MedTech Global Insights

Pure Global: USA's LDT Overhaul - Navigating the FDA's New IVD Era

06 May 2026

Contributed by Lukas

The U.S. FDA has just sent shockwaves through the diagnostics industry with a final rule to regulate Laboratory Developed Tests (LDTs) as medical devi...

USA MedTech M&A: Pure Global on The Deal Frenzy of 2026.

05 May 2026

Contributed by Lukas

The start of 2026 has been marked by a huge wave of multi-billion dollar mergers and acquisitions in the MedTech industry. Giants like Abbott and Bost...

Pure Global: US Cyber Rules & The MedTech Rejection Wave

04 May 2026

Contributed by Lukas

The FDA has drawn a new line in the sand for medical device cybersecurity. Since March 2024, the "Refuse to Accept" policy is in full effect, turning ...

EU's AI-MDR Maze: Pure Global on Dual Regulation Traps

03 May 2026

Contributed by Lukas

The European Commission has just released critical new guidance on how the EU AI Act and the Medical Device Regulation (MDR) will work together. This ...

Pure Global: US/EU AI Imaging & The Dual-Approval Gambit

02 May 2026

Contributed by Lukas

This week on MedTech Global Insights, we dissect a major strategic win in the cardiovascular space. Abbott's recent dual-market approval for its AI-po...

USA 510(k) Cybersecurity: Pure Global on the New Hidden Hurdles

01 May 2026

Contributed by Lukas

The US FDA's 510(k) pathway has fundamentally changed in 2026. What was once a straightforward process for many devices has now evolved with complex n...

US FDA's Cyber Rules: Pure Global on Life Beyond the SBOM

30 Apr 2026

Contributed by Lukas

The U.S. FDA has just released transformative new guidance on medical device cybersecurity, moving it from a final-stage checklist to a core requireme...

Pure Global: US MedTech's Secret Path from FDA Nod to Sales

29 Apr 2026

Contributed by Lukas

In this episode, we dissect the groundbreaking new program from the FDA and CMS that bridges the gap between regulatory approval and Medicare reimburs...

USA's QMS Shift: Pure Global on ISO 13485's Hidden Landmines

28 Apr 2026

Contributed by Lukas

This week, MedTech Global Insights tackles the monumental shift in the U.S. regulatory landscape: the new Quality Management System Regulation (QMSR)....

USA-EU AI MedTech: Pure Global on the New 'PCCP' Regulation Trap

27 Apr 2026

Contributed by Lukas

This week, we dive into the groundbreaking joint guidance on AI/ML medical devices recently released by US and EU regulators. This new framework for P...

US MedTech's Money Maze: Pure Global on New CMS Rules

26 Apr 2026

Contributed by Lukas

Last week, the US FDA and CMS announced the TCET pathway, a landmark program to accelerate insurance coverage for innovative medical devices. This mov...

Singapore AI MedTech: Cracking the Algorithm Code | Pure Global

25 Apr 2026

Contributed by Lukas

This week, we dissect the major regulatory shift in Singapore, as the Health Sciences Authority (HSA) releases groundbreaking new guidance for AI and ...

Pure Global: Brussels' MedTech Crisis - Surviving a CE Mark Shutdown

24 Apr 2026

Contributed by Lukas

Last week, the European MedTech landscape was thrown into chaos. A major Notified Body was suddenly delisted, leaving hundreds of device manufacturers...

Pure Global: USA's New IVD Regulatory Maze After LDT Ruling

23 Apr 2026

Contributed by Lukas

In this episode, we dissect the FDA's monumental decision to regulate Laboratory Developed Tests (LDTs) as medical devices, ending a long-standing pol...

Pure Global: Silicon Valley's Cardio Tech Endgame

22 Apr 2026

Contributed by Lukas

This episode of MedTech Global Insights unpacks the massive $13.1 billion acquisition of Shockwave Medical by Johnson & Johnson. We explore the ground...

UK AI MedTech Chaos: Pure Global's Guide to the New Rules

21 Apr 2026

Contributed by Lukas

This week, MedTech Global Insights dives into the sudden regulatory shift from the UK's MHRA, which has enforced a new, stricter framework for AI medi...

