We want to share the highlights of China regulatory submission case from NMPA reviewers’ perspectives on positron emission/X-ray computed tomography (PET/CT system). Both technical...

Automated Wearable Breast Ultrasound System: Interview with Maryam Ziaei, CEO of iSono Health | Medgadget Posting....

Self-Regulating Footwear for Diabetic Foot Issues | Medgadget Posting....

The article provides an overview of the existing regulatory framework for heater-cooler devices. Table of ContentsThe Food and Drug Administration (FDA or the Agency),...

The new article describes in detail the procedure to be followed when applying for permission to conduct clinical trials in Pakistan.  Table of ContentsThe...

The article provides an overview of the regulatory requirements and procedures related to the importation of medical devices. The document constitutes a draft guidance...

Good design is good business strategy. Simply having stunning technology is not enough to achieve market success and sustained profitability. R&D might have developed a revolutionary innovation. But if you fail to package the innovation in a well-considered design that addresses both aesthetics and usability, you will leave a lot of money on the table. [...]

You might have a patent for a medical device, but is it really worth anything? If you focused on the wrong things when you...