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.

Whether gluing or molding, designers must carefully address each challenge to ensure reliable, consistent, and accurate manufacturing – and to avoid costly redesigns or patient safety risks later.

The post The Hidden Complexities of Medical Needle Design appeared first on MedTech Intelligence.

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.

The post Using AI and LLMs to fill in fragmented data gaps within complex critical care appeared first on MedTech Intelligence.

A digital companion, purpose-built for surgical patients’ pre- and post-operative journeys, is now an imperative for providers, payers, and medtech leaders aiming to achieve competitive differentiation, clinical excellence, and sustainable business value.

The post Digital Companion for the Perioperative Surgical Phases appeared first on MedTech Intelligence.

The medical device industry faces growing pressure to align U.S. and EU regulations, with the EU’s Medical Device Regulation (MDR) and the FDA’s Quality Management System Regulation (QMSR) setting new benchmarks.

The post Navigating U.S.-EU Medical Device Regulation: Innovative Strategies for Global Compliance appeared first on MedTech Intelligence.

President Trump’s 2025 executive order establishing artificial intelligence (AI) in pediatric cancer as a national priority marks a turning point in medicine. For decades, childhood cancer treatments have advanced slowly, constrained by limited data, small clinical trials, and therapies designed for adults. The convergence of AI and Functional Precision Medicine (FPM) now offers a path to faster, more accurate, and more personalized treatments for children, one that replaces population-based best guesses with evidence-driven precision care.

The post AI and Functional Precision Medicine: A Defining Moment for Pediatric Cancer Care appeared first on MedTech Intelligence.

The Service+Tech model embeds AI into the workflow of regulatory experts rather than treating technology as a standalone tool; an approach allowing organizations to adopt AI immediately, with no risk and no R&D investment, while keeping full confidence in the accuracy and regulatory readiness of submissions.

The post What is a Service+Tech Model? appeared first on MedTech Intelligence.

The collaboration aims to deliver real-time image processing, robotic control and cloud-enabled intelligence in a unified architecture.

The post EndoQuest to Advance Next-Generation Surgical Robotics powered by NVIDIA IGX Thor appeared first on MedTech Intelligence.

Trial will evaluate the safety and effectiveness of the AtriCure Isolator® Synergy™ EnCompass® clamp and AtriClip® Left Atrial Appendage Exclusion System to reduce the occurrence of new-onset atrial fibrillation in cardiac surgery patients.

The post AtriCure Announces the First Patient Treated in the BoxX-NoAF Clinical Trial appeared first on MedTech Intelligence.

Acquisition is expected to strengthens Thermo Fisher’s position in delivering clinical information to pharma and biotech customers.

The post Thermo Fisher Scientific to Acquire Clario to Provide Deeper Clinical Insights appeared first on MedTech Intelligence.

Examines the increasing strain on caregivers in home-based care models, the level of support they need for various stages of care, and how improved technological devices and infrastructure can help alleviate their burden.

The post The Overlooked Role of Family Caregivers in Home-Based Care: Addressing Challenges and Leveraging Technology appeared first on MedTech Intelligence.

Hospitals are adding more connected devices than ever before—from patient wearables to asset tracking systems. Yet this digital transformation is being bottlenecked by an antiquated power infrastructure dependent on single-use batteries that create waste, demand constant maintenance, and compromise device reliability.

The post Beyond Batteries: The Urgent Case for RF-Powered Medical Devices in Modern Healthcare appeared first on MedTech Intelligence.

Transaction Expected to Help Hologic Strengthen its Leadership in Women’s Health and Accelerate Growth

The post Hologic to be Acquired by Blackstone and TPG for up to $79 per Share appeared first on MedTech Intelligence.

Survey will assess demographics, salary rates, more.

The post AAMI and TechNation Collaborate to Survey Healthcare Technology Field appeared first on MedTech Intelligence.

AMA CEO says, "Augmented Intelligence will be a defining force in the future of health care, but right now we are barely scratching the surface of its potential."

The post AMA Launches Center for Digital Health and AI Innovation appeared first on MedTech Intelligence.

Asset acquisition expected to expand Merit’s Endoscopy portfolio with an innovative device to treat patients suffering from Barretts esophagus and other gastrointestinal disorders.

The post Merit Medical to Purchase Pentax Medical C2 CryoBalloon Technology appeared first on MedTech Intelligence.

Boston Sci acquisition expected to expand the neuromodulation offerings for people living with chronic pain.

The post Nalu Medical PNS System Acquired by BSCI appeared first on MedTech Intelligence.