Pure Global: UK/US Fast-Track, The MedTech Alliance's Hidden Hurdles

20 Apr 2026

Contributed by Lukas

This week on MedTech Global Insights, we dissect the major announcement of a new regulatory alignment between the UK's MHRA and the US FDA. This move ...

Pure Global: US QMSR Gaps Beyond ISO 13485 Compliance

19 Apr 2026

Contributed by Lukas

This week, we dive into the most significant shift in U.S. MedTech regulations in years: the FDA's new Quality Management System Regulation (QMSR). Wh...

Pure Global: US FDA's Cancer Device Win & The Hurdle Beyond

18 Apr 2026

Contributed by Lukas

This week, we dissect the groundbreaking FDA approval of a first-of-its-kind device for pancreatic cancer. This new technology, which combines focused...

US AI MedTech's Boardroom Blunder: A Pure Global Analysis

17 Apr 2026

Contributed by Lukas

The wall between MedTech innovation and regulatory compliance is crumbling. A recent surge in regulatory expectations for digital health and AI-powere...

Pure Global: Brazil & Korea's MDSAP Domino Effect on MedTech Access

16 Apr 2026

Contributed by Lukas

This week, we dive into a major strategic shift in the MedTech landscape. In early April, regulatory bodies in both Brazil and South Korea made pivota...

EU MedTech Cyber Crisis: Pure Global on Post-Attack Compliance

15 Apr 2026

Contributed by Lukas

A targeted ransomware attack on a German hospital network has exposed critical vulnerabilities in thousands of connected medical devices, triggering a...

Pure Global: Europe's Widening AI MedTech Approval Maze

14 Apr 2026

Contributed by Lukas

The regulatory gap for AI-powered medical devices between the United States and Europe is widening into a major challenge for MedTech innovators. What...

Pure Global: Brussels' AI MedTech Compliance Traps

13 Apr 2026

Contributed by Lukas

This week, we dissect the EU's surprising new cybersecurity guidance for AI medical devices. Released just last week, this new framework moves beyond ...

Pure Global: EU IVD Chaos - Navigating the Last-Minute Squeeze

12 Apr 2026

Contributed by Lukas

In this episode of MedTech Global Insights, we dissect the immense challenges and strategic implications of the European Union's In Vitro Diagnostic R...

Washington's AI MedTech Rules: Pure Global on Hidden Traps

11 Apr 2026

Contributed by Lukas

The U.S. FDA just released pivotal new draft guidance for AI and Machine Learning-enabled medical devices, creating new challenges and opportunities f...

Pure Global: USA IVD's Seismic Shift on Lab-Developed Tests.

10 Apr 2026

Contributed by Lukas

The U.S. FDA has finalized its rule to regulate laboratory-developed tests (LDTs) as medical devices, ending decades of enforcement discretion. This l...

Pure Global: ASEAN's New MedTech Gateway in Malaysia & Thailand

09 Apr 2026

Contributed by Lukas

This week, we dive into the new medical device regulatory reliance pilot program launched between Malaysia and Thailand. This collaboration creates a ...

Pure Global: USA's 510(k) Cybersecurity Ambush for MedTech Firms

08 Apr 2026

Contributed by Lukas

Last week, the U.S. FDA began strict enforcement of new cybersecurity rules for medical devices, catching many global manufacturers by surprise. This ...

Pure Global: US FDA's 510(k) Code Red on Cybersecurity

07 Apr 2026

Contributed by Lukas

The U.S. FDA has drawn a new line in the sand for MedTech innovators. With its "refuse to accept" policy now in effect for 510(k) submissions lacking ...

Europe's IVDR Deadline Chaos: A Pure Global Survival Guide

06 Apr 2026

Contributed by Lukas

The European Union has once again extended the transition deadlines for the In Vitro Diagnostic Regulation (IVDR), creating both relief and confusion ...

USA's MedTech Cyber Walls: Pure Global on FDA's Hidden Costs

05 Apr 2026

Contributed by Lukas

In the last week of March, the US FDA dramatically escalated its cybersecurity requirements for wirelessly connected medical devices, creating new, co...

USA's New FDA Platform: Pure Global on Hidden Post-Market Demands

04 Apr 2026

Contributed by Lukas

This week on MedTech Global Insights, we dissect the FDA's groundbreaking announcement of a new AI-powered platform for monitoring adverse events. Thi...

