Connect with us

Technology

Following Pivotal Trial, FDA Set to Review First-of-a-Kind VR Autism Therapy

Published

on

WASHINGTON, April 20, 2026 /PRNewswire/ — Floreo, a developer of virtual reality (VR)-based therapeutic technologies, today announced the submission of a De Novo request to the U.S. Food and Drug Administration (FDA) for FloreoRx, its software-based product being evaluated for use in supporting skill development in individuals with Autism Spectrum Disorder. FloreoRx is an investigational device and has not yet been cleared or approved by the FDA.

In 2023, Floreo became the first VR autism technology to receive the FDA’s Breakthrough Device Designation, a program designed to expedite the development and review of technologies that may provide more effective treatment for serious conditions.

For many families and clinicians, access to consistent, high-quality autism therapy remains a persistent challenge. If authorized, FloreoRx could become one of the first FDA-authorized therapeutic devices intended to address core social communication challenges associated with Autism Spectrum Disorder. Using a VR headset and FloreoRx, behavioral therapists deliver structured experiences that enable users to safely develop and practice social communication skills through real-world scenarios and interactions.

The submission is supported by data from Floreo’s pivotal trial which utilized FloreoRx within Applied Behavioral Analysis (ABA) autism therapy evaluated against an active VR sham control. The study was 100% monitored and among the largest prospective, multi-site randomized controlled trials of a VR-based intervention conducted in children with autism.

The pivotal trial was conducted in partnership with Cortica Healthcare (Cortica) across 18 clinical sites nationwide, leveraging Cortica’s gold-standard integrated autism care model. Additionally, MCRA served as CRO and Highland BioMed provided strategic regulatory assistance with the preparation of the De Novo submission.

The trial focused on core social communication challenges associated with Autism Spectrum Disorder, assessed using the Autism Impact Measure (AIM). At clinically interpretable thresholds of improvement, participants receiving Floreo treatment demonstrated higher responder rates than those in the VR control group (e.g., 45.6% vs. 23.3%), with statistically significant differences between groups. These results were supported by consistent improvements across clinician-rated and functional measures.

Importantly, this trial also reflects the scale and operational capacity required to generate meaningful results in real-world care settings. Cortica enrolled 125 patients and coordinated more than 150 behavioral technician VR coaches and 15 blinded assessors across all sites involved in the study over a 15-month period, spanning both blinded therapy delivery and crossover.

“The clinical research continues to validate what clinicians and families are seeing every day: immersive VR can meaningfully support skill development for autistic learners,” said Vijay Ravindran, founder and CEO of Floreo. “Three things stand out in the trial: 1) That Floreo could achieve statistically significant results with a dosage of 18 minutes per week over 12 weeks, 2) That Floreo performed better as the severity of symptoms increased, and 3) that improvements continued to strengthen after 60 days.”

Clinical Highlights Include:

Social Skills: Clinician-administered CARS-2 evaluations showed a statistically significant LSMean change of -4.5 for the Floreo group versus -2.2 for the control (p = .0182).Subgroup Analysis (Highest-Burden Baseline): Participants in the highest-burden tertile at baseline demonstrated a 72% responder rate compared to 30% in the control group (p=0.009).Post-Treatment Observation: Improvements observed in AIM scores for the FloreoRx group at the 12-week end-of-treatment mark were sustained at the 60-day follow-up evaluation.High Skill Mastery: A majority of participants (95.1%) mastered one or more new skills by the end of treatment, as measured by the Assessment of Functional Living Skills.Family Quality of Life: Caregiver-reported CFQL-2 reports on family quality of life showed a between groups difference that was statistically significant for the Floreo group versus the control of 0.152 (p = 0.032).Crossover Findings: Participants who initially received the VR control demonstrated improvements after transitioning to Floreo treatment, supporting the consistency of the observed treatment effect.Safety Profile: No serious adverse events were reported in the study, and observed adverse events were generally mild and transient.High Engagement and Satisfaction Across Stakeholders: High levels of satisfaction were reported across clinicians and caregivers, including clinician-reported enjoyment of VR (98%) and willingness to use it as a treatment tool (88%), as well as parent-reported child enjoyment (93%) and interest in using VR as part of therapy (86%).

