The company says 510(k) clearance will allow it to pursue multiple business opportunities pertaining to remote patient monitoring and clinical trials.
Wearables maker Movano Health announced it received FDA 510(k) clearance for its health monitoring wearable, EvieMED Ring.
EvieMED Ring is a smart ring that combines medical and wellness metrics, including blood oxygen levels, heart rate and metrics related to energy, logging of mood, sleep and activity.
The publicly traded company touts that receiving FDA clearance will allow it to pursue business opportunities in clinical trials, remote patient monitoring and post-clinical trial management.
In a statement, Movano said it is currently in talks with a large payor to participate in a pilot study with the EvieMED Ring in 2025 and a global pharma company to use it in upcoming clinical trials.
Additionally, the ring is being used for continuous health monitoring in a clinical trial at the Massachusetts Institute of Technology (MIT) studying long COVID and chronic Lyme disease.
“We launched the Evie Ring in the consumer wearable market, but our broader goal has always been to provide a clinical-grade device for B2B channels,” John Mastrototaro, president and CEO of Movano Health, said in a statement.
“This FDA 510(k) clearance marks a major milestone for the company and expands our reach to pharmaceutical companies, medical device manufacturers and payors looking for a more accurate, consistent and comfortable health monitoring solution that would help improve compliance by fitting easily into patient lifestyles.”
THE LARGER TREND
In October, Movano opened an investigation into apparent manipulation in trading of its common shares a week after an SEC filing showed shareholders approved a 1-for-15 reverse stock split.
The company announced the internal investigation revealed that a large number of single=share transactions were executed in an attempt to take advantage of the reverse split shares at the beneficial owner level, though the activity was detected before any round-up shares were issued.
Movano Health went public in March 2021. Its stock (NYSE: MOVE) is currently trading on the NYSE at around $5.52 per share.
The company also offers its Evie Ring, a smart ring designed specifically for women, which includes an open design that accommodates different finger sizes and an app that allows users to track and understand metrics related to their health and wellness.
The ring collects and correlates information to identify patterns in a woman’s menstrual cycle, sleep, energy, heart health, mood and progress toward a wearer’s defined goals over time.
The company halted the availability of the Evie Ring earlier this year due to supply chain challenges and to address customer feedback. It relaunched in September with an app that allowed users to garner deeper personalized health insights through AI-enabled pattern recognition.
Source: Mobihealth