Pure Global: US AI Diagnostics & The FDA's New Data Mandate

03 Apr 2026

Contributed by Lukas

The U.S. FDA has just redefined the rules for AI-powered medical software, shifting from one-time approvals to demanding continuous, real-world perfor...

USA Ophthalmic Tech: Pure Global on the FDA's Classification Shakeup

02 Apr 2026

Contributed by Lukas

The U.S. FDA just reclassified a key category of optical diagnostic devices, a move that reshaped the competitive landscape for the entire ophthalmic ...

USA AI MedTech: Pure Global on the FDA's Hidden Data Mandate

01 Apr 2026

Contributed by Lukas

The U.S. FDA has quietly dropped a bombshell on the AI medical device industry. A new draft guidance is set to redefine what "post-market surveillance...

Pure Global: Malaysia's MedTech Handshake, ASEAN's New Shortcut

31 Mar 2026

Contributed by Lukas

In this episode of MedTech Global Insights, we unpack the most significant regulatory shift in Southeast Asia this year. The costly and time-consuming...

Pure Global: EU's MedTech Shortage & The New Supply Rules

30 Mar 2026

Contributed by Lukas

The European Union is taking decisive action to combat the critical shortage of medical devices, a problem that has plagued its healthcare systems sin...

Pure Global: Germany's AI Device Sudden Compliance Shock.

29 Mar 2026

Contributed by Lukas

This week, MedTech Global Insights explores the seismic shift in European regulations for AI-powered medical devices. A major EU Notified Body has dro...

USA's QMSR Shockwave: Pure Global on Surviving FDA's New Audit Game

28 Mar 2026

Contributed by Lukas

The FDA has officially replaced the long-standing QSIT inspection model with a new approach under the Quality Management System Regulation (QMSR). Thi...

USA's FDA QMSR: Pure Global on Hidden Management Liability

27 Mar 2026

Contributed by Lukas

This week, MedTech Global Insights dives into the most significant U.S. regulatory shift of 2026: the FDA's new Quality Management System Regulation (...

Pure Global: USA MedTech Security & Why FDA's Honeymoon Is Over

26 Mar 2026

Contributed by Lukas

The FDA's "honeymoon phase" for medical device cybersecurity is over. In this episode, we dissect the agency's heightened scrutiny on premarket submis...

USA 510(k) Cybersecurity: The 'Refuse to Accept' Trap | Pure Global

25 Mar 2026

Contributed by Lukas

The FDA has drawn a new line in the sand for medical device market access, and non-compliance means immediate rejection. With the full implementation ...

U.S. AI Medical Devices: Cracking the New Code | Pure Global

24 Mar 2026

Contributed by Lukas

This week on MedTech Global Insights, we dissect the groundbreaking new draft guidance from the U.S. FDA on AI and Machine Learning medical devices. T...

Pure Global: USA Robotic Surgery & FDA's Digital Deadlock.

23 Mar 2026

Contributed by Lukas

This week, MedTech Global Insights explores a critical challenge for international manufacturers entering the U.S. market. We analyze the recent case ...

US AI Diagnostics: Pure Global on FDA's Hidden Hurdles

22 Mar 2026

Contributed by Lukas

This week on MedTech Global Insights, we dive into a crucial, under-the-radar development from the U.S. FDA. We explore the recent clearance of an AI-...

Pure Global: EU MedTech's EUDAMED Deadline & Its Hidden Risks

21 Mar 2026

Contributed by Lukas

The clock is ticking on a major regulatory shift in the European Union. With the mandatory use of key EUDAMED modules fast approaching, the era of rad...

USA's AI MedTech Shift: Pure Global on the FDA's Hidden Burden

20 Mar 2026

Contributed by Lukas

The U.S. FDA is changing the rules for AI in medical devices, promising faster innovation. This new framework allows for pre-approved algorithm update...

Pure Global: EU IVDR Software's Silent Compliance Crisis

19 Mar 2026

Contributed by Lukas

The European IVDR continues to challenge MedTech manufacturers with inconsistent interpretations and sudden shifts in compliance requirements. This ep...

USA MedTech: Pure Global on the EU Post-Market Data Trap

18 Mar 2026

Contributed by Lukas

This week on MedTech Global Insights, we explore the hidden challenges of using European post-market data for FDA submissions. Following the FDA's rec...