If authorized, Floreo intends to make FloreoRx available as an adjunct to existing therapeutic approaches, with the goal of expanding access to structured, skills-based interventions for the approximately 3% of children in the United States diagnosed with Autism Spectrum Disorder, where access to consistent, high-quality therapy remains a significant challenge.

Floreo currently offers a commercially available VR platform designed for general wellness and skills development that does not make medical or therapeutic claims. FloreoRx is a separate investigational product under FDA review.

About Floreo
Floreo’s vision is a world that is open and accessible for every neurodiverse person. Through immersive virtual reality experiences, Floreo creates safe, engaging environments where learners can build skills and tools they can apply in their everyday lives. Floreo’s virtual reality platform teaches social, behavioral, communication, and life skills for individuals with Autism Spectrum Disorder and other neurodiverse conditions. For more information, please visit floreovr.com.

View original content to download multimedia:https://www.prnewswire.com/news-releases/following-pivotal-trial-fda-set-to-review-first-of-a-kind-vr-autism-therapy-302746375.html

SOURCE Floreo

Continue Reading
Click to comment

Leave a Reply

Your email address will not be published. Required fields are marked *

Technology

Broadridge Announces Strategic Investment in CENTRL to Enhance Due Diligence and RFP Solutions for Asset Management and Retirement Industry

Published

on

By

NEW YORK and LONDON, April 20, 2026 /PRNewswire/ — Broadridge Financial Solutions, Inc. (NYSE: BR), a global Fintech leader, today announced a strategic partnership and minority investment in CENTRL, a leading provider of AI-powered due diligence solutions for financial institutions. The partnership enhances Broadridge’s data and analytics solutions for the asset management and retirement advisory industries with leading due diligence technology and expands its AI-enabled capabilities, helping modernize counterparty due diligence and RFP processes through data-driven, innovative technology.

“This partnership represents an important step in expanding our AI-enabled capabilities and delivering greater value for clients across our platform,” said Dan Cwenar, President, Data-Driven Fund Solutions at Broadridge. “By combining Broadridge’s deep industry relationships and data assets with CENTRL’s purpose-built AI technology, we are helping clients modernize due diligence and RFP response workflows, improve operational efficiency and better manage risk, and accumulate more assets.”

The financial services industry continues to face increasing regulatory scrutiny, fragmented counterparty oversight processes and a growing volume of manual and duplicative due diligence requests. By integrating Broadridge’s trusted data and market infrastructure capabilities with CENTRL’s AI-driven due diligence platform, firms can reduce manual touchpoints, eliminate redundant data gathering, improve accuracy and consistency, and strengthen regulatory audit trails.

“Broadridge is a trusted partner to many of the world’s leading financial institutions,” said Sanjeev Dheer, Founder and Chief Executive Officer of CENTRL. “Together, we are bringing AI-driven intelligent automation to some of the industry’s most complex and resource-intensive processes. By embedding AI directly into due diligence, research, and DDQ/RFP response and communication workflows, we can help firms move from manual, fragmented processes to streamlined, data-driven operations.”

Through the partnership, Broadridge will integrate CENTRL’s AI-powered workflow and automation capabilities across solutions serving asset managers, retirement recordkeepers, and retirement advisors. The collaboration includes modernizing Broadridge’s Fi360 RFP Director, embedding Broadridge data into CENTRL’s workflows, and expanding access to AI-driven tools that automate due diligence, RFP responses, and counterparty oversight processes.

Broadridge’s data and analytics business is focused on transforming complex data into actionable insights across the asset management lifecycle—from distribution and investor behavior to operational performance. The integration of CENTRL’s AI-powered due diligence capabilities extends this strategy, connecting data, workflows and automation to help clients streamline counterparty oversight and RFP processes. Together, Broadridge and CENTRL deliver a more unified, data-driven solution that improves efficiency, enhances decision-making and supports asset managers in scaling their businesses.

