The reason behind non-USA medical device manufacturers seeking FDA 510(k) clearance
Many non-US medical device manufacturers pursue FDA 510(k) clearance to access the lucrative US market, the largest medical ...
Harvard Business School1 年
Association Between Regulatory Submission Characteristics and Recalls of Medical Devices ...
Everhart, Alexander O., Soumya Sen, Ariel D. Stern, Yi Zhu, and Pinar Karaca-Mandic. "Association Between Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) ...
来自MSN10 个月
Zynex’s new NMES device secures FDA clearance
The US Food and Drug Administration (FDA) has approved medical technology company Zynex’s next-generation neuromuscular electrical stimulation (NMES) device, the M-Wave. This device is intended ...
Business Wire11 天
Mindset Medical Announces FDA Clearance for its Contactless Pulse Rate Measurement Device
(“Mindset Medical” or the “Company”), a digital health company, today announced FDA 510(k) clearance for its contactless pulse rate measurement device, the Informed Vital Core ...