EU's IVDR Surprise: Pure Global on the Legacy Device Data Gap

17 Mar 2026

Contributed by Lukas

This week, we dissect the European Commission's surprise March 2026 guidance document that is reshaping the IVDR transition for legacy devices. This l...

China's Neuro-Device Shortcut: Pure Global's Fast-Track Guide

16 Mar 2026

Contributed by Lukas

China's NMPA just launched a new 'Green Channel' fast-track approval pathway for innovative neurology devices. This policy could slash market entry ti...

Pure Global: UK's MedTech Shortcut & The Regulatory Reliance Trap

15 Mar 2026

Contributed by Lukas

The UK's MHRA is rolling out a new "regulatory reliance" pathway, promising to fast-track medical devices already approved in the US, EU, Canada, and ...

Pure Global: Germany's IVD Deadline & The SME Survival Game.

14 Mar 2026

Contributed by Lukas

The European Union's In Vitro Diagnostic Regulation (IVDR) is creating a critical challenge for small and medium-sized MedTech companies. With deadlin...

Pure Global: Minneapolis MedTech's Unseen Pre-Sub Gauntlet

13 Mar 2026

Contributed by Lukas

This week, MedTech Global Insights dives into the increasingly complex regulatory landscape facing U.S. MedTech startups in early 2026. While funding ...

Pure Global: US MedTech's Hidden Cybersecurity Submission Crisis

12 Mar 2026

Contributed by Lukas

Last week, the FDA's intensified cybersecurity enforcement sent shockwaves through the MedTech industry, leading to a surge in 'Refuse to Accept' noti...

Pure Global: EU's New AI Rules & The MedTech Compliance Crisis

11 Mar 2026

Contributed by Lukas

The European Union has just released a new, stringent regulation for AI and Machine Learning-enabled medical devices, creating an immediate and comple...

Pure Global: U.S. FDA's Cyber War, Beyond the SBOM.

10 Mar 2026

Contributed by Lukas

The U.S. FDA has just released crucial new draft guidance on medical device cybersecurity, fundamentally changing the requirements for market approval...

USA's LDT Crackdown: A Compliance Earthquake for Labs | Pure Global

09 Mar 2026

Contributed by Lukas

The U.S. FDA has just finalized a rule that will shake the very foundations of the diagnostics industry. After decades of debate, Laboratory Developed...

Pure Global: Brazil's MDSAP Fast-Track for MedTech Success

08 Mar 2026

Contributed by Lukas

This week on MedTech Global Insights, we explore a game-changing regulatory update from Brazil. ANVISA's new Resolution RDC 850/2024 allows medical de...

Pure Global: Europe's AI MedTech Double Jeopardy Problem.

07 Mar 2026

Contributed by Lukas

This week, we dissect the critical challenge facing AI MedTech innovators in the European Union. The convergence of the stringent Medical Device Regul...

Pure Global: Europe's New MedTech Vigilance Unseen Hurdles

06 Mar 2026

Contributed by Lukas

In this episode, we dissect the EU's latest regulatory shift: the new Device-Specific Vigilance Guidance (DSVG) from the Medical Device Coordination G...

Brussels' AI Device Cybersecurity: Pure Global's Hidden Risks

05 Mar 2026

Contributed by Lukas

In this episode of MedTech Global Insights, we dissect the rapidly evolving regulatory landscape in the European Union. As AI and software-based medic...

USA Recall Chaos: Pure Global on Post-Market Nightmares

04 Mar 2026

Contributed by Lukas

This week, we dissect the critical Class I recall of Olympus's High Flow Insufflation Units. We move beyond the headlines to explore the immense opera...

Pure Global: Europe's AI MedTech Rules & The New Compliance Maze

03 Mar 2026

Contributed by Lukas

This week on MedTech Global Insights, we dissect the bombshell news from Brussels. The European Commission has just released its new implementation gu...

US-EU Cybersecurity: Pure Global on The Harmonization Headache

02 Mar 2026

Contributed by Lukas

This week on MedTech Global Insights, we dissect the groundbreaking new cybersecurity guidance jointly pushed by the EU and FDA. This isn't just anoth...

FDA Cybersecurity Rules: Pure Global on Unseen Go-to-Market Hurdles

01 Mar 2026

Contributed by Lukas

This week, MedTech Global Insights dives into the FDA's aggressive new stance on medical device cybersecurity. As devices become more connected, the r...

