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BDO Legal Guide To The New Artificial Intelligence Regulation (AI Act) – New Technology

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Forming part of BDO’s Global Network, BDO Malta is a professional services and advisory firm, assisting companies in accelerating business growth through exceptional client service. Established in 1978, BDO Malta provide a wide portfolio of services including regulatory advisory, outsourcing, audit and assurance, tax & technology regulatory compliance to assist clients across different industries in growing their businesses efficiently.



Regulation (EU) 2024/1689, establishing rules on artificial intelligence (hereinafter referred to as the “Regulation” or “AI Act”), represents a milestone in the regulation of emerging technologies.


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Regulation (EU) 2024/1689, establishing rules on artificial
intelligence (hereinafter referred to as the
Regulation” or “AI
Act
”), represents a milestone in the regulation of
emerging technologies. It ensures that  Artificial Intelligence (hereinafter,
“AI”) is developed and used in a safe and
ethical manner within the European Union
, while
simultaneously supporting technological innovation without imposing
unnecessary restrictions.

Who does it apply to? The AI Act applies to all
organisations within the European Union, as well as foreign
entities that intend to use, develop, or market AI products in the
EU market.

Only certain areas are excluded, such as military, defence,
national security, scientific research, and purely personal
activities, among others.

What is meant by Artificial Intelligence? An AI system
is defined as any machine-based system that operates autonomously
and learns from its environment.

Any company may assume one of the following two
main roles
 in relation to an AI system:

  • Developer/Provider of the system: the
    company or individual who develops and offers the AI system.

  • Deployer: the entity that uses or
    implements an AI system within its organisation.

What obligations does the AI Act impose? The AI
Act classifies AI systems according to their risk
level. Systems deemed high-risk must comply with stricter
requirements to ensure safety and reliability, whereas low-risk
systems are subject to more flexible obligations.

It also introduces a list of prohibited practices which will be
banned within the European Union six months after the Regulation
enters into force.

Obligations vary depending on the company’s role regarding
the AI system (provider or deployer), and
include: notifying and registering AI
systems
conducting conformity
assessments
drafting and approving internal
use policies
informing users about the AI
system
ensuring product and 
creating supervisory authorities and regulatory
sandboxes
, among others.

Want to know more? To support understanding, we are pleased to
present the “BDO Legal Guide to the New
Artificial Intelligence Regulation (AI Act) and Its Impact on
Companies
”, which outlines the range of services
through which  BDO Legal can assist companies in
efficiently adapting to this regulation.

DOWNLOAD THE GUIDE

The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.



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How AI will change the CIO role

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What you signed up for five years ago is not what the business expects of you today,” Jonathan Rickard told the NZ CIO Summit in Auckland.

Rickard, chief technology officer Microsoft CX at Fusion5, says AI has pushed CIOs from back-office tech management into front-line strategic leadership. Their job is no longer about implementation alone but about steering digital transformation across the business.

Today’s CIOs are now more involved in business areas such as innovation and revenue-generating initiatives. He says: “It’s no longer a matter of just keeping the lights on.”

CIO is an evolving role

More change is on the way with the CIO role becoming a people-focused, innovation-driven position. There is a strong emphasis on culture and measurable business outcomes.

Rickard quoted research to support this view. Following this year’s Sydney CIO Summit, attendees were asked about their roles. Nearly half, 47 percent, say they focus on innovation and strategy. That’s double the number (23 percent) who said the same five years ago.

The survey shows a majority of CIOs (85 percent) are involved in new revenue opportunities and a similar number (84 percent) say they have greater influence on business decisions.

For Rickard, AI is a general-purpose technology that changes everything. He says some skepticism is understandable; only recently CIOs were told they would be leading their businesses into the metaverse by now.

Instead, he compares AI with the steam engine, the internet, and smartphones. Each of these began with hype, which led to a negative reaction before the technologies were accepted and broadly adopted.

Real gains from intensity of use

What made the difference in each case was the intensity of use. Companies that merely swapped out old tools for new ones saw modest gains. Those that embedded the technology deeply into their processes and business models reaped outsized rewards. Rickard says the same will apply to AI: the real benefits will go to organisations that use it imaginatively and pervasively, not just at the margins.

