MedTech Intelligence

What is driving the need for increased transparency across the MedTech organization relative to product innovation, development and commercialization?

The post Why Digital Tool are Needed to Cope with Increasing Pressures in MedTech Innovation appeared first on MedTech Intelligence.

Biotronik has received U.S. Food and Drug Administration (FDA) approval for its Solia CSP S pacing lead, growing access to a solution for Left Bundle Branch Area Pacing (LBBAP).

The post FDA Approval for BIOTRONIK Solia CSP S Pacing Lead For LBBAP appeared first on MedTech Intelligence.

New patient-specific solution expands Catalyst’s portfolio, enabling precise translation of 3D surgical plans into the operating room to reduce steps and increase accuracy .

The post Catalyst OrthoScience gets FDA 510(k) Clearance of Archer® Patient-Specific Instrumentation for Shoulder Arthroplasty appeared first on MedTech Intelligence.

Trauma and Extremities partnership aligns disciplined approach to portfolio optimization and focuses on delivering long-term value for surgeons and patients 

The post Smith+Nephew signs distribution agreement with SI-BONE appeared first on MedTech Intelligence.

Quantum Surgical and NeuWave Medical, Inc. – both of which share an extensive focus on innovation to improve cancer patients’ outcomes – will operate as subsidiaries of Precision IO Group Inc., the newly created parent company led by medtech veteran Kurt Azarbarzin, who was recently appointed CEO.

The post Quantum Surgical Acquires NeuWave Medical, Inc. appeared first on MedTech Intelligence.

Synchfix EVT features an all-in-one system that integrates suture tensioning handles within the implant instrumentation, along with a handle design for one-handed surgical implant deployment.

The post Stryker launches Synchfix™ EVT, expanding options for flexible syndesmotic fixation appeared first on MedTech Intelligence.

Commercialization strategy in 2026 and beyond is more than a checklist. It requires a new mindset where cybersecurity is seen as a patient safety imperative, data is treated as a critical strategic asset, and product lifecycle is an intelligent process.

The post Decision Criteria for Technology Commercialization of Medical Devices in 2026 appeared first on MedTech Intelligence.

While some wearables may be tailor made for trial use, they face challenges translating to real-world patient applications outside of a stringent trial setting, and vice versa. This creates a unique challenge for med-devs looking to bring their devices out of the trial setting and into patient care.

The post Continuous Cardiac Monitoring: Redefining the “End” of a Clinical Study? appeared first on MedTech Intelligence.

Rene Zoelfl, Global Industry Advisor for PTC's MedTech practice, shares how intelligent product lifecycle at Fresenius Medical Care connects cross-discipline teams through a digital fabric built on a shared data foundation.

The post Mastering MedTech Intelligence: The Intelligent Product Lifecycle at Fresenius Medical Care appeared first on MedTech Intelligence.

Device Makers are currently at an intersection of accelerated innovation and heightened regulatory scrutiny. Regulatory affairs stands in the center guiding operational resilience and a coherent regulatory strategy required by investors.

The post Navigating the Global Regulatory Landscape: A Foundation for Medical Device Commercial Viability appeared first on MedTech Intelligence.

The next phase of digital mental health adoption depends less on innovation and more on how the industry uses real-world evidence, builds reimbursement frameworks, and applies regulatory precedent to accelerate scale.

The post Demand for Non-Pharmacological Mental Health Needs a Delivery System appeared first on MedTech Intelligence.

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.

The post AI in Medical Devices: Safety Questions the Industry Can’t Afford to Ignore appeared first on MedTech Intelligence.

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

The post The Risk of Using a Device Off-Label Versus Contraindicated appeared first on MedTech Intelligence.

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?

The post The FDA Raised the Bar on MedTech Cybersecurity: Are Companies Ready? appeared first on MedTech Intelligence.

A recent survey of 2,000 UK patients found one in four patients (24%) already use AI for health guidance, and nearly one in three (30%) would be willing to consult AI or social media rather than wait to see a clinician. Despite this growing reliance on digital tools, the same survey revealed a disconnect in patient confidence, with almost 80% reporting that they do not feel fully in control of their healthcare. How might ChatGPT Health accelerate this shift, as well as what needs to happen to ensure AI adoption genuinely empowers patients rather than adding further complexity?

The post How ChatGPT Health is rewriting patient engagement appeared first on MedTech Intelligence.

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

The post Contract Manufacturer, Domico Med-Device, opens 23,000 sq ft Facility in Mexico appeared first on MedTech Intelligence.

Global look at regulatory compliance, guidance, trends and deadlines.

The post MTI Regulatory Roundup: global medical device regulatory update appeared first on MedTech Intelligence.

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.

The post R&D Operations Bottlenecks in Large Life Sciences Organizations: What can MedTech Leaders Do? appeared first on MedTech Intelligence.

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.

The post How is AI Enabling Darwinian growth for Life Science Professionals? appeared first on MedTech Intelligence.

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.

The post FDA Launches Technology-Enabled Meaningful Patient Outcomes (TEMPO) Pilot for Chronic Disease Technologies appeared first on MedTech Intelligence.