered cardiac imaging that delivers fast, accurate scans—even in complex cases like atrial fibrillation or heavy coronary calcification. The system’s Unlimited One-Beat Cardiac imaging and AI-driven workflow aim to improve diagnostic speed, patient comfort, and operational efficiency across healthcare facilities.

“Expanding access to CCTA is crucial for managing the rising prevalence of CVD, ensuring timely and accurate diagnoses for a larger patient population,” shares Jean-Luc Procaccini, President and CEO, Molecular Imaging and Computed Tomography, GE HealthCare. “Our introduction of Revolution Vibe underscores our commitment to this mission. The system is designed to encourage the broader adoption of and access to cardiac imaging, combining advanced technology with AI-powered solutions to deliver fast, accurate diagnoses and a more comfortable patient experience. It is designed to empower healthcare providers to offer the highest quality care, even in the most challenging cases.”

With FDA-recommended CCTA adoption on the rise and cardiac disease still the leading global cause of death, Revolution Vibe is designed to expand access to life-saving imaging and reduce reliance on invasive procedures.

Source: https://equity-insider.com/2025/03/21/unlocking-the-trillion-dollar-ai-market-what-investors- need-to-know/ 

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Federal Court Issues Preliminary Injunction Against OpenAI, Sam Altman, and Sir Jony Ive; iyO Alleges Trade Secret Theft by Altman’s Hardware Chief

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SAN FRANCISCO, April 27, 2026 /PRNewswire/ — On Thursday, April 23, 2026, the U.S. District Court for the Northern District of California granted iyO Inc. a preliminary injunction against OpenAI, Sam Altman, Sir Jony Ive, and io Products. The ruling, where the Court found that iyO was likely to succeed on the merits of its trademark claim, officially bars the defendants from using the “io” name for their hardware while iyO’s federal lawsuit proceeds.

Federal court bars OpenAI, Sam Altman, and Jony Ive from using ‘io’ name as iyO alleges trade secret theft.

Amended Complaint: Trade Secret Theft and Corporate Espionage
The ruling caps a year of escalating legal action. On March 13, 2026, iyO amended its federal complaint to include trade secret theft claims against the defendants and Tang Yew Tan — former Apple VP of Product Design, co-founder of io Products, and current Chief Hardware Officer at OpenAI.

The amended complaint outlines a highly coordinated timeline of alleged misappropriation:

May 2024: Just 11 days after iyO’s viral TED talk was published, Tan pre-ordered the iyO One. Nine days later, he contacted iyO’s Design and Manufacturing Lead, Dan Sargent, to schedule a dinner meeting for early June.

June 2024: Forensic analysis of Sargent’s company laptop revealed that in the days leading up to the dinner with Tan, Sargent downloaded 33 highly secret files, accessed dormant intellectual property folders, and exported 17 CAD files into cross-platform formats unused by iyO. These files were renamed with obfuscated strings (e.g., “grgrgege.x_t”) and exported outside of business hours. Sargent has since admitted to bringing iyO prototypes to show Tan.

May 2025: Barely 11 months after the dinner, OpenAI announced a $6.5 billion acquisition of io Products, a company built on what iyO alleges is its proprietary technology.

Following the acquisition announcement, iyO CEO Jason Rugolo confronted OpenAI CEO Sam Altman, who refused to cease use of the “io” name and threatened to sue Rugolo for using iyO’s own federally registered trademark.

Statement from iyO Leadership
“Sam, Jony, and Tang investigated us,” said Jason Rugolo, founder and CEO of iyO. “Then targeted us opportunistically, trying to eliminate us with a fancy $6.5 billion press release during our fundraise using a copy of our name. This week, a federal judge said: not so fast.”

iyO’s lawsuit asserts nine causes of action, including trade secret misappropriation, trademark infringement, intentional interference, and unfair competition. The company is seeking injunctive relief, compensatory and exemplary damages, disgorgement of profits, and a constructive trust over any portion of the $6.5 billion acquisition value attributable to the alleged stolen intellectual property and brand infringement.

ABOUT IYO
iyO began its mission inside Google X in 2018 to make natural language computing as commonplace as cellular phones. Spinning out as an independent venture-backed startup in 2021, iyO developed the iyO One, the iyO yO, and the recently announced iyO Wand, which are revolutionary screenless computer form factors that allow users to interact with AI and the internet through voice alone. iyO is headquartered in Redwood City, CA.

