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

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1 year ago

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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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HelloNation Article Highlights Sterile Compounding and Medication Safety With Insights From Compounding Pharmacist Expert Laura Temple

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31 minutes ago

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July 21, 2026

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The article explains how sterile compounded medications are prepared to reduce the risk of contamination and support safe, customized treatments.

AZLE, Texas, July 21, 2026 /PRNewswire/ — What does sterile compounding mean for medication safety? HelloNation has published an article explaining how sterile compounding helps pharmacies prepare highly specialized medications while adhering to strict contamination-prevention procedures.

The article features insights from Laura Temple, Compounding Pharmacist Expert and Owner of Laura’s Pharmacy in Azle, Texas. It explains that sterile compounding is a specialized process for preparing medications in carefully controlled environments designed to reduce the risk of contamination. Sterile compounded medications are often used for injections, eye drops, IV medications, and other therapies that require the highest levels of cleanliness and precision.

The HelloNation article explains that sterile compounded medications differ from commercially manufactured drugs because they are prepared individually for a patient’s unique medical needs. Physicians may prescribe compounded prescriptions when a patient requires a customized dosage, a combination medication, or a treatment not commercially available. Because these medications often bypass the body’s natural defenses, medication safety depends on strict preparation standards throughout the compounding process.

The article describes how pharmacies that provide sterile compounding rely on cleanroom environments equipped with filtered-air systems, specialized equipment, and contamination-prevention protocols. Pharmacists and technicians follow detailed gowning, sterilization, and handwashing procedures before handling medication ingredients. These measures are designed to support medication safety by limiting exposure to bacteria, particles, and other contaminants.

According to the article, environmental monitoring also plays a critical role in sterile compounding. Temperature control, air quality testing, and routine equipment inspections help maintain consistent preparation standards. The article notes that sterile compounded medications may undergo additional quality assurance checks before being dispensed to patients. These procedures help support both treatment effectiveness and patient safety.

The HelloNation article also explains that pharmacies performing sterile compounding are expected to follow USP guidelines established for sterile preparation. These USP guidelines outline requirements for cleanroom pharmacy operations, environmental testing, employee training, and quality assurance practices. The article emphasizes that maintaining compliance with USP guidelines helps reinforce contamination prevention and consistent preparation standards for compounded prescriptions.

Patients seeking sterile compounded medications may also look for pharmacies that participate in accreditation programs or are overseen by state boards. The article explains that these programs review safety procedures, documentation practices, and facility standards to help maintain medication safety. Regular environmental monitoring and staff competency evaluations are also identified as important safeguards in sterile compounding operations.

The article further explains that communication between pharmacists, healthcare providers, and patients remains an important part of safe compounded prescriptions. Compounding pharmacists review prescriptions carefully, confirm dosing instructions, and evaluate ingredient compatibility before preparation begins. This collaborative approach supports medication safety by reducing the risk of errors and ensuring treatments meet individual patient needs.

The article concludes that sterile compounding continues to play an important role in healthcare, particularly for patients requiring customized therapies that are unavailable through traditional manufacturing channels. Whether preparing IV medications, injectable therapies, or other sterile compounded medications, pharmacies rely on contamination prevention procedures and strict preparation standards to support patient care. The article notes that understanding how sterile compounding works can help patients feel more informed about the safety measures involved in preparing specialized medications.

What Sterile Compounding Means for Medication Safety features insights from Laura Temple, a compounding pharmacist expert at Laura’s Pharmacy in Azle, Texas, on HelloNation.

About HelloNation

HelloNation is America’s Good News Network, a premier media platform built on the idea that good news travels faster when real people tell real stories. Through its community-focused publications and innovative “edvertising” approach, HelloNation delivers content that informs, inspires, and spotlights the leaders making a meaningful impact in their communities.

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SOURCE HelloNation

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CIOs Forced to Rethink Manual Compliance Processes as Regulatory Complexity Rises, Says Info-Tech Research Group

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31 minutes ago

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July 21, 2026

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Regulatory demands are increasing in volume, complexity, and speed, leaving many organizations reliant on fragmented, manual approaches that slow response times and increase risk. New insights from Info-Tech Research Group show that organizations need to adopt more structured and scalable approaches to keep pace with regulatory change. The firm’s recently published blueprint, Build a Regulatory IT Response Engine, provides frameworks, tools, and step-by-step guidance to help organizations translate regulatory requirements into actionable IT controls and prioritized initiatives.

ARLINGTON, Va., July 21, 2026 /PRNewswire/ — Growing regulatory pressure across jurisdictions is forcing organizations to rethink how they interpret, prioritize, and execute compliance requirements. Many IT teams continue to operate with inconsistent processes and limited coordination, resulting in delayed initiatives and increased exposure to financial and reputational risk. Info-Tech’s blueprint, Build a Regulatory IT Response Engine, introduces a coordinated and repeatable approach to help IT leaders operationalize compliance and improve execution outcomes.

