Sensors: The Heart of Minimally Invasive Equipment Technology
Through the years, minimally invasive equipment technology has grown exponentially, offering new ways for doctors to diagnose and treat their patients.
How can antimicrobials prevent healthcare-associated infections?
In the past century, modern medicine has broken countless barriers towards a safer, more effective healthcare protocol.
Optimizing UX for the Internet of Medical Things
The implementation of the Internet of Things (IoT) in healthcare is growing rapidly. The industry is seeing an increased need for workflow optimization for electronic health records (EHRs), smart devices, wearables, patient portals, and remote healthcare access.
Pushing the Limits of Possibility in Medical Devices
In 2016, FDA approved Medtronic’s Micra, the firs […]
FDA Pilot Program Supports Streamlined Regulatory Submission Processes for Medical Device Manufacturers
The current U.S. regulatory framework for medical devices under the Center for Devices and Radiological Health (CDRH) includes extensive review of test protocols and results for each submission, a process that can be burdensome for both manufacturers and regulatory bodies.
Don’t Fear the Audit: Benefits of Good Quality Practices
Quality is a loaded word. For the general public, it connotes excellence, value, worth—all of which we strive for in our business. But for some in the medical device industry, it’s about bureaucracy, liability, and conflict. Maintaining a quality management system (QMS) per the expectations of regulatory bodies can be time-consuming, confusing, expensive, and tedious.
Stratasys and CollPlant Partner to Bioprint Breast Implants
When it comes to 3D printing in healthcare, a long-term goal has been to print human tissue that can potentially be grown into new organs. While 3D printing a new heart for a patient isn’t currently a reality, a growing number of companies are developing their own methods of printing tissue that can be used in implants, and, they hope, eventually organs.
Timeline Mystery for Updated EtO Rules
Thirty-six months (give or take a few) filled with controversy, legal battles, protests, anxiety, anger, and bewilderment—with likely more to come.
Study Suggests Increased Number of PMA Supplements Increase Recall Risk
a study published in JAMA Network Open reported that high-risk medical devices whose manufacturers file supplements to the FDA so modifications can be made to PMA-approved products are 30% more likely to be the subject of any recall and high-risk Class I recall.
Sensing Technology Drives the Future of Medical Care
One of the most exciting and transformative healthcare trends is the acceleration of connected health technology.