WEBSITE
www.iyo.ai 

IYO INC.
2606 SPRING STREET
REDWOOD CITY, CA 94063
UNITED STATES

ALL RIGHTS RESERVED
©2026 IYO INC.

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SOURCE iyO, Inc.

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Pudu Robotics Inaugurates U.S. Headquarters in Dallas, Accelerating Long-Term Growth in the Americas

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DALLAS, April 27, 2026 /PRNewswire/ — Pudu Robotics, a global leader in commercial service robotics, officially opened a new U.S. headquarters in Dallas, Texas, on April 23 as part of its global strategic expansion. The new facility is set to enhance Pudu’s regional capabilities and underscores the company’s long-term commitment to the Americas, marking a new phase of scaled, structured business development.

Dallas Unlocks Greater Efficiency and Regional Coordination

As a central hub for nationwide and cross regional operations across the Americas, Dallas brings strong strategic advantages. The area offers well-developed logistics and supply chain infrastructure, a business friendly environment, and access to a broad base of enterprise customers. Its central location will allow Pudu more efficient coverage across both North America and South America. As Pudu transitions into a phase of rapid, scalable growth in the Americas, its new centralized headquarters, which is located in Richardson’s Sherman Tech Center and combines a modern office space, product showroom, and on site warehousing, will enhance support management, operations, and long term regional coordination.

Meanwhile, as part of its broader infrastructure optimization, the company has also transitioned its Santa Clara office into a streamlined logistics support function outpost and established a dual warehouse system on both coasts to support nationwide delivery in the U.S.

Pudu in the Americas – A Growing Footprint Across Diverse Industries

Since entering the U.S. market in 2018, Pudu has steadily expanded its footprint across the Americas to a point of deep, localized operations. To date, nearly 15,000 Pudu robots have been deployed across the Americas, driving regional revenue growth of 285% year over year, bringing the company to a phase of large scale commercialization.

This rapid adoption is fueled by Pudu’s comprehensive product matrix, which addresses the specific labor and efficiency needs of the American market across four core categories:

Service Delivery: Led by the industry-favorite BellaBot and the newly enhanced BellaBot Pro, which have become the gold standard for hospitality and retail interaction.Commercial Cleaning: Featuring the best-selling PUDU CC1 series, the PUDU MT1 series designed for large-scale dry cleaning, and the recently launched PUDU BG1 series—an AI-native large scrubber-dryer robot built for heavy-duty environments.Industrial Delivery: The PUDU T-series robots provide versatile logistics support with payload capacities ranging from 150kg to 600kg, streamlining warehouse and factory workflows.General embodied AI: Represented by the advanced PUDU D5 series, pushing the boundaries of how robots interact with and adapt to complex human environments.

Partnerships with local distributors have also accelerated, achieving 63.6% YoY growth, with a rapidly expanding client base across diverse industries, including food and beverage, healthcare, industrial logistics and warehousing, real estate and property services, retail, and entertainment, sports and more. The company’s robots have enjoyed strong adoption by global industry leaders, including Walmart, Accenture, NASA, Norwegian Cruise Line, Honeywell, top automotive brands, and others.

This growth is matched by organizational development. Since entering the U.S. market in 2018, a initial team has flourished into a multi functional organization of professionals, with localized sales, after sales service, solutions, and marketing capabilities that enable stronger customer support and execution.

Building a Global Future Based on a Strategy of Localization

Looking ahead, Pudu will continue expanding its presence across key sectors including retail, logistics, food service, healthcare, and commercial cleaning, while bringing its service delivery, commercial cleaning, industrial delivery, and general embodied AI robotics solutions into broader industry scenarios.

“We are building for the long-term in the Americas with a localized approach,” said Raymond Pan, General Manager of the Americas at Pudu Robotics. “Our ambition over the next five years is to serve one million people across the U.S . Our new headquarters and infrastructure optimization provide a foundation for this ambition, alongside continuing investment in localized products, enhancing our local supply chain, and strengthening our partner ecosystem.”

