FeverScout, a medical-grade wearable device certified by FDA, has passed the final stage of listing

VivaLnk, a digital medical company founded by Chinese in Silicon Valley, recently Received a notice from the US Food and Drug Administration (FDA), the company’s product “FeverScout” (Children’s Smart Thermometer) has passed the 510(k) certification of the US FDA, and the certification number is “K162137”. After passing this FDA certification, it marks that VivaLnk is qualified to sell FeverScout in the US market, which will have a positive impact on expanding the US market, and will further expand the sales area of ​​the product in the international market.

FeverScout is a small patch made of flexible silicone and polyurethane containing VivaLnkeSkin. VivaLnkeSkin is a soft membrane embedded with planar microsensors that monitor body temperature. The FeverScout patch is only half the size of a palm, and it is attached to the child’s armpit when in use. After pairing with a mobile phone via Bluetooth, it can realize near-distance 24-hour uninterrupted body temperature tracking, accurate to 0.1 degrees. And when the body temperature exceeds the normal range, the alarm can also be sent through the mobile phone. It is very convenient for parents who need to repeatedly measure the body temperature when their children have a fever or who cannot take care of their children because of business. The app also tracks body temperature over time, allowing users to jot down food eaten, doses of medication taken, and more, all without waking children up or putting things in their mouths.

Wearable devices are increasingly permeating our lives, and many people now like to wear smart watches to live a healthier life, but there is a line between casual wearable devices and serious medical devices. The sale of the former does not require supervision, while the latter needs to comply with the regulations of the US Food and Drug Administration (FDA). The U.S. FDA includes medical wearable devices and Apps in the management of medical devices, and they need to pass technical and effectiveness tests before they can be listed. The threshold set up by this is to curb disorderly competition in the market; second, to protect the safety and health of patients; third, It is confirmed the curative effect. FDA has always been regarded as the benchmark for food and drug safety supervision, and with its rigorous, strict and strict style, it has set a benchmark for global food and drug supervision. FeverScout can pass the FDA certification, which shows the excellent quality of this product.

It is reported that VivaLnk, the company that developed FeverScout, was founded by Dr. Li Jiang in Silicon Valley, USA. In the early days of the company’s establishment, it worked closely with top international IT companies, and Google and Motorola were its important customers and strategic partners. The VivaLnk team also includes the chief cardiologist of UCSF, a doctor of medical engineering in the United States, a doctor of mechanical engineering in Japan, etc., who are extremely professional in the medical field. Now VivaLnk has 7 unique technology patents belonging to the company, especially VivaLnk’s unique eSkin technology, combined with the Internet of Things integrated circuit chip design, flexible substrate production process, electronic skin system design standards, wireless communication, sensing and biological The latest achievements in technology make the ultra-thin, soft and stretchable electronic patch closely adhere to the skin, so as to realize the extraction and monitoring of effective physiological parameters of the human body. This technology is also considered an important way to balance usability and precision.

At present, VivaLnk has set up an office in Hangzhou and participated in the National Maternal and Child Summit. At the meeting, FeverScout won the Most Potential Award. In addition, they have also reached strategic cooperation with Chinese smart medical institutions, hospitals and research institutes. It is believed that in the near future, FeverScout will also appear in the Chinese market. Of course, in today’s increasingly globalized world, mothers who want to have a sneak peek at FeverScout can also purchase it through overseas shopping channels.