Info-Tech’s findings indicate that while organizations recognize the need for faster and more consistent regulatory response, they continue to face barriers such as fragmented interpretation of requirements, weak prioritization, and limited scalability. AI-enabled tools can help streamline analysis and accelerate response planning, but without a coordinated approach grounded in governance and human oversight, those benefits are difficult to realize.

“Regulatory response is becoming too complex to manage through disconnected, manual processes,” says Ahmad Jowhar, senior research analyst at Info-Tech Research Group. “IT leaders need a repeatable way to interpret requirements, prioritize action, and use AI to accelerate planning without losing the governance and oversight needed to execute effectively.”

Key Challenges IT Leaders Face in Regulatory Response

Despite ongoing investments in compliance, organizations continue to face systemic challenges that hinder effective execution. Info-Tech’s blueprint highlights several areas where IT and compliance leaders struggle most:

Fragmented and manual processes that slow regulatory interpretation and response.Inconsistent application of regulatory requirements across teams and jurisdictions.Poor prioritization of IT initiatives, leading to missed deadlines and duplicated effort.Limited scalability to manage increasing regulatory volume and complexity.Misalignment between compliance activities and broader business priorities.

Info-Tech’s Framework for Building a Regulatory IT Response Engine

To address these challenges, Info-Tech recommends a structured, AI-enabled approach that improves consistency, speed, and scalability. The firm’s Build a Regulatory IT Response Engine blueprint outlines the following key priorities for IT leaders:

Define the regulatory landscape: Establish organizational context, governance structures, and a centralized inventory of applicable regulations.Translate requirements into IT controls: Use AI-enabled analysis and structured assessments to convert regulatory obligations into actionable controls.Prioritize IT initiatives: Align initiatives based on cost, effort, impact, and regulatory timelines to reduce execution risk.Build and communicate a roadmap: Develop a clear, resource-aligned roadmap to guide execution and stakeholder alignment.Establish a repeatable process: Continuously monitor, adapt, and refine regulatory response capabilities to maintain compliance over time.

Organizations that adopt this structured approach can move from reactive compliance efforts to a more proactive and scalable model that shortens response timelines, reduces manual effort, and strengthens execution.

The firm’s Build a Regulatory IT Response Engine blueprint includes practical tools such as a Regulation Inventory Tool, a Regulatory Response IT Action Plan Tool, a Communication Deck Template, and a Compliance Program Framework. By applying these resources, IT leaders can standardize regulatory responses, improve prioritization, and help ensure compliance initiatives are executed on time and in alignment with business priorities.

For exclusive and timely commentary from Info-Tech’s experts, including Ahmad Jowhar, and access to the complete Build a Regulatory IT Response Engine blueprint, please contact pr@infotech.com.

About Info-Tech Research Group

Info-Tech Research Group is the “get things done” partner for over 30,000 IT, HR, and marketing leaders worldwide. The fastest growing research and advisory firm, Info-Tech enables leaders to make well-informed decisions and transform their organizations through AI, strategic foresight, step-by-step methodologies, practical tools, industry-leading advisory, and training programs. For nearly 30 years, tens of thousands of private and public organizations have trusted Info-Tech to lead their most important initiatives through periods of change and deliver outcomes that truly matter.

To learn more about Info-Tech’s HR research and advisory services, visit McLean & Company, and for data-driven software buying insights and vendor evaluations, visit the firm’s SoftwareReviews platform.

Media professionals can register for unrestricted access to research across IT, HR, and software and hundreds of industry analysts through the firm’s Media Insiders program. To gain access, contact pr@infotech.com.

For information about Info-Tech Research Group or to access the latest research, visit infotech.com and connect via LinkedIn and X.

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SOURCE Info-Tech Research Group

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Atomera to Announce Second Quarter 2026 Financial Results and Host Webinar on Tuesday, August 4, 2026

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31 minutes ago

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July 21, 2026

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LOS GATOS, Calif., July 21, 2026 /PRNewswire/ — Atomera Incorporated (NASDAQ: ATOM), a semiconductor materials and technology licensing company, announced today that it plans to release its second quarter 2026 financial results after the market closes on Tuesday, Aug. 4, 2026.

The company will host a live video Zoom webinar at 2:00 p.m. Pacific Time (5:00 p.m. Eastern Time) on Tuesday, Aug. 4, 2026, to discuss the results. The live webinar can be accessed through Atomera’s investor relations website at https://ir.atomera.com. A replay of the webcast will be available for 12 months. To pre-register for the webinar, use the following link.

https://atomera.zoom.us/webinar/register/WN_OJFbTWe1SIyV69LLdDadCw

About Atomera

Atomera Incorporated is a semiconductor materials and technology licensing company focused on deploying its proprietary, silicon-proven technology into the semiconductor industry. Atomera has developed Mears Silicon Technology™ (MST®), which increases performance and power efficiency in semiconductor transistors. MST can be implemented using equipment already deployed in semiconductor manufacturing facilities and is complementary to other nano-scaling technologies already in the semiconductor industry roadmap.  More information can be found at www.atomera.com 

 

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SOURCE Atomera Incorporated

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