[Inventory] 37 new medical devices approved by the FDA: blood glucose monitoring and heart rate sensors dominate
From January 2016 to January 9, 2017, MobiHealthNews reported 37 health-related apps approved by the FDA (US Food and Drug Administration). Among them, blood glucose monitoring and heart rate sensor APP dominated. With the improvement and regulation of the methods used by regulators to manage digital medical tools, we also saw more applications and software being approved. In the new year, some devices will Get deeper clinical level applications.
1. YuGo Microsoft Kinect Physiotherapy System
Israeli startup Biogaming has received FDA approval for its YuGo Microsoft Kinect physiotherapy system. Physiotherapists can use the system to create personalized game routines for patients, which can then be completed at home using the Xbox or a computer connected to the somatosensory device. The system tracks the behavior of the patient's treatment and automatically creates a record. The company may face a shutdown while waiting for FDA approval.
2. Dario blood glucose meter
Also in Israel, a blood glucose tester connected to a smartphone by Labstyle Innovations was approved. The device they developed was called Dario. The meter is synchronized with a companion app that is very small and fits into a person's pocket. Dario consists of a blood glucose meter, a disposable test strip box and a piercing device. Companion app for iOS and Android systems, including a nutrition guide, log and monitoring device. This app allows the user to see all of his own information and get some in-depth analysis based on the model of the information.
3. Triggerfish contact lenses
Sensimed of Switzerland announced that its Triggerfish connected contact lenses have been re-examined by the FDA. This device helps doctors track the progression of glaucoma patients. Incorporating sensor contact lenses will track and record changes in the user's eyeball for 24 hours. The data is transmitted wirelessly through the lens to a recorder that the patient can wear at the neck. At the end of the recording period, data can be transferred from the recorder to the doctor's computer via Bluetooth – meaning that the patient needs to go to the doctor's office to upload the data.
4. Remote patient monitoring system MoMe Kardia
MoMe Kardia, a remote patient monitoring system from InfoBionic in Massachusetts, USA, has been approved by the FDA and is not to be confused with AliveCor's products. The product is now also named after Kardia. MoMe Kardia is designed to monitor patients' electrocardiograms, breathing and exercise to diagnose arrhythmias. This lightweight monitoring device can be hung around your neck or worn on your belt. The current generation of products has been licensed by the FDA, but the equipment has not yet been commercialized.
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