Additionally, Broadridge clients will now have access to CENTRL’s leading due diligence management and response platforms, including deeper integration with Broadridge’s leading distribution data and analytics, enabling asset managers to improve and scale due diligence, fund and counterparty oversight, and RFP response workflows.

About Broadridge
Broadridge Financial Solutions (NYSE: BR) is a global technology leader with trusted expertise and transformative technology, helping clients and the financial services industry operate, innovate, and grow. We power investing, governance, and communications for our clients – driving operational resiliency, elevating business performance, and transforming investor experiences.

Our technology and operations platforms process and generate over 7 billion communications annually and underpin the daily average trading of over $15 trillion in tokenized and traditional securities globally. A certified Great Place to Work®, Broadridge is part of the S&P 500® Index, employing over 15,000 associates in 21 countries.

For more information, visit www.broadridge.com.

About CENTRL
CENTRL is a Silicon Valley-based technology firm offering an AI-powered Diligence and Response platform for the financial services industry. CENTRL helps Asset Allocators, Asset Managers, Banks, and Service providers automate their diligence, research, and DDQ/RFP response processes with a domain-specific AI platform. CENTRL’s clients include 8 of the top 30 global banks and leading Asset Allocators and Asset Managers across the Americas, Europe, the UK, and Australia.

Media contacts:

Linda Namias
Linda.namias@broadridge.com
631-254-7711

Alice Stephens
Astephens@centrl.ai
414-403-1172

 

View original content to download multimedia:https://www.prnewswire.com/news-releases/broadridge-announces-strategic-investment-in-centrl-to-enhance-due-diligence-and-rfp-solutions-for-asset-management-and-retirement-industry-302746279.html

SOURCE Broadridge Financial Solutions, Inc.

Continue Reading

Technology

HONEYWELL TO SELL PRODUCTIVITY SOLUTIONS AND SERVICES BUSINESS TO BRADY CORPORATION

Published

on

By

Accelerates portfolio simplification as Honeywell prepares for the planned spin-off of its Aerospace business, on track for Q3 2026

CHARLOTTE, N.C., April 20, 2026 /PRNewswire/ — Honeywell (Nasdaq: HON) today announced that it has agreed to sell its Productivity Solutions and Services (“PSS”) business to Brady Corporation, an international manufacturer of identification and protection solutions, for $1.4 billion in an all-cash transaction. The transaction is expected to be completed in the second half of 2026 and is subject to regulatory approvals and customary closing conditions.

The transaction follows the review of strategic alternatives Honeywell commenced in July 2025 for PSS and its Warehouse and Workflow Solutions (“WWS”) business to further simplify the company’s portfolio alongside the planned spin-off of its Aerospace business, which is expected to be complete in the third quarter of 2026. Honeywell remains actively engaged in its assessment of strategic alternatives for WWS, which operates commercially under the brand names Intelligrated and Transnorm.

“With the PSS divestiture, we are nearing completion of our multi-year portfolio transformation, further accelerating value creation as we prepare to separate our Aerospace and Automation businesses into two independent industry leading public companies. The sale also enables us to continue strengthening our financial and operational focus on the company’s core businesses,” said Vimal Kapur, Chairman and CEO of Honeywell.

“Going forward, PSS will benefit from Brady’s highly complementary and specialized leadership in industrial identification and safety, creating a broader, more integrated offering for warehouse, logistics and manufacturing customers,” Kapur added.

With 2025 revenue of approximately $1.1 billion, PSS is a leading provider of mobile computers, barcode scanners and printing solutions serving the warehouse and logistics market. PSS is currently part of Honeywell’s Industrial Automation (IA) business portfolio.

Brady Corporation (NYSE: BRC) is an international manufacturer and marketer of high-performance labels, signs, safety devices and printing systems for industries that include electronics, manufacturing and aerospace. Brady provides products that enhance safety, security and productivity. The acquisition of PSS will help build Brady’s capabilities in data capture, mobile computing and workflow automation, increasing its portfolio serving industrial and logistics customers, while creating a more integrated, end‑to‑end productivity and safety platform.

