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Medical Device Intelligence

Kardium pulse field ablation
September 5, 2025
Kardium pulse field ablation

Globe® Pulsed Field System receives FDA approval

The Globe System, according to the company, achieves highly durable lesions and an excellent safety profile, together with integrated high-density mapping and true single-shot PVI for treatment of atrial fibrillation.

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Viewpoints on MedTech
September 2, 2025
Viewpoints on MedTech

How AI health diagnostics could save lives – or create new risks

By Ivor Campbell

The rise of AI-powered health apps that claim to diagnose conditions in real time is transforming how we approach healthcare. From symptom checkers to wearable ECG monitors and AI stethoscope apps, these tools promise early diagnoses and personalized healthcare at our fingertips. What if they go wrong?

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combination devices
September 2, 2025
combination devices

Impact of Combination Products on the Medical Devices Industry

By Partha Anbil

A comprehensive update on the combination products market shows significant industry partnerships, development challenges, and strategic imperatives for success in the sector characterized by dynamic collaboration between pharmaceutical and device companies, rapid product development cycles, and complex regulatory landscapes.

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medtech design standards
August 28, 2025
medtech design standards

Significance of Harmonized standards

By Rajani Kumar Sindavalam

The importance of harmonized standards and how they will help the medical device manufacturers in developing devices that are safer and effective.

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Recor Paradise
August 28, 2025
Recor Paradise

First Medical Device Approved in Japan for the Treatment of Hypertension

Recor Medical Announces Paradise Ultrasound Renal Denervation System Receives Manufacturing and Marketing Approval in Japan for the Treatment of Resistant Hypertension.

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Terumo logo
August 28, 2025
Terumo logo

Terumo to acquire OrganOx, maker of organ preservation devices, marking strategic entry into organ transplantation market

Terumo Corporation is acquiring OrganOx Limited to enhance organ preservation technology and address transplant challenges globally. Acquisition marks Terumo entry into transplant sector.

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Airiver Medical Balloon
August 27, 2025
Airiver Medical Balloon

Airiver Medical Receives IDE Approval for Pulmonary Drug Coated Balloon Study

The nationwide study will assess the safety and efficacy of the technology that combines standard balloon dilation to open the respiratory tract with drug delivery designed to maintain symptom relief.

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Peytant Solutions Inc, AMStent Pulmonary Obstruction System
August 27, 2025
Peytant Solutions Inc, AMStent Pulmonary Obstruction System

Positive Pre-Clinical Results for AMStent Pulmonary Obstruction System

The AMStent System leverages a decellularized human amniotic membrane (DCAM). New pre-clinical outcomes demonstrating superior results compared to a commercially available synthetic polymer-covered stent were presented at the 2025 American Association for Bronchology and Interventional Pulmonology (AABIP) Annual Meeting.

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combination products
August 26, 2025
combination products

Drug-Led vs. Device-Led Combination Products: Determining the Primary Mode of Action (PMOA)

By Celegence

Understanding the nuances is crucial in determining the regulatory submission pathway, data requirements, and even post-approval compliance expectations.

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August 25, 2025

Zimmer / Stryker intensify rivalry in $400 million US knee reconstruction market

While Zimmer has been able to maintain the largest market share over the past decade, competition in the knee reconstruction space is no longer limited to pricing or incremental design improvements. It is evolving into a battle of technological sophistication and long-term clinical outcomes.

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Columns

February 3, 2026

AI in Medical Devices: Safety Questions the Industry Can’t Afford to Ignore

By Pujitha Gourabathini
Safety of AI in Medical Devices

Artificial intelligence is moving quickly into mainstream medical devices, and the industry has become fluent in a familiar set of concerns: bias, transparency, and cybersecurity. These topics matter, but they don’t capture the risks most likely to shape patient safety in the coming decade. The deeper challenges lie in the interactions between algorithms, clinical workflows, data pipelines, and human decision making. Those interactions are where safety is won or lost, and they remain the least examined part of AI adoption.

January 20, 2026

The Risk of Using a Device Off-Label Versus Contraindicated

By Attly Aycock
Off-label and contraindicated medical device use

While off-label use may be permissible, contraindicated use still has a strong regulatory boundary as reinforced by FDA guidance finalized in 2025.

January 20, 2026

The FDA Raised the Bar on MedTech Cybersecurity: Are Companies Ready?

By Justin Kozak
Balancing Cyber Risk

In the current Cyber Threat environment, companies must have strong cyber liability insurance. Policies must specifically account for cyber-physical risks and the substantial costs of post-market remediation, including mandatory software patches and patient notifications. Insurers are well aware of the 524B mandate and are increasingly requiring proof of compliance before issuing coverage or offering favorable rates. How do you assure your cyber risk plan insurable?

January 15, 2026

Contract Manufacturer, Domico Med-Device, opens 23,000 sq ft Facility in Mexico

By Randy Knotts
Domico Med-Device in Mexico

omico’s new facility expands its global production capacity and enhances its ability to be close to customers without taking on excessive risk.

January 6, 2026

R&D Operations Bottlenecks in Large Life Sciences Organizations: What can MedTech Leaders Do?

By Venkatesan (Venkat) Muthukrishnan
Medical Device R&D Bottleneck

How is software-enablement — connected devices and artificial intelligence — reshaping how products are conceived, developed, and deployed in clinical practice? Fragmented operations in large MedTech organizations are not keeping pace with the complexity of products in their pipelines.

January 6, 2026

How is AI Enabling Darwinian growth for Life Science Professionals?

By Ivor Campbell
Superemployees - AI human evolution

The initial fear that the artificial intelligence and machine learning evolution will replace humans is shifting. A new narrative recognizes the potential for an AI-enabled workforce — one where the technology is a jobs creator, enabling us all to be more productive rather than making millions of people redundant or obsolete — actually giving rise to the multi-disciplinary, power employee.

December 8, 2025

FDA Launches Technology-Enabled Meaningful Patient Outcomes (TEMPO) Pilot for Chronic Disease Technologies

By Randy Knotts
FDA Logo

The FDA announced the TEMPO pilot, an approach to encourage the use of digital technologies that meet people where they are. The pilot supports innovative tools and a health care delivery model that could improve care for millions of Americans managing chronic disease.

December 4, 2025

Using AI and LLMs to fill in fragmented data gaps within complex critical care

By Dimitar Baronov, PhD
Smart Critical Care

AI and large language models (LLMs) are revolutionizing critical care by integrating scattered data from various sources to deliver real-time insights. This allows for prompt escalation or de-escalation of treatment and enhances patient outcomes. These technologies also help reduce staffing issues and prevent clinician burnout by continuously monitoring patient risk and supporting decision-making in busy ICU settings.

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