Movano Health Receives FDA Clearance for EvieMED Ring
Rhea-AI Summary
Movano Health has received FDA 510(k) clearance for the pulse oximeter in its EvieMED Ring, opening up a $40 billion healthcare B2B market opportunity. The clearance enables the company to pursue opportunities in clinical trials, post-clinical management, and remote patient monitoring. The company is already in agreement phase with a large payor for a pilot study planned for early 2025 and in discussions with pharmaceutical companies and CROs. The EvieMED Ring combines medical-grade accuracy with comfortable wearability, measuring blood oxygen levels, heart rate, and additional wellness metrics. A pivotal study confirmed accurate readings across all skin tones.
Positive
- FDA 510(k) clearance obtained for EvieMED Ring's pulse oximeter
- Access to $40 billion healthcare B2B market opportunity
- Pilot study agreement with large payor planned for early 2025
- Selected for MIT study on long COVID and chronic Lyme disease
- Demonstrated accuracy across all skin tones in pivotal study
Negative
- None.
Insights
The FDA 510(k) clearance for EvieMED Ring's pulse oximeter represents a significant milestone for Movano Health, opening access to a
The company's strategic positioning is strengthened by existing partnerships with major healthcare players and planned pilot studies. Key differentiators include accurate readings across diverse skin tones and a comprehensive suite of wellness metrics. The potential for additional FDA clearances for respiration rate monitoring and future development of cuffless blood pressure and noninvasive glucose monitoring capabilities could substantially expand the company's market reach.
For a micro-cap company (
This FDA clearance transforms Movano's business model by enabling entry into lucrative B2B healthcare markets. The immediate pipeline includes
- A pilot study with a major healthcare payor for high-risk population management
- Potential partnerships with a global pharmaceutical company
- Collaboration with a leading CRO for clinical trials
- Participation in MIT's research on long COVID and chronic Lyme disease
The EvieMED Ring's superior compliance potential due to its comfortable design addresses a critical pain point in healthcare monitoring. This competitive advantage, combined with the device's comprehensive data collection capabilities, positions Movano to capture significant market share in the rapidly growing remote patient monitoring sector.
Company's first 510(k) clearance unlocks a TAM of
"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," said John Mastrototaro, President and CEO of Movano Health. "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."
In anticipation of an expected 510(k) clearance, Movano Health has been collaborating with a number of potential partners operating across the entire healthcare industry spectrum and expects its partner pipeline to expand further following the news of a clearance. The Company is currently in the agreement phase with a large payor for a pilot study with the EvieMED Ring planned for early 2025 related to the health management of high-risk populations and is also in discussions with a global pharmaceutical company and leading clinical research organization (CRO) to use the EvieMED Ring in upcoming clinical trials. In addition, the EvieMED Ring was recently selected for a groundbreaking MIT study on long COVID and chronic Lyme disease.
"This milestone marks the beginning of our plans to accelerate distribution of EvieMED. With the significant foundational work in achieving our first clearance now behind us, we are eager to continue to collaborate with the FDA on securing additional clearances including respiration rate and other critical analytes and diagnoses," continued Mastrototaro. "We also remain excited about the opportunities to leverage our proprietary radio frequency (RF) technology to address cuffless blood pressure and noninvasive glucose monitoring."
Pulse oximeters measure blood oxygen (SpO2) levels and heart rate, but conventional solutions have significant shortcomings and can be uncomfortable, discouraging compliance that is needed to ensure reliable information for evaluating a patient's health. The EvieMED Ring eliminates those limitations by combining the accuracy of a medical device with the comfort of a wearable that can be worn continuously, thanks in part to an award-winning design with a small gap in the ring surface and slight flex that accommodates finger swelling. A pivotal study also found that the EvieMED Ring produces accurate readings among users with darker skin tones as measured by the Fitzpatrick scale of skin color classification.
In addition, the EvieMED Ring collects wellness metrics including sleep, activity, temperature variability, calories burned and respiration rate that can give both patients and healthcare providers a broader picture of the user's overall wellness.
The EvieMED Ring will be available in eight sizes ranging from 5 to 12 to accommodate the widest selection of patients.
About Movano Health
Founded in 2018, Movano Inc. (Nasdaq: MOVE) dba Movano Health is developing a suite of purpose-driven healthcare solutions to bring medical-grade data to the forefront of wearables. Featuring modern and flexible