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.
Shuvo Roy, Ph.D., Professor of Bioengineering at UCSF and Technical Director of The Kidney Project, and his research partners have developed an artificial kidney constructed of semiconductor silicon wafers that remove waste and toxins from the blood and a cell therapy unit that replicates other kidney functions. Their prototype, powered entirely by blood pressure, filtered blood and created urine in a pre-clinical trial.
As technology component pricing continues to rise, MedTech manufacturers are applying proven methods and exploring new approaches to maintain profitability and extend product lifecycles.
Pulvinar Neuro has received a $3 million dollar NIH grant to further its research on noninvasive transcranial alternating current stimulation for the treatment of depression.
“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.
In leveraging the valuable insights delivered by real-time location systems (RTLS) technology, hospitals and healthcare facilities are able to undergo the kind operational overhaul they so desperately need, boosting ROI while simultaneously allowing for better working conditions for staff as well as more focused, immediate care for patients.
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.