Pudu has established itself as a global leader in service robotics, with more than 120,000 units shipped worldwide, operations spanning over 80 countries and regions, and 23% market share in commercial service robotics—ranking No. 1 globally per Frost & Sullivan’s “Market Research on Global Commercial Service Robotics (2023)”. Going forward, Pudu will accelerate its development and localization efforts across the Americas, while, at the same time, continuing to scale its presence in other key international markets as part of its global expansion strategy.

About Pudu Robotics

Pudu Robotics, a global leader in the commercial service robotics, committed to establishing a global intelligent robotics infrastructure that will serve 10 billion people worldwide.

Pudu Robotics has achieved full-stack proprietary R&D in core technologies, including navigation algorithms, multi-robot scheduling, swarm control, motion controllers, and integrated joint modules. Built on three core technologies—Embodied Navigation, Embodied Manipulation, and Embodied Interaction—Pudu Robotics has pioneered an “One Brain, Multiple Embodiments” architecture, establishing a comprehensive product portfolio that includes specialized, semi-humanoid, and humanoid robots.

Currently, Pudu offers four major product lines: service delivery, commercial cleaning, industrial delivery and general embodied AI. Its solutions are widely deployed across industries such as retail, hospitality, manufacturing, real estate and property services, healthcare, entertainment and sport, education, and public services.

To date, Pudu Robotics has shipped over 120,000 units globally, with a presence in more than 80 countries and regions.

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KuCoin Hosts HEXAGON BLOCK PARTY at Hong Kong Web3 Festival, Headlined by DJ Don Diablo and Rooted in Shared Values of Community and Connection

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Headlined by internationally renowned DJ Don Diablo, the event brought together guests from the Web3 and fintech communities for an immersive evening experience.

PROVIDENCIALES, Turks and Caicos Islands, April 27, 2026 /PRNewswire/ — KuCoin, a leading global crypto platform built on trust, and the exclusive Crypto Exchange and Payments Partner for Tomorrowland Winter and Tomorrowland Belgium (2026-2028), brought the spirit of global electronic music culture to Asia with the HEXAGON BLOCK PARTY in Hong Kong on April 22, which it co-hosted with Finoverse.

Headlined by internationally renowned DJ Don Diablo, the event welcomed guests from across the Web3, fintech, and broader innovation communities, creating an immersive gathering shaped by shared energy, conversation, and in-person connection. Building on KuCoin’s recent Tomorrowland Winter activation, which highlighted a shared belief that trust can be strengthened through community, creativity, and cultural experience, the event carried that momentum forward in Hong Kong through a similar spirit of openness, energy, and human connection. 

Held in the heart of Hong Kong, HEXAGON BLOCK PARTY was designed as more than an evening celebration. By combining world-class music with a culturally driven atmosphere, the event offered a welcoming space for founders, builders, creators, and community participants to come together in a more human and experience-led setting. It reflected a shared belief that meaningful community is built not only through ideas and technology, but also through moments of creativity, openness, and collective experience.

The event aimed to create a cultural touchpoint in Hong Kong that resonated beyond the venue itself. The event served as a space where ideas, creativity, and communities could converge, bringing together guests across Web3, fintech, and digital culture through a shared experience rooted in openness, energy, and connection.

As the global partnership between KuCoin and Tomorrowland continues, the journey moves forward to Tomorrowland Belgium in July 2026, where KuCoin will once again collaborate with Tomorrowland to create new experiences at the intersection of music, culture, and Web3, further expanding the role of digital assets in real-world cultural moments.

About KuCoin

Founded in 2017, KuCoin is a leading global crypto platform built on trust and security, serving over 40 million users across 200+ countries and regions. Known for its reliability and user-first approach, the platform combines advanced technology, deep liquidity, and strong security safeguards to deliver a seamless trading experience. KuCoin provides access to 1,500+ digital assets through a broad product suite and remains committed to building transparent, compliant, and user-centric digital asset infrastructure for the future of finance, backed by SOC 2 Type II, ISO/IEC 27001:2022, and ISO/IEC 27701:2019 Certifications. In recent years, we have built a strong global compliance foundation, marked by key milestones including AUSTRAC registration in Australia, a MiCA license in Europe, and regulatory progress in other markets. 

Learn more at www.kucoin.com.

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SOURCE KuCoin

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