A Brief Overview of FDA Medical Device Regulations — Part 2
Welcome back to the final entry of our two-part overview of FDA regulations for medical devices! In the first part of our series, we covered medical device classifications and listings, establishment registrations, premarket notifications, and premarket approvals. In case you need a quick review, you can check it out here. We’ve got a lot of […]
A Brief Overview of FDA Medical Device Regulations — Part 1
To develop, manufacture, and distribute health tech devices in the United States, innovators must have a thorough understanding of regulations and compliances. In the first entry of this two-part series, we provide a brief overview of the first few FDA regulations for medical devices. A Necessity for Safe Innovation Any technological innovation or advancement in […]
Can the FDA and MedTech Work Together?
Medical technology is advancing at an accelerated rate as patients seek cheaper, more sophisticated, long-term options for healthcare. But as MedTech develops, the U.S.’s Food and Drug Administration (FDA) is a big barrier to success for many MedTech firms. In fact, as of February 19th of this year, the FDA removed more than 2,500 MedTech firms […]
MedTech Startups Like EverlyWell Bring Lab Testing Home
https://staging.dogtownmedia.com/app-developers-austin/ As mobile app developers know, even if you have health insurance, getting blood work done can be expensive. The initial visit to the doctor’s office is inevitably followed by a bill from a clinical lab that sometimes adds up to hundreds of dollars. Fortunately, several mHealth startups are coming up with practical, money-saving solutions […]
Mobile Healthcare Apps Are Creating Chaos and Opportunity
With an explosion of mobile healthcare apps hitting the software market, doctors and industry insiders are wondering how to vet and regulate them. As Dr. Douglas Mogul, a pediatrician at Johns Hopkins says, “People should have full disclosure over what the app can do. If it’s going to make a claim about health, that claim […]