New Wearables Approved For U.S. Market

By Christine Kern, contributing writer

ViMove, Personal KinetiGraph are among the new products receiving FDA approval.

The field of technology-assisted medicine got a little more crowded recently when the U.S. Food and Drug Administration approved the sale of a wrist device that can monitor a Parkinson’s disease patient’s condition. The device, produced by Australian company Global Kinetics Corporation, is called the Personal KinetiGraph and collects data that doctors can use to plan therapeutic treatments.

Already available in Australia, the KinetiGraph can now be sold in the United States, thanks to the FDA’s approval. 510K clearance is required for certain types of medical devices before a manufacturer can introduce a device into commercial distribution for the first time in the U.S. market.

The KinetiGraph, according to its manufacturer, “offers comprehensive, automated reporting of a Parkinson’s disease patient’s movements so that neurologists and other physicians can more easily identify changes in movement symptoms to assist in decisions to optimize therapy.”

Earlier this year, the FDA approved several others pieces of wearable medical technology. In February, it approved two patient-monitoring watches manufactured by CamNtech. Essentially functioning as wearable activity logs, CamNtech’s devices gather data on vital signs and body movement. The data can be transferred to a computer via USB and sent to the patient’s doctor for analysis.

In July, the Australian company dorsaVi Limited received approval from the FDA to sell its ViMove muscle activity monitor in the U.S. The product “consists of wearable sensors that are placed on the body to measure movement and muscle activity,” the company said in its press release. “ViMove can monitor their everyday activities, and provide immediate biofeedback to the patient and a concise report for the healthcare practitioner.”

In recent months, the FDA has also approved devices with medical applications for mammography, obstructive sleep apnea, HPV, and Hepatitis B.