FDA cleared wearable technology, medical devices
We are 4 weeks ahead of the Medica fair in Düsseldorf, Germany. Medica is the world´s largest fair for medical and related health technology and features an impressive amount of 4,500 exhibitors and 130,000 visitors from 120 different countries.
WT will represent the wearable technologies ecosystem at Medica in hall 15, at booth A23. Over 15 exhibitors will demonstrate their product solutions and research capabilities on technologies from smart glasses, activity trackers, cloud technology software and much more.
Parallel to the WT show at the Medica fair many of the WT exhibitors will present their technologies at the Medicine & Sports conference on the 12th & 13th of November. For details, please click www.medicine-and-sports.com.
The insights gained in the medical world when it comes to wearables often cross over to the sphere of health & fitness. And the other way around: popular discussions like form factor as we have seen and heard about at the San Francisco conference in July last, have definitely gained territory in the design aspects of medical wearables.
Portable, wearable…invisible?
As the technologies advances and portability of these devices increase, the patients´ demand for discretion and non-disruptive functionality has found a resonating voice with engineers and developers.
Teardown.com and WT are collaborating to provide insight and analysis on the growing wearable and wellness medical device market. An example of some of the devices that we are looking at are included below. These devices have been either FDA-cleared or FDA approved.
The below images and specs have been provided to us by the engineers from Teardown.com, whose service is to provide in-depth technology and costing analysis on the latest devices on the market. The full reports are available for purchase; please contact the WT team directly.
1. Portable bio-data logger – by Zephyr FDA approved
Specs:
- Monitor Posture
- Monitor Activity
- Monitor ECG*
- Transmission Range: 10m
- Dimensions: 46.8 x 45.5 x 11.3mm
- Retail price ca $460
*ECG is indicative and should be used for troubleshooting purposes – comparison of noise levels etc., not for making a clinical diagnosis.
Functionalities:
The harness collects and analyses data for physiological monitoring of persons working in high-risk environments. It may be used by military & security professionals as well as firemen. The system operates in RF transmitting mode for live viewing of data or data logging mode.
What does it do for you? How to make it wearable?
The device is very light, strapped around your torso, directly onto the skin. They don´t become more typically wearable than this.
2. Portable glucose level monitoring – by Medtronic. FDA approved
Specs:
- Continuous glucose monitoring system
- Professional use only
- >3 days (or more) of patient interstitial glucose level monitoring
- Retail price for the entire kit (includes MiniLink™ wireless transmitter charging device, test plug, user guide, insertion device and sveral glucose sensors): ca. $1,625.
Functionalities:
- Battery powered digital recorder connected to a sensor is inserted into the patient’s abdome
- Docking station (MMT-7742) for refueling the battery & download data and import into software (proprietary Medtronic CareLink iPro™ Therapy Management software.
- Measurements: 35.8 x 28.8 x 9.4 mm
What does it do for you? How to make it wearable?
The device is watertight, discrete, small and light. Moreover it eliminates the time spent by the patient on glucose measurement as the device does it for the patient accurately and every 5 minutes. Safe convenience.
3. Pain relief with electrotherapy – by Omron. FDA cleared
Specs:
- Transcutaneous electric nerve stimulator (TENS)
- Program circle button controls 3 set programs for the arm, lower back and the leg/foot; arrows control 5 intensity levels
- 2 pads to attach to the body and apply the therapy not direcly on the skin (large surfaces)
- operated by 2 1,5 V batteries (AAA)=22.8 hours of continuous usage
- Retail price: ca. $30.
Functionalities:
- The device is used to relieve muscle and joint pain
- For professional use only
What does it do for you? How to make it wearable?
The device can be used on the skin and with the pads when used on larger surfaces.
What else is out there?
At the WT show at the Medica fair we look forward to report back to you after the event takes place – from November 12 until November 15th – on any other and new medical wearable technologies that we may find, originating from different countries and with different application fields.
