FDA Approved Health Tech
In recent years, there have been some great advances made in health care technology in the Internet of Things as well as in iOS Apps that accompany various devices and apps. The FDA makes a distinction between wellness or fitness technology and apps vs healthcare tech and apps, there are basically two categories for this technology. The FDA is more concerned with the later since health apps are categorized as those that diagnose, track or treat disease, while wellness apps enhance or track the overall health of the user so if an app or device is not used to diagnose or treat a medical condition it does not require FDA approval or clearance based on the FDA current guidance for mobile medical applications. We may very well see FDA approval for various fitness and wellness technology moving forward. About 20 or so devices/apps receive FDA approval each year. The following is a partial list of FDA approved health tech available now.
St. Jude Medical™ Invisible Trial System
This past year St. Jude Medical, Inc. announced FDA approval of the St. Jude Medical™ Invisible Trial System. The system is fully wireless and leverages Apple™ technology for both the patient and physician controllers. It’s designed to provide patients a more improved and discreet spinal cord stimulation (SCS). For many patients, SCS therapy can be an effective option for managing chronic pain. The therapy relies on a small implanted device and thin wires (known as leads) to deliver low levels of electrical energy to mask or interrupt pain signals as they travel along nerve fibers to the brain, which reduces the sensation of pain. The system relies on Bluetooth® wireless technology to provide patients a safe, secure and entirely wireless SCS trial experience. Rather than a complex controller, the St. Jude Medical Invisible Trial System provides patients with a more intuitive iPod touch™ digital device as a controller, while physicians will utilize an iPad mini™ digital device to program and evaluate their patient’s therapy.
Mobile MIM was the first medical app to be included in the iTunes store. It is a diagnostic imaging app for the iPad®, iPhone®, and iPod touch®. Imaging professionals now have a portable solution away from their workstations. Consult with peers for difficult cases. Review X-rays and ultrasounds. Reduce image distribution delays. Enhance referring physician and patient interaction. Bypass the cost and headache of CDs.
ResolutionMD® enables doctors to securely view patient images and reports from a wide variety of computers and mobile devices, collaborate with other practitioners and diagnose from any location. Whether you are a single facility or a large healthcare system with tens of thousands of users, ResolutionMD is an FDA class II cleared solution for seamless image access across multiple departments from web and mobile devices.
BlueStar from WellDoc
BlueStar is the First FDA-Cleared, Mobile Prescription Therapy for Type 2 Diabetes with Insurance Reimbursement. BlueStar is a medical product that requires a prescription from a licensed healthcare provider and is cleared by the FDA for use by adults with type 2 diabetes. “Healthcare is on the cusp of a revolution where new technologies can address epidemics, like diabetes, in ways never before imagined,” said Rick Popp, director of employee benefits at Ford Motor Company. “We are excited about the possibilities of a product like BlueStar that may benefit our employees who face the daily challenges of living with type 2 diabetes. It’s another example of Ford going further.”
AirStrip ONE® provides a single, data platform that connects clinicians with the right information at the right time, via the most convenient device at hand. It connects clinicians with patient data and with each other and enables workflow automation and collaboration at the moment of care. AirStrip ONE® is a catalyst for care pathway and workflow innovation across diverse service lines and care settings.
The Dexcom G5 Mobile app
Dexcom is the first completely mobile continuous glucose monitoring system. The Bluetooth® transmitter reads your glucose data continuously and is sent wirelessly from the Dexcom G5 Mobile transmitter to your compatible smart device. The Dexcom G5 Mobile app gives you the information you need at-a-glance. Just run the Dexcom G5 Mobile app and stay one step ahead of your diabetes. With readings every 5 minutes, Dexcom G5 Mobile will give you the glucose information you need so you can focus on where you’re headed in life!
Qardio received FDA approval for it’s QardioArm blood pressure monitor. We covered the QardioArm in an article awhile back and it performs as advertised.
Nexus6 a New Zealand-based medical device company received FDA approval for its smartphone-connected inhaler, SmartTouch. This is a class II medical device. It has been cleared as a prescription based Metered Dose Inhaler (MDI). Its intended uses are in clinical trials, clinical practice, and for patient self-management.
Multi-parameter Mobile CareGuide1 provides continuous non-invasive monitoring of muscle oxygen saturation (SmO2) and muscle pH (pHm). The Multi-parameter Mobile CareGuide sensor continuously provides data and displays on a patient monitor or smart device.
Kinsa Health received FDA approval for its Kinsa smart thermometer. The Kinsa Smart Stick can be used, orally, underarm, or rectally. The Kinsa Smart Ear takes a temperature reading in one minute by inserting in the ear. Both devices transmit data to a companion smartphone app.
- St Jude Medical, Inc. Press Release