This announcement follows the divestiture of Honeywell’s Personal Protective Equipment (PPE) business in 2024 and the spin-off of its Advanced Materials business as Solstice Advanced Materials (Nasdaq: SOLS) in October 2025. It also builds on the prior strategic actions Honeywell has taken to drive organic growth and optimize its portfolio, including announcing approximately $14 billion of accretive and synergistic acquisitions since 2023: Compressor Controls Corporation, SCADAfence, the Access Solutions business from Carrier Global, Civitanavi Systems, CAES Systems, the LNG business from Air Products, Sundyne, Li-ion Tamer and Johnson Matthey’s Catalyst Technologies Business.

Centerview Partners is serving as financial advisor to Honeywell. Kirkland & Ellis LLP,  Baker McKenzie and Womble Bond Dickinson are providing external legal counsel.

About Honeywell 
Honeywell is an integrated operating company serving a broad range of industries and geographies around the world, with a portfolio that is underpinned by our Honeywell Accelerator operating system and Honeywell Forge platform. As a trusted partner, we help organizations solve the world’s toughest, most complex challenges, providing actionable solutions and innovations for aerospace, building automation, industrial automation, process automation, and process technology that help make the world smarter and safer as well as more secure and sustainable. For more news and information on Honeywell, please visit www.honeywell.com/newsroom.

Forward Looking Statement
We describe many of the trends and other factors that drive our business and future results in this release. Such discussions contain forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act), including statements related to the proposed separation of Honeywell from Honeywell Aerospace and the planned sale of the Productivity Solutions and Services and Warehouse and Workflow Solutions businesses. Forward-looking statements are those that address activities, events, or developments that we or our management intend, expect, project, believe, or anticipate will or may occur in the future. They are based on management’s assumptions and assessments in light of past experience and trends, current economic and industry conditions, expected future developments, and other relevant factors, many of which are difficult to predict and outside of our control, including Honeywell’s current expectations, estimates, and projections regarding the proposed separation of Honeywell from Honeywell Aerospace and the planned sale of the Productivity Solutions and Services and Warehouse and Workflow Solutions businesses. They are not guarantees of future performance, and actual results, developments, and business decisions may differ significantly from those envisaged by our forward-looking statements, including the proposed separation of Honeywell from Honeywell Aerospace and the planned sale of the Productivity Solutions and Services and Warehouse and Workflow Solutions businesses, and the anticipated benefits of each. We do not undertake to update or revise any of our forward-looking statements, except as required by applicable securities law. Our forward-looking statements are also subject to material risks and uncertainties, including ongoing macroeconomic and geopolitical risks, such as changes in or application of trade and tax laws and policies, including the impacts of tariffs and other trade barriers and restrictions, lower GDP growth or recession in the U.S. or globally, supply chain disruptions, capital markets volatility, inflation, and certain regional conflicts, including ongoing conflicts in the Middle East, that can affect our performance in both the near- and long-term. In addition, no assurance can be given that any plan, initiative, projection, goal, commitment, expectation, or prospect set forth in this release can or will be achieved. These forward-looking statements should be considered in light of the information included in this release, our Form 10-K, and our other filings with the Securities and Exchange Commission. Any forward-looking plans described herein are not final and may be modified or abandoned at any time.

Contacts:

Media         

Investor Relations

Stacey Jones           

Mark Macaluso

(980) 378-6258         

(704) 627-6118

Stacey.Jones@honeywell.com          

mark.macaluso@honeywell.com

View original content to download multimedia:https://www.prnewswire.com/news-releases/honeywell-to-sell-productivity-solutions-and-services-business-to-brady-corporation-302747018.html

SOURCE Honeywell

Continue Reading

Technology

Identiv Expands ID-Safe NFC Tag Portfolio to Enable Secure Product Authentication, Tamper Detection, and Traceability

Published

on

By

Expanded portfolio of tamper-evident and tamper-proof NFC tags enables companies to verify authenticity, detect interference, and maintain product integrity across the lifecycle.