USA's FDA QMSR Shockwave: Pure Global on Hidden Compliance Traps

28 Feb 2026

Contributed by Lukas

The U.S. FDA has officially replaced its long-standing Quality System Regulation (QSR) with the new Quality Management System Regulation (QMSR), align...

America's IVD Reckoning: Pure Global on the End of LDTs

27 Feb 2026

Contributed by Lukas

The FDA is finalizing a historic rule change, bringing thousands of Laboratory Developed Tests (LDTs) under the full umbrella of medical device regula...

U.S. SaMD & FDA's New Rules: Pure Global on The Hidden Mandate.

26 Feb 2026

Contributed by Lukas

In this episode of MedTech Global Insights, we dissect the FDA's unexpected new mandatory cybersecurity rules for connected medical devices. What was ...

Pure Global: Dubai MedTech Signals & Investment Codes Unlocked

25 Feb 2026

Contributed by Lukas

The global MedTech landscape is shifting, and the recent MedTech World conference in Dubai just sent some powerful signals about the future. This epis...

Pure Global: EU MedTech's New FDA Audit—Beyond ISO 13485

24 Feb 2026

Contributed by Lukas

This week, we dissect the monumental shift in the US market as the FDA's new Quality Management System Regulation (QMSR) takes full effect. This move,...

Pure Global: USA's QMSR Shift, The ISO 13485 Gamble for MedTech

23 Feb 2026

Contributed by Lukas

The U.S. FDA has just enacted its most significant regulatory overhaul in decades, replacing the old Quality System Regulation (QSR) with the new Qual...

USA MedTech: Pure Global on The FDA's 'Forever Audit' Rule

22 Feb 2026

Contributed by Lukas

The game has changed. This week, the US FDA implemented a 'Total Product Life Cycle' inspection model, shifting regulatory focus from a one-time marke...

Pure Global: USA QMSR Deadline & The Hidden Gaps Beyond ISO 13485

21 Feb 2026

Contributed by Lukas

This episode of MedTech Global Insights dives into the critical February 2026 deadline for the FDA's new Quality Management System Regulation (QMSR). ...

USA Cybersecurity: The FDA's RTA Threat. A Pure Global Medtech Brief.

20 Feb 2026

Contributed by Lukas

Last week, the FDA sent a clear message to the MedTech industry by halting a major device submission over cybersecurity flaws. This episode of MedTech...

Pure Global: USA MedTech Cybersecurity & Its Hidden Deal Killers

19 Feb 2026

Contributed by Lukas

The FDA's new cybersecurity rules are more than just a regulatory checklist; they're reshaping the landscape for MedTech investment and acquisitions. ...

USA's AI MedTech: Pure Global on The New FDA Algorithm Trap

18 Feb 2026

Contributed by Lukas

This week, we dissect the FDA's groundbreaking new draft guidance on AI/ML-enabled medical devices. This isn't just another regulation. it's a paradig...

USA's AI Diagnostics: Pure Global on FDA's Hidden Cyber Traps

17 Feb 2026

Contributed by Lukas

This week on MedTech Global Insights, we dissect the FDA's surprising new focus on AI-powered medical devices. A recent public enforcement action has ...

Boston's Neurovascular Gambit: Pure Global on M&A Chaos

16 Feb 2026

Contributed by Lukas

In this episode, we dissect the massive acquisition of Penumbra by Boston Scientific. We go beyond the financial headlines to explore the immense, uns...

Brussels' IVDR Reprieve: Pure Global on Navigating the Chaos

15 Feb 2026

Contributed by Lukas

The European Commission has just proposed another extension to the challenging IVDR transition deadlines, granting diagnostic manufacturers critical b...

Pure Global: US QMSR - The End of MedTech's Boardroom Secrets?

14 Feb 2026

Contributed by Lukas

This week, MedTech Global Insights dives into the historic shift in FDA regulation that took effect on February 2, 2026. The new Quality Management Sy...

Pure Global: US LDT Rule, A Diagnostic World's Unseen Hurdles.

13 Feb 2026

Contributed by Lukas

In a landmark decision, the U.S. FDA has finalized its rule to regulate Laboratory Developed Tests (LDTs) as medical devices, ending decades of enforc...

