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.
GLD Announces Successful Closing of Seelos Assets; Includes Ketamine and Trehalose Programs Advancing into Phase 3 Clinical Trials.
The post Seelos Therapeutics, Inc. Assets, Acquired through Bankruptcy appeared first on MedTech Intelligence.
Converting promising technologies into durable outcomes, experience, and cost at scale with evolving technologies and disruptive innovation.
The post Disruptive Innovation in MedTech: Evolving Characteristics and Modern Realities appeared first on MedTech Intelligence.
Seek partners who can see your vision — the full picture, anticipate challenges, and help you navigate complexity with confidence.
The post Product Development Outsourcing Needs Speed, Safety & Certainty appeared first on MedTech Intelligence.
Sunrise Labs rebrands as Suntra Medtech Solutions with a strategic repositioning to meet the demands of a rapidly transforming healthcare industry where speed, precision, and integrated thinking are more essential than ever.
The post Sunrise Labs Rebrands as Suntra MedTech Solutions™ appeared first on MedTech Intelligence.
Notified bodies receive numerous questions from legal manufacturers during technical assessments. We cannot always answer them for individual legal manufacturers because this would constitute consultation.
The post 4 FAQs to Notified Bodies appeared first on MedTech Intelligence.
To navigate increasingly complex global regulations and rising market expectations, organizations are embracing the Intelligent MedTech Lifecycle: a unified, data-driven approach that breaks down silos and drives agility across the entire product journey.
The post Managing MedTech Cost Pressures With Data-Driven Lifecycle Intelligence appeared first on MedTech Intelligence.
Some manufacturers are now embedding CER processes within broader regulatory operating systems, integrating authoring, surveillance, and quality management to enable real-time adaptability. Artificial Intelligence (AI) , in particular, is playing an increasingly critical role in helping manufacturers meet expanding regulatory expectations.
The post Beyond Automation: How AI Transforms Clinical Evaluation Reports into Strategic Regulatory Assets appeared first on MedTech Intelligence.
Innovation, implementation & utilization of medical technology
