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Endotronix Receives FDA Premarket Approval of the Cordella™ PA Sensor System for the Treatment of Heart Failure

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Cordella, which consists of the now PMA-approved Cordella PA Sensor and commercial Cordella™ HF System, enables comprehensive heart failure management in the home using pulmonary artery (PA) pressure, a leading indicator of congestion, and non-invasive vital sign data to improve care decisions.Backed by definitive clinical evidence from the PROACTIVE-HF pivotal trial, the company is planning a U.S. launch of Cordella this year.

NAPERVILLE, Ill., June 24, 2024 /PRNewswire/ — Endotronix, Inc., a privately held company dedicated to advancing the treatment of heart failure (HF) at the intersection of digital health and medtech, today announced Premarket Approval (PMA) from the U.S Food and Drug Administration (FDA) of the company’s Cordella™ Pulmonary Artery (PA) Sensor System for the treatment of New York Heart Failure (NYHA) class III heart failure patients. The Cordella platform is the first and only PA pressure-guided platform to offer comprehensive patient management using daily PA pressure and vital signs from home to guide therapeutic management and improve patient outcomes.

“This approval is very exciting and has the potential to transform care for HF patients. Endotronix’s solution provides a more complete clinical picture of the patient, so providers are able to make informed remote care decisions between office visits,” stated Dr. Liviu Klein, Section Chief of Advanced Heart Failure, Mechanical Circulatory Support, Pulmonary Hypertension, and Heart Transplant at the University of California San Francisco and national principal investigator of the PROACTIVE-HF trial. “PROACTIVE-HF demonstrated that with Cordella clinicians achieved more optimal and timely dosing of key HF medications, significantly improving outcomes. In addition, the easy-to-use platform engages patients to drive consistent daily habits and self-awareness of trends to support sustainable lifestyle changes.”

Cordella is a proactive HF management platform that delivers daily PA pressure and other vital data via an implantable sensor and user-friendly, non-invasive health tools, respectively, to a managing HF clinician for remote patient care. This information guides clinical decision-making and medication dosing while enhancing the adoption of guideline-directed medical therapy (GDMT) to reduce congestion and improve outcomes. Regulatory approval was based on the PROACTIVE-HF trial, which demonstrated a markedly low 0.159 rate of heart failure hospitalization and all-cause mortality at 6 months.

In addition, Cordella enables:

Seated PA pressure measurements, preferred by most patients, with a handheld reader.Patient visibility into key health trends to support healthy lifestyle changes.Secure messaging on a tablet between the clinical team, patient, and caregiver to support remote care.Reimbursement for implantation and ongoing management through existing reimbursement pathways.

“At Endotronix, we firmly believe that innovation can drive patient care excellence in the home and ultimately change outcomes for patients with heart failure, one of the largest cost categories in healthcare. The FDA’s approval validates this foundational belief and is a major milestone for our company and the field of HF management,” commented Harry Rowland, CEO and co-founder of Endotronix. “With this approval, we will deliver proactive, comprehensive care that extends optimal HF therapeutic management to more patients, keeping them out of the hospital and living more fulfilling lives.”

Endotronix will launch Cordella in the U.S. later this year. The company also shared that they have submitted a dossier for CE Mark review and expect a decision on European market access in 2025.

About Endotronix
Endotronix innovates at the intersection of medtech and digital health to improve care for people living with heart failure (HF). The comprehensive Cordella solution enables proactive, data-driven HF management that engages patients, reduces and prevents congestion, and improves outcomes. The Cordella Sensor is an implantable pulmonary artery (PA) pressure sensor that directly measures the leading indicator of congestion, allowing early, targeted therapy. The Cordella HF System is a patient health management platform, which combines comprehensive vital sign data from non-invasive devices to support patient-clinician engagement and care decisions. Combining trended insights, the versatile and scalable Cordella enhances current clinical practice and supports guideline-based care across the entire HF continuum. Learn more at www.endotronix.com.

In the U.S., the Cordella PA Sensor System is Rx Only. CAUTION: Federal law restricts this device to sale by or on the order of a physician.
In Europe, the Cordella PA Sensor System is Exclusively for Clinical Investigation.
The Cordella HF System is commercially available in the U.S. and Europe.

Cautionary Statement Regarding Forward-Looking Statements

This press release may contain predictions, estimates, or other information that might be considered forward-looking statements. Such forward-looking statements are not a guarantee of future performance.

 

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Invitation to Tecsys’ Conference Call on June 30, 2026, Covering Fourth Quarter and Fiscal Year 2026 Results

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MONTREAL, June 15, 2026 /CNW/ — Tecsys Inc. (TSX: TCS) will release its financial results for the fourth quarter and fiscal year 2026 ended April 30, 2026, on June 29, 2026, after the markets close. Tecsys President and CEO Peter Brereton, and CFO Mark J. Bentler, will host a conference call on June 30, 2026, at 8:30 a.m. ET to present and discuss the results with the analysts.

Subject: Q4 and FY2026 Financial Results Conference Call
Date: June 30, 2026
Time: 8:30 a.m. ET
Phone number: 1-800-836-8184 or 1-646-357-8785

The call can be replayed until July 7, 2026, by calling 1-888-660-6345 or 1-646-517-4150 (access code: 11868 #).

About Tecsys 

Tecsys is trusted by mission-critical organizations in healthcare and distribution to build resilient, efficient and secure supply chains. A global provider of cloud-based, AI-driven software with deep domain expertise, Tecsys delivers real-time operational visibility and execution across critical workflows when performance and reliability matter most. Tecsys is publicly traded on the Toronto Stock Exchange (TCS). For more information, visit www.tecsys.com

Forward Looking Statements

The statements in this news release relating to matters that are not historical fact are forward-looking statements that are based on management’s beliefs and assumptions. Such statements are not guarantees of future performance and are subject to a number of uncertainties, including but not limited to future economic conditions, the markets that Tecsys Inc. serves, the actions of competitors, major new technological trends, and other factors beyond the control of Tecsys Inc., which could cause actual results to differ materially from such statements. More information about the risks and uncertainties associated with Tecsys Inc.’s business can be found in the MD&A section of the Company’s annual report and the most recently filed annual information form. These documents have been filed with the Canadian securities commissions and are available on our website (www.tecsys.com) and on SEDAR+ (www.sedarplus.ca).

SOURCE Tecsys Inc.

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Quest Global Launches Neprion to Accelerate AI Smart Wearables Launch Readiness

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New engineering service package designed to help OEMs, retailers, and fashion brands ensure reliability, interoperability, safety, and launch readiness for AI-enabled smart wearables

BENGALURU, India and WINDSOR, Conn., June 16, 2026 /PRNewswire/ — Quest Global, the largest independent pure-play engineering services company, today announced the launch of Neprion (Next–Gen Product Realization), a framework-led product realization and system validation offering for AI/AR smart glasses and broader AI/AR/XR smart wearables.

Quest Global’s Neprion is designed to help OEMs, Tier–1 suppliers, and ecosystem partners accelerate validation, improve launch readiness, and deliver production-grade quality, safety, and interoperability for next-generation wearable devices.

As the global AR and VR market is projected to generate revenues of US$50.9 billion in 2026, driven by growing adoption of immersive technologies across consumer and enterprise applications, Neprion is helping customers across North America, Europe and APAC accelerate the development of AI/AR smart glasses. Designed for OEMs, fashion brands and retailers, the platform enables teams to move from prototype to market with confidence, transforming engineering complexity into predictable quality and on-time launch readiness through a single-partner execution model.

Commenting on the announcement, Tinku Jose, Head of Vertical Technology (Hi-Tech), Quest Global, said, “AI-enabled smart wearables are moving into the mainstream, and scale doesn’t reduce engineering risk it raises the bar for validation rigor, interoperability, AI accuracy, functional safety, and compliance readiness. With Neprion, we are packaging our product engineering depth and validation expertise into a scalable framework-led offering that helps customers accelerate launch readiness while improving product reliability and user trust.”

He added, “As the AI, AR, and XR ecosystem becomes more complex, organizations need engineering partners that can compress time-to-market without weakening quality controls. Neprion enables disciplined execution across hardware, embedded software, connectivity, and AI-enabled experiences helping customers scale innovation while maintaining product integrity and compliance readiness.”

Neprion is designed for device engineering leaders, Tier–1 suppliers, quality and validation leaders, and certification stakeholders seeking structured, scalable product and system validation for next-generation smart wearables.

The launch comes at a time when the AI/AR/XR smart wearables ecosystem is witnessing accelerated innovation, growing demand for interoperability across devices and platforms, and increasing focus on production-grade AI performance, compliance readiness, and seamless user experiences.

About Quest Global

At Quest Global, it’s not just what we do but how and why we do it that makes us different. We’re in the business of engineering, but what we’re really creating is a brighter future. For over 25 years, we’ve been solving the world’s most complex engineering problems. Operating in over 20 countries, with over 104 global delivery centers, our 23,000+ curious minds embrace the power of doing things differently to make the impossible possible. Using a multi-dimensional approach, combining technology, industry expertise, and diverse talents, we tackle critical challenges faster and more effectively. And we do it across the Aerospace & Defense, Automotive, Energy, Hi-Tech, MedTech & Healthcare, Rail and Semiconductor industries. For world-class end-to-end engineering solutions, we are your trusted partner.   

 

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Fortune Unveils 2026 Southeast Asia 500

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Trafigura Group tops the 2026 Fortune Southeast Asia 500 for the third consecutive year, with US$240.3 billion in revenue

Vietnam companies emerge as the ranking’s standout growth story, with aggregate revenue up 10.5% — triple the regional average

Revenue threshold to qualify for the 2026 Fortune Southeast Asia 500 jumps 26% to US$440.6 million

Two Singapore-based crypto-mining firms debut on the list

40 female CEOs on the list, including Fortune’s Most Powerful Woman in Asia, DBS CEO Tan Su Shan

SINGAPORE, June 16, 2026 /PRNewswire/ — Today, Fortune announced the Fortune Southeast Asia 500™ rankings for 2026, the third annual list of the largest companies in the region, ranked by revenue for the 2025 fiscal year.

Topping the 2026 Fortune Southeast Asia 500 for the third consecutive year is Singapore-headquartered commodity trader Trafigura Group (No. 1), with US$240.3 billion in revenue. It is followed by Thailand’s state energy company PTT (No. 2, US$81.0 billion), Indonesia’s Pertamina (No. 3, US$70.9 billion), Singapore-based agribusiness giant Wilmar International (No. 4, US$70.4 billion), and fellow Singapore company Olam Group (No. 5, US$51.5 billion). Three of the top five are headquartered in Singapore.

Vietnam was the ranking’s standout growth story. The country’s 72 companies generated US$177.9 billion in aggregate revenue, up 10.5% year-over-year — triple the regional average. Despite representing less than 10% of the overall revenue base, Vietnam’s companies contributed roughly a quarter of this year’s total revenue growth across the entire ranking.

Thailand leads all countries with 105 companies on the list, narrowly ahead of Indonesia’s 104. Singapore’s 82 companies generate the ranking’s highest aggregate national revenue at US$657.6 billion. Malaysia accounts for 93 companies, Vietnam 72, the Philippines 42 — up two from last year — and Cambodia 2.

Energy remained the dominant sector by revenue at 31.5% across 57 companies, led by the state-linked oil and gas majors that have anchored the list since its 2024 launch. Financials ranked second by company count with 76 companies, contributing 16.2% of revenue. Yet the story flips when considering profits: Energy players accounted for 15.7% of profits on the list compared to 43% for Financials. Among the 34 new entrants, Thailand added the most with nine, followed by Malaysia with eight; Financials and Engineering & Construction each contributed six.

The revenue threshold for the 2026 Fortune Southeast Asia 500 rose to US$440.6 million — 26% higher than last year’s. The 500 companies collectively generated US$1.878 trillion in revenue for fiscal year 2025, up 3.4% from the comparable figures in last year’s published list, with combined profits of US$150.0 billion. Concentration at the top remains pronounced: the top five companies account for US$514.1 billion in revenue (27.4% of the total); the top 20 account for US$850.4 billion (45.3%).

“What this year’s Southeast Asia 500 really tells us is that the region is starting to decouple from its commodity identity. The corporate center of gravity is moving toward finance, technology, and a new tier of national champions,” notes Andrew Staples, Editorial Director, Asia. “The fourth edition, in 2027, will tell us whether 2026 marked the start of a genuine reordering of the Southeast Asian corporate landscape — or simply a particularly good year for the region’s emerging tier,” he adds.

Thirty-four new companies joined the ranking, including two Singapore-headquartered bitcoin miners making their first appearance on the list. Bitdeer Technologies Group (No. 401) with US$620.3 million in revenue, and BitFuFu (No. 475) with US$477.5 million, are the first crypto-mining companies ever to qualify for the Fortune Southeast Asia 500, a sign that the region’s corporate landscape is broadening into new categories even as the bar to compete rises sharply.

Among movers, Yanlord Land fell 98 places as revenue dropped 60.5%, and Lopez Holdings fell 94 places on a 49.5% revenue decline. On the upside, both standout risers came from Indonesia: Hartadinata Abadi climbed 115 places on revenue growth of 135%, while Barito Pacific rose 102 places on growth of 220%.

Among the 500 companies, 40 are led by female CEOs — including Tan Su Shan of DBS (No. 8), who ranks sixth globally and first in Asia on Fortune’s 2026 Most Powerful Women in Business list.

In his introduction to the new list in the June/July issue of Fortune Asia magazine, editor, Asia, Nick Gordon notes, the Fortune Southeast Asia 500 captures “Southeast Asia shrugged off tariffs and trade protectionism last year to remain one of the world’s most dynamic regions. Southeast Asian countries are vital nodes in global supply chains; foreign investment from both Asia and the West is pouring in; and the region’s young, mobile-savvy consumers are driving domestic spending.”

The 2026 Fortune Southeast Asia 500 list and stories are available internationally on Fortune.com/asia and on newsstands across Asia starting today, June 16. The list and rankings can be viewed at https://fortune.com/asia/ranking/southeast-asia-500/2026/.

About Fortune

Fortune is the premier global media company for global business leaders, built on a 96-year-old legacy of trusted, award-winning journalism. Independently owned, Fortune tells the story of business, spanning legacy companies to the world’s new generation of innovators. Fortune measures corporate performance through rigorous benchmarks, and holds companies accountable, in regions around the world. Its iconic rankings include Fortune 500, Fortune Global 500, Most Powerful Women, and World’s Most Admired Companies. Fortune builds world-class communities by convening industry thought leaders for exclusive summits and conferences, including the Fortune Global Forum, Fortune Brainstorm Tech, and Fortune Most Powerful Women. For more information, visit fortune.com.

Media Contacts:

Patrick Reilly
Fortune 
Patrick.Reilly@fortune.com

Charmian Choo
Fortune in Asia
Charmian.CHOO@fortune.com

Chelsea Hudson
Fortune
Chelsea.Hudson@fortune.com

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SOURCE Fortune Media (USA) Corporation

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