Ashwini Sharan, M.D., Chief Medical Officer of the Neuromodulation Division at Medtronic, discusses the development of the company’s recently CE Marked Inceptiv closed-loop spinal cord stimulator system for chronic pain and how the company plans to further incorporate closed loop technologies in its neuromodulation pipeline.
How to choose the right sterilization method for silicone-based medical devices and a look at novel silicone technologies.
Orthogonal worked with Brian Binkowski, to gain a clearer picture of the state of SaMD approvals in the U.S. Following is what they learned about the rate of FDA approvals and clearances and which companies are having the most success getting their products cleared for the U.S. market.
Manufacturing jobs can be dangerous, but knowledge is the first step to minimizing the risks associated with these positions. This article discusses five of the most common safety hazards in medical device manufacturing, with tips on how to reduce the risk of employee injuries while maintaining productivity.
Emerging technologies, integrated vendor ecosystems and enhanced regulatory compliance will redefine care delivery and shape the needs of healthcare stakeholders. Following are six healthcare technology trends that will shape care delivery and the MedTech market in 2024.
Ensuring the safety and efficacy of healthcare products is of utmost importance. The clinical evaluation process of medical devices is vital for demonstrating the device’s safety and performance in accordance with the regulatory requirements. How are device makers navigating this complex process effectively.
While AI is already making significant contributions to pre-operative planning and post-operative analysis, its utilization intra-operatively remains a key area for further development. Collecting and utilizing comprehensive intra-operative surgical data, as facilitated by innovative applications of existing technologies such as light field, will pave the way for advanced AI applications in spine surgery.
The integration of artificial intelligence (AI) into breast cancer detection and treatment is already making a profound impact. AI-powered algorithms enhance early detection by analyzing vast amounts of data and identifying subtle abnormalities often invisible to the human eye. These technologies empower healthcare professionals to make informed decisions, improving the accuracy of diagnoses and tailoring treatment plans to the specific genetic makeup and health conditions of individual patients. This integration represents a paradigm shift in the cancer care continuum.
510(k) submissions have been a hot topic of late! Before you start your 510k submission make sure you’re aware of the pitfalls. Being responsible for writing and submitting a 510(k) can seem overwhelming – especially when tied to a scheduled product launch or marketing campaign driven by revenue goals. One of the most influential factors to a successful 510(k) submission is strategic planning.
Medical device regulations change frequently, so companies must be prepared to adapt. Following are strategies organizations can embrace to become more agile, allowing them to thrive amidst these increasingly rapid changes in innovation and regulation.
