Articles about fda

First ECG Device To Detect Three Heart Arrhythmias Cleared By FDA
Personal ECG devices can only detect just one kind of heart arrhythmia which is atrial fibrillation. That’s helpful in most cases but it doesn’t provide coverage for the other conditions which could prove to be just as dangerous. The FDA has now handed out its first clearance for a device that can detect three heart arrhythmias.

FDA Creates A Game That Will Help Kids To Stop Smoking
We all know that smoking is bad for your health and that kids smoking is also another issue. However the FDA thinks that they might have the answer to stop kids from smoking and that is through the creation of a PC and Xbox One game dubbed “One Leaves”. This game has been designed to scare kids into stopping.

FDA Restrictions On Genetically Modified Salmon Removed
The U.S. Food and Drug Administration has lifted an import alert on genetically modified salmon. This means that the genetically modified fish will eventually find its way into the country’s food supply. The import alert on AquaBounty’s AquAdvantage salmon eggs has been lifted. The fish can now reach the United States some three years after initial approval was granted by the FDA.

FDA Approves A Digital Inhaler With Built-In Sensors
These days a lot of our medical and health equipment is starting to get a lot more smarter and comprehensive in their functionality. For example back in the day, a weighing scale pretty much only told you your weight, but these days there are scales that can detect your body fat percentage, and some of them even work with your phone to set reminders to help log your progress and […]


Apple Watch Series 4 ECG Feature Was Almost Not Announced
One of the key features of the new Apple Watch Series 4 is the built-in ECG monitoring tool. According to Apple’s announcement, they claim that they were given a De Novo classification by the FDA for the feature, which allowed them to announce it at the event. However it seems that they almost couldn’t.

Apple Watch Heart Rate Study Reportedly Helped Win FDA Approval For ECG Feature
One of the key features of the Apple Watch Series 4 is how in addition to being able to measure your heart rate, a feature that has been around since the first iteration, it also comes with an ECG feature that basically takes heart measurements to more advanced levels than just how fast your heart is beating.

FDA Declares Impossible Foods’ Meat-Free Burger Safe To Eat
There seems to be a growing call to create sustainable food products and more recently, meat has been put on that list where scientists are working to grow meat in a lab without the need to kill any animals. In fact one company by the name of Impossible Foods has created a burger from plants that is said to taste, look, and feel like an actual burger.

FDA Approves First Implantable Continuous Glucose Monitoring Sensor
Having streamlined its regulations for digital devices about a year ago, the FDA has now approved a continuous glucose monitoring sensor that can be implanted into the patient’s body. This continuous glucose monitoring system called Eversense transmits data from a sensor implanted into the patient to a paired mobile app which lets users see their glucose levels on their mobile device. This is the first sensor of its kind that […]

FDA Approves Use Of AI Tool That Detects Wrist Fractures
To detect a fracture, you’d usually have to get the part of your body X-rayed, after which a doctor will then examine it to look for the fracture. Sometimes it can be missed, depending on how small the fracture can be, which is why it is good news that the FDA has approved the use of Imagen’s OsteoDetect.

FDA Approves First Drug That Helps Prevent Migraines
Migraines are more than just your typical headache and can get to the point where it prevents the person from doing anything for the rest of the day, or even days in some cases. There are several treatments available in the market, but they are not always effective. However the good news for migraine sufferers is that there is a new drug on the market that seems promising.

Amazon Hires Former FDA Official, Hints At Healthcare Plans
The healthcare industry is an extremely lucrative one, which is why many tech companies are venturing into it, Amazon included where according to a report from last year, the company has a “secret” health team that is looking to develop health-related products. Now according to a report from CNBC, Amazon is furthering their efforts with a new hire.

FDA Approves Shock Wave Device That Can Heal Wounds
There are a variety of ways to treat wounds, and the FDA has added a new way to that list by approving a treatment involving the use of shock waves. Developed by a company called Sanuwave, they have created a system called the Dermapace System that relies on “acoustic shock waves” to help heal wounds.

FDA Approves Digital Pill That Lets Doctors Track You
In an ideal world, people who are sick would take their medicine in a timely and consistent manner, but unfortunately in the real world, sometimes people forget to take their medication, might miss a dose or two thinking that it does not matter when it does. However that could change in the future, thanks to the FDA approving a digital pill that keeps track of you.

FDA Warns That Some Pacemakers Can Be Hacked
As our gadgets become increasingly connected, it does help make things more convenient, but at the same time it also means that there are more things in our lives that can be hacked. While a hacked smart thermostat might be considered annoying, a hacked pacemaker could be potentially deadly, and this is something the FDA is warning patients about (via Engadget).