Results from the AVEIR DR i2i Investigational Device Exemption (IDE) study through three-months post-implant showed a 98.3% implant success rate for physicians and more than 97% of people had a successful atrio-ventricular synchrony, so that the upper and lower chamber were beating normally, despite different types of underlying slow heart rhythms.
As technology component pricing continues to rise, MedTech manufacturers are applying proven methods and exploring new approaches to maintain profitability and extend product lifecycles.
“We are pleased to expand our board of directors with two highly qualified executives from different sectors of the healthcare industry.”
Chris Fourment, MD, Senior Vice President, Clinical Strategy at Iterative Health, who specializes in structuring clinical trial programs, discusses the new FDA guidance on decentralized clinical trials, and how DCTs can help spur health and research equity.
Market research and forecasting help ensure that you are investing in a device or drug that is needed and will be well received. In this article, Sanobar Syed, Associate Director of Forecasting, Market Insights and Strategies, BeiGene, highlights strategies to support data collection for forecasting in emerging markets.
Veeva has launched a new tool to help MedTech developers identify and engage with healthcare experts and key opinion leaders.
The regulatory landscape for medical devices is rapidly evolving, catapulted most recently by European Union Medical Device Regulations (EU MDR). In this article, Monali Bhansali, Practice Lead of Regulatory Affairs at Tata Elxsi, highlights challenges and advancements in the MedTech regulatory landscape, and what the future has in store.
The FDA has updated the CDRH portal to allow users to track the progress of their pre-submissions. As of October 23, 2023, all 510(k) submissions, unless exempted, must be submitted as electronic submissions using FDA’s eSTAR portal.
Business strategy and forecasting influence several functional areas within an organization, including R&D, pipeline planning, revenue planning, inventory, resource and budget allocation, project prioritization, compensation plans, market access efforts, and more. These varied uses reflect the first major challenge of forecasting: meeting the needs of varied and diverse stakeholders. Following are three steps to make your forecasting efforts more effective.
On Monday, March 20, the EU MDR extension approved on March 7 came into effect following its official publication in the Journal of the European Union.
