Ensuring that proven therapies can be delivered safely and accessibly to the patients who need them provides opportunity in what we innovate and in how broadly those innovations can reach.
The post An Endovascular Approach to Neurological Diseases Can Shift the Treatment Paradigm appeared first on MedTech Intelligence.
Without formal policies and governance, MedTech organizations face risks to intellectual property, product quality, and ultimately patient safety. Thoughtful AI governance enables development teams to capture efficiency gains while maintaining the rigor that the industry demands.
The post Why Gen AI is a Win for MedTech: And, How to Unlock its Potential with the Right Policies appeared first on MedTech Intelligence.
In healthcare, a cyber vulnerability is not just an IT problem. It can quickly become a patient-care problem.
The post The Medical Device Cybersecurity Gap Hiding in Plain Sight appeared first on MedTech Intelligence.
Healthcare environments are dynamic with patient populations, clinical practices and data collection methods continuously evolving. Similarly, effective AI systems depend on more than performance at initial deployment. They must be monitored and managed throughout their lifecycle to remain reliable, clinically relevant, and safe.
The post Maintaining trust in medical AI: Monitoring and managing model lifecycle appeared first on MedTech Intelligence.
Next generation mitral valve, designed to facilitate patient lifetime management reports first uses in sternotomy, Minimally Invasive Cardiac Surgery (MICS) and robotic cases.
The post Medtronic’s Updated Mitral Valve, Mosaic Neo, Gets FDA approval appeared first on MedTech Intelligence.
SUNRISE-II feasibility trial marks the company’s entry into U.S. clinical development, advancing minimally invasive, anesthesia-free treatment approach
The post Sonire Therapeutics Initiates First U.S. Clinical Study of Ultrasound-Guided HIFU Therapy for Pancreatic Cancer appeared first on MedTech Intelligence.
Edwards announced 10-year results from the COMMENCE aortic trial, reinforcing the long-term durability and sustained performance of its proprietary RESILIA tissue.
The post Edwards Lifesciences Shares Ten-Year Pivotal Data Supporting Long-Term Durability of Resilia Tissue appeared first on MedTech Intelligence.
The deal would fold the FDA-cleared Hotwire system, and the team behind Farapulse, into J&J's expanding cardiac ablation business.
The post Johnson & Johnson Enters Agreement to Acquire Atraverse Medical appeared first on MedTech Intelligence.
The TAVVE study will begin later this year with ten patients, whose 30-day safety results will be submitted to the FDA.
The post enVVeno Medical Receives FDA IDE Approval for Non-Surgical Replacement Venous Valve appeared first on MedTech Intelligence.
Following recent FDA clearances, Medtronic is accelerating access to integrated planning, navigation, and robotics platform across Europe.
The post Medtronic Gains CE Mark for Stealth AXiS surgical system appeared first on MedTech Intelligence.
CathWorks FFRangio System employs drug-free, wire-free technology for comprehensive physiological assessment.
The post Medtronic Continues Cardiovascular Care Growth with Completion of CathWorks Acquisition appeared first on MedTech Intelligence.
Validation documentation should define process parameters, monitoring strategies, and operating ranges that can support future production increases. How does a practical framework for validation, revalidation, and process control help during medical device scale-up?
The post From Prototype to Production: Building a Validation Strategy That Scales with Manufacturing Volume appeared first on MedTech Intelligence.
Companies developing or deploying AI systems now face increasing scrutiny around risk classification, transparency and lifecycle governance. An AI management system (AIMS) aligned with ISO/IEC 42001 provides a structured way to address these challenges while significantly improving efficiency, quality, and innovation outcomes — and ensuring AI system are effective, safe, compliant, and trustworthy.
The post Managing AI in Medical Technology: From Innovation to Compliance appeared first on MedTech Intelligence.
No longer a horizon technology, Artificial Intelligence in healthcare has reached a level of real-world performance that makes clinical value demonstrable at a critical time in healthcare – a time of clinician shortages, backlogs, and rising costs that have made access to treatment a challenge.
The post Seven Things Every Medical Device Manufacturer Must Know Before Integrating AI appeared first on MedTech Intelligence.
MedTech leaders must find a balance between the slow, careful world of medicine and the fast-paced expectations of investors. Real success comes from choosing high-quality science over quick shortcuts, as being thorough is the only way to build lasting trust and reach the market.
The post The Structural Tension at the Heart of MedTech appeared first on MedTech Intelligence.
Protect patient data with medical IoT security. Learn how AI, Zero Trust, and encryption can prevent cyber threats and secure healthcare IoT devices.
The post Cybersecurity Tactics for Medical IoT Devices appeared first on MedTech Intelligence.
Many challenges of designing and validating pediatric digital health devices are over-looked across developmental stages. Regulatory strategy, human factors, software architecture, and algorithm performance are critical consideration in dynamic patient populations.
The post From Toddlers to Teens: The Hidden Complexities of Bringing Pediatric Wearables to Market appeared first on MedTech Intelligence.
A long-overdue push to reduce administrative friction, improve access to patient data, and move the system away from workflows that continue to waste time for both patients and providers.
The post Interoperability was Never the Finish Line in Healthcare appeared first on MedTech Intelligence.
New pathway cuts red tape and brings predictability to Medicare coverage for Breakthrough Devices.
The post CMS, FDA Announce RAPID Coverage Pathway to Accelerate Device Reimbursement appeared first on MedTech Intelligence.
Having already set expectations around the structured capture of medical device safety data, regulators are now ready to analyze related insights, and they expect device manufacturers to match this capability.
The post Beyond Reporting: Realizing Continuous Safety Surveillance for Medical Devices appeared first on MedTech Intelligence.
Innovation, implementation & utilization of medical technology