Troy Gerber, CTO conversational AI and Copilot at Fusion5, says: “In the next two years, 30 percent of our workforce will be digital agents. They’re not going to be replacing people. They’ll be working alongside people.”

Gerber says CIOs will be responsible for integrating these digital agents into the workforce and ensuring they work alongside human employees.

Pressure as expectations increase

This will bring pressure as businesses will expect their AI investments to increase productivity. “The target is to gain two hours per employee every week. It will fall on CIOs to ensure the AI tools are not just implemented, but that they realise the expected gains”.

In addition to dealing with digital employees, he says CIOs will also be asked to help build the talented culture within organisations that is ready and able to leverage the AI technologies as they are rolled out. The responsibility that once resided in an HR department will shift to the CIO.

CIOs are widely expected to take ownership of innovation within a business. Gerber says the way this works will change.

In the past, CIOs rolled out tools and applied guardrails in an orderly process. Now, innovation bubbles up from staff. In many cases, they might adopt consumer-style AI tools (such as ChatGPT) first before looking for support.

Responsive to employee demands

Gerber says the CIO role here will be to respond to demand from employees and shape secure, scalable platforms around it.

This happened in the past with mobile phones. At first, they were telco or phone manufacturer-controlled. Then the smartphone arrived, and we shifted to the app-store-driven model. AI is going through the same change.

These changes are not abstract. Gerber says Fusion5 is going through the process in its own business. “We think of ourselves as a frontier firm: We live that every day, and we take it to our customers.

“Everyone in our organisation has to be AI literate. It’s mandatory. Staff have to go to our monthly AI training. We had a staff meeting last week where we showed a slide featuring our new joiners, and then we had a slide showing the new AI agents that had joined our organisation.”

He says there were eight of them, and they were featured because they are integral to the business. “We don’t bolt AI onto our solutions; it is part of our strategy.”

By showing staff the newcomers, they are able to see where they can be used in the company’s workflow.

Leading teams that mix humans and AI agents requires new leadership styles. That means listening, asking questions, and encouraging participation, not traditional command-and-control.

Gerber likes to quote Nvidia CEO Jensen Huang, who says success comes from strategic vision with executional discipline. “Success in the AI era belongs to those who can match strategic vision with executional discipline.”



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BioLab Holdings, Inc. Announces Strategic Investment in AI Diagnostic Technology

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Transatlantic Partnership Accelerates Wound Care Innovation

PHOENIX, Sept. 4, 2025 /PRNewswire/ — BioLab Holdings, Inc., a Phoenix-based medical manufacturer specializing in wound care products, is proud to announce its strategic investment and commercialization partnership with cureVision, a breakthrough digital wound care company using optical sensors, 3D imaging and artificial intelligence, to revolutionize wound analysis and diagnosis.

cureVision, a Germany-based health tech startup, empowers clinicians to conduct fast, contact-free wound assessments, delivering comprehensive insights in less than two minutes. Certified under the European Medical Device Regulation (MDR), the intuitive system streamlines measurement, analysis, and documentation—helping healthcare professionals to track healing progress while reducing manual workload. With its expertise in advanced optical imaging solutions, the company follows its vision to provide a single source of truth for wound assessment while ensuring data integrity to support seamless collaboration and integration across care teams.           

“This partnership with cureVision reflects our commitment to advancing clinically differentiated technologies that fit into our larger goal for a more comprehensive and effective continuum of care,” said BioLab President Jaime Leija. “We’re excited to support cureVision’s entry into the U.S. market and help bring this transformative solution to providers and patients nationwide.”

Both partners anticipate that introducing cureVision to American healthcare will have a meaningful impact on patients and providers alike: “cureVision is putting advanced technologies to work so providers can focus on what matters most: the patient. We are excited to showcase our technology via BioLab’s outstanding network and presence in the U.S.” said Richard Fobo, CEO of cureVision. 

