If medical wearables want to save lives, they should be ‘invisible’
This article was originally featured on The Next Web. One of the latest updates to the Apple Watch included FDA-approved ECG monitoring, and it made waves in both the consumer and medical communities. Many people thought this was impossible. Some were worried about false positives. But most were excited about the potential good that a widely used […]
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 […]
The Wearable War Between Fitbit and Apple Could Save Lives
Apple has been aggressively moving into the medical development space, and it has transformed how many of us monitor our health. At the same time, the tech titan’s advancement into healthcare wearables has hurt Fitbit’s market share. The once dominant leader in digital fitness trackers is now making moves to take the crown back from […]
The Many Benefits of Connected Medical Devices
Medical facilities such as hospitals and clinics employ numerous diagnostic devices like thermometers, blood pressure cuffs, and pacemakers. Traditionally, the patient’s test data from these devices would be written in their chart. But as more hospitals and clinics embrace digital technology like electronic medical records (EMR), opportunities are opening up for connected medical devices to disrupt […]