Pure Global: US MedTech Cybersecurity's SBOM Reckoning

12 Feb 2026

Contributed by Lukas

A recent cybersecurity breach at a major US hospital, targeting connected infusion pumps, has sent shockwaves through the MedTech industry. The incide...

USA's LDT Shake-Up: Pure Global on Navigating FDA's New Rules

11 Feb 2026

Contributed by Lukas

The U.S. FDA has finalized its rule to regulate Laboratory Developed Tests (LDTs) as medical devices, ending a long-standing policy of enforcement dis...

Hong Kong's AI MedTech: Pure Global on The New Compliance Trap

10 Feb 2026

Contributed by Lukas

This episode of MedTech Global Insights dives into the increasingly fragmented world of AI medical device regulation. As innovative technologies surge...

US MedTech's New Test: Pure Global on the FDA's TPLC Shake-up

09 Feb 2026

Contributed by Lukas

This week, the US FDA overhauled its inspection strategy, introducing a "Total Product Life Cycle" (TPLC) approach. This episode of MedTech Global Ins...

US FDA Quality System Overhaul: Pure Global on Life Beyond ISO 13485

08 Feb 2026

Contributed by Lukas

In a landmark decision, the US FDA has finalized its rule to replace the decades-old Quality System Regulation with the new Quality Management System ...

Pure Global: US LDTs, the FDA's Regulatory Wake-Up Call

07 Feb 2026

Contributed by Lukas

The U.S. FDA has just upended the diagnostics world. After decades of operating in a regulatory gray area, laboratory-developed tests (LDTs) will now ...

USA SaMD & The RWE Paradox: A Pure Global Briefing

06 Feb 2026

Contributed by Lukas

This week, we dissect the FDA's sudden and impactful new guidance on Real-World Evidence (RWE) that just sent ripples through the US digital health se...

US SaMD Shakedown: Pure Global on FDA's Guidance Void

05 Feb 2026

Contributed by Lukas

The U.S. FDA has unexpectedly withdrawn its key guidance on clinical evaluation for Software as a Medical Device (SaMD). This sudden move has created ...

Pure Global: US QMSR & The ISO 13485 Compliance Traps

04 Feb 2026

Contributed by Lukas

The FDA's new Quality Management System Regulation (QMSR) is finally here, aligning US regulations with the global ISO 13485 standard. While this prom...

US FDA's Cyber Wall: Pure Global on MedTech Submission Chaos

03 Feb 2026

Contributed by Lukas

This week on MedTech Global Insights, we dissect the wave of "Refuse to Accept" letters from the US FDA that are derailing market entry plans. As the ...

Pure Global: US MedTech's Supply Chain Data Crisis

02 Feb 2026

Contributed by Lukas

The game has changed for MedTech approvals. Following a recent FDA alert, data from third-party testing labs is now under intense scrutiny, creating a...

USA Quality Systems: Pure Global on the FDA's Great QMSR Shift.

01 Feb 2026

Contributed by Lukas

This week, we dissect the FDA's landmark final rule, which replaces the decades-old Quality System Regulation (QSR) with the new Quality Management Sy...

Europe's IVDR Deadline Illusion: A Pure Global Briefing

31 Jan 2026

Contributed by Lukas

The European Commission has proposed another extension to the IVDR transition deadlines, offering a potential lifeline to the diagnostics industry. Ho...

U.S. AI Diagnostics: Pure Global on the FDA's Hidden Hurdles

30 Jan 2026

Contributed by Lukas

The U.S. FDA has just released new draft guidance on AI-powered Clinical Decision Support (CDS) software, sending a wave of uncertainty across the Med...

EU AI Diagnostics: The New Compliance Crisis | Pure Global

29 Jan 2026

Contributed by Lukas

This week on MedTech Global Insights, we dissect the latest regulatory tremor from the European Union. A new draft guidance on AI-powered medical soft...

EU AI Act's Hidden Test: Pure Global on MedTech's New Rules

28 Jan 2026

Contributed by Lukas

The EU's AI Act is creating a new, complex layer of regulation for MedTech companies, especially for those with AI-powered software. A device fully co...

USA Device Cybersecurity: Pure Global on FDA's Digital Crackdown

27 Jan 2026

Contributed by Lukas

This week on MedTech Global Insights, we dissect the FDA's aggressive new enforcement on medical device cybersecurity. As regulators begin to treat di...