“We see immense potential in cureVision’s AI-driven technologies to transform wound care workflows,” said BioLab Chief Science Officer Dr. Carlos Encinas. “By combining their advanced imaging capabilities with our clinical expertise and distribution network, we’re accelerating a smarter, more efficient future for wound management.”

BioLab’s investment will support cureVision’s regulatory pathway and reimbursement strategy in the U.S., while also providing commercialization support through BioLab’s national distribution network.

“cureVision’s technology represents a leap forward in wound care diagnostics,” said BioLab Chief Medical Officer Dr. Marshall Medley. “By enabling a fast point-of-care-assessment, it empowers clinicians to provide more accurate wound documentation and improve treatment decision-making. We’re proud to support a solution that aligns so closely with our mission to improve patient outcomes.”

As part of the partnership, cureVision will gain access to the U.S.’s voice of the customer insights from distributors, providers, and patients, as well as guidance from BioLab’s medical advisory group led by Dr. Marshall Medley. Under the tagline “Two Missions, One Vision,” the companies aim to deliver comprehensive wound care that benefits patients, providers, and payers alike.

About BioLab Holdings, Inc.
BioLab Holdings, Inc. is a Phoenix-based medical manufacturer specializing in wound healing. Its products—including Membrane Wrap – Lite™, Tri-Membrane Wrap™, Membrane Wrap™, and Membrane Wrap – Hydro™—use human tissue allograft derived from amniotic membrane to provide structural tissue for wound protection. BioLab’s mission is to manufacture reliable and safe products with the highest quality to help optimize body performance through continuous innovation, education, superior customer service, and teamwork.

About cureVision
cureVision GmbH is a Germany-based health tech startup dedicated to improving wound care through artificial intelligence and advanced sensor technology. The company is supported by the Luminate program in Rochester, NY—an accelerator for world-class optics and photonics startups—and is an alumnus of the German Accelerator US Market Access program. cureVision’s solutions are certified medical devices in Europe and are available in several European countries.

Contact: Kwyn Lowe
Phone: 406.314.5120
Email: [email protected] 

Photo – https://mma.prnewswire.com/media/2764343/BioLab_and_cureVision.jpg
Logo – https://mma.prnewswire.com/media/2764342/BioLab_Holdings_Logo.jpg



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A High-Growth Play on AI-Driven Connectivity

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In the race to power the AI revolution, Credo Technology (CRDO) has emerged as a standout contender, leveraging its leadership in active electrical cables (AECs) and optical interconnects to capitalize on the explosive demand for high-speed, low-latency connectivity. With FY2026 shaping up as a pivotal year, investors are scrutinizing whether CRDO can sustain its hypergrowth trajectory amid intensifying competition and macroeconomic headwinds.

Financials: A Story of Explosive Growth

Credo’s Q1 2026 results, reported on August 2, 2025, underscore its meteoric rise. Revenue surged to $223.1 million, a 274% year-over-year increase and 31% sequential growth, far outpacing the $190.63 million Wall Street consensus [1]. Adjusted earnings per share (EPS) of $0.52 crushed estimates of $0.35, while non-GAAP net income ballooned to $98.3 million from $7 million in the prior-year period [1]. The company’s gross margin of 67.6% reflects operational discipline, and its cash reserves of $479.6 million provide a buffer for R&D and strategic expansion [2].

Looking ahead, CRDO’s Q2 2026 guidance of $230–240 million revenue—well above the $199 million analyst consensus—signals confidence in maintaining momentum [1]. This performance positions Credo as one of the fastest-growing semiconductor plays in the AI infrastructure space.

Strategic Positioning: AEC and Optical Markets as Growth Engines

Credo’s dominance in AECs is a cornerstone of its strategy. These cables, which offer 100x greater reliability than laser-based optical solutions and superior signal integrity over direct-attach copper (DACs), are becoming indispensable in AI data centers [3]. The company’s system-level approach—owning SerDes IP, retimer ICs, and production—enables rapid innovation cycles and cost efficiency. For instance, its PCIe Gen6 AECs for scale-up AI networks have driven triple-digit sequential growth in Q4 2025 [3].