SANTA ANA, Calif., April 20, 2026 /PRNewswire/ — Identiv, Inc. (NASDAQ: INVE), a global leader in RFID- and BLE-enabled Internet of Things (IoT) solutions, today announced the expansion of its ID-Safe product family, a portfolio of advanced HF and NFC tags designed to support product authentication, tamper detection, and secure traceability across pharmaceutical, healthcare, retail, food and beverage, electronics, and smart packaging applications.

As companies work to address rising counterfeiting, diversion, and product fraud, there is growing demand for solutions that can verify product authenticity, confirm package integrity, and provide visibility across the product lifecycle.

Identiv’s ID-Safe portfolio addresses these challenges by combining NFC-based product identity with advanced tamper detection and secure authentication. By embedding secure NFC technology directly into tags, ID-Safe transforms product labeling into a digital trust layer – enabling companies to confirm that a product is genuine, verify that it has not been opened or altered, and enable secure digital interaction using standard NFC-enabled smartphones or readers.

“Trust in physical products can’t be assumed anymore – it has to be verified. ID-Safe brings together secure NFC-based identity, tamper detection, and tamper-proof design to enable companies to confirm authenticity and product integrity at any point in the lifecycle, anywhere those interactions occur,” said Andreas Walsner, Global Vice President Sales, Identiv. “It allows organizations to detect interference, prevent fraud, and establish trusted product identity anywhere it matters – from manufacturing through distribution to the point of use – while supporting secure, scalable deployment across real-world operations.”

A trusted, tamper-proof tag portfolio

The ID-Safe portfolio includes a range of NFC tag configurations designed to support diverse applications across pharmaceutical, healthcare, retail, food and beverage, electronics, and smart packaging environments. These include tamper-evident NFC labels that detect and record package opening events, as well as tamper-proof tags with destructible antennas that prevent removal, reuse or product refilling. Select configurations support encrypted authentication using high-security NFC chips, enabling protection against cloning and advanced counterfeiting.

Each ID-Safe tag is encoded with a unique identity and can be linked to cloud-based systems, creating a digital twin of the product. Throughout manufacturing, logistics, and distribution, stakeholders can scan the tag to confirm authenticity and verify that the product remains unopened. Once a package is opened or tampered with, the tag registers an irreversible state change – such as a broken antenna or altered electrical signal – clearly indicating that the product has been compromised.

The ID-Safe product family is designed to help organizations address critical product security challenges, including counterfeiting, gray market diversion, warranty and returns abuse, and product refilling and resale fraud. By making product authenticity and integrity verifiable in real time, ID-Safe helps protect brand value, improve recall and compliance processes, and strengthen trust across the supply chain and with end users.

The products are already deployed in an award-winning NFC-based anti-counterfeiting smart packaging solution for luxury wine producers and collectors, developed in collaboration with ZATAP and Genuine-Analytics.

The ID-Safe portfolio includes multiple configurations with options for different chip types, memory capacities, and form factors.

“Companies can’t afford uncertainty when it comes to product authenticity and integrity. ID-Safe provides a practical way to verify products, detect tampering, and prevent fraud – including refilling, diversion, and unauthorized resale – while enabling secure interaction throughout the product lifecycle. It’s a critical step toward making physical products more secure, traceable, and trusted,” concluded Walsner.

For more information about Identiv’s ID-Safe product family or other IoT solutions, please visit our Product Finder or contact sales@identiv.com

About Identiv
Identiv’s RFID- and BLE-enabled IoT solutions create digital identities for physical objects, enhancing global connectivity for businesses, people, and the planet. Its solutions, integrated into over 2.0 billion applications worldwide, drive innovation across healthcare, logistics, consumer electronics, luxury goods, smart packaging, and more. For additional information, visit identiv.com | Follow us on LinkedIn @Identiv

Media Contact:
Samantha Bryton
samantha@griffin360.com

View original content:https://www.prnewswire.com/news-releases/identiv-expands-id-safe-nfc-tag-portfolio-to-enable-secure-product-authentication-tamper-detection-and-traceability-302746374.html

SOURCE Identiv

Continue Reading

Trending