The optical market is another growth catalyst. Credo’s recent 800G transceiver design win and development of ultra-low-power 100G-per-lane DSPs position it to double optical revenue in FY2026 [4]. Management’s focus on 3-nanometer 200G-per-lane DSPs further underscores its commitment to setting industry standards for power efficiency [4].

Customer Diversification and IP Strength

While Credo’s Q3 2025 revenue was heavily skewed toward Microsoft (86% of total), the company is actively diversifying its customer base. Three hyperscalers now contribute >10% of quarterly revenue, and two additional clients are in qualification [5]. This shift mitigates concentration risk while aligning with the broader trend of hyperscalers investing in AI infrastructure.

Credo’s intellectual property (IP) moat is equally formidable. Its proprietary SerDes technology and end-to-end control of the connectivity stack create barriers to entry. As CEO Bill Brennan noted in the Q1 2026 earnings call, “Our IP leadership allows us to define the next generation of interconnect standards” [6]. This advantage is critical in markets where differentiation hinges on power efficiency and reliability.

Market Tailwinds: AI Infrastructure as a Multi-Trillion-Dollar Opportunity

The AI data center market is projected to grow at a 31.6% CAGR, expanding from $236.44 billion in 2025 to $933.76 billion by 2030 [7]. Credo’s AEC and optical solutions are directly aligned with this demand, particularly in scale-up AI clusters requiring high-capacity, low-latency interconnects. Meanwhile, the optical interconnect market is forecasted to grow at 12.6–13.5% CAGR, reaching $35.3–49 billion by 2030 [8].

Risks and Competitive Dynamics

Despite its strengths, Credo faces challenges. Its 0.63% market share in semiconductors pales against giants like Broadcom (82.71%) and Marvell (9.05%), though its niche focus on AI infrastructure offers a path to outperformance [9]. Macro risks include potential softening in AI spending and supply chain bottlenecks. However, Credo’s diversified customer pipeline and R&D investments in PCIe retimers and 400G ports provide growth levers [5].

Conclusion: A High-Conviction Bet on Next-Gen Infrastructure

Credo Technology’s combination of record-breaking financials, proprietary IP, and strategic alignment with AI-driven connectivity trends makes it a compelling high-growth play. While risks such as customer concentration and competitive pressures persist, the company’s innovation pipeline and market positioning suggest it is well-equipped to sustain hypergrowth in FY2026 and beyond. For investors seeking exposure to the AI infrastructure boom, CRDO represents a rare blend of scalability and technical differentiation.

Source:
[1] Credo Technology shares soar as Q1 earnings crush expectations [https://finance.yahoo.com/news/credo-technology-shares-soar-q1-211527224.html]
[2] Credo Technology Group (CRDO) AI Growth and Revenue Projections [https://www.monexa.ai/blog/credo-technology-group-crdo-surges-with-ai-data-ce-CRDO-2025-07-28]
[3] Credo Bets Big on AEC Business: Will It Deliver Sustainable Growth? [https://finance.yahoo.com/news/credo-bets-big-aec-business-141500129.html]
[4] Contradictions Emerge on Optical DSP Market, AECs, and Customer Concentration [https://www.ainvest.com/news/credo-q1-2026-earnings-call-contradictions-emerge-optical-dsp-market-aecs-customer-concentration-supply-chain-constraints-2509/]
[5] Credo Technology (CRDO): AI Growth, Risks, and Market Opportunities [https://www.monexa.ai/blog/credo-technology-crdo-ai-growth-risks-and-market-o-CRDO-2025-03-06]
[6] Credo Technology Q1 2026 Earnings Call Transcript [https://www.fool.com/earnings/call-transcripts/2025/09/03/credo-crdo-q1-2026-earnings-call-transcript/]
[7] AI Data Center Global Research Report 2025–2030 [https://finance.yahoo.com/news/ai-data-center-global-research-091100406.html]
[8] Optical Interconnect Market Size, Outlook 2025–2030 [https://www.mordorintelligence.com/industry-reports/optical-interconnect-market]
[9] CRDO’s Market Share Relative to Competitors [https://csimarket.com/stocks/competitionSEG2.php?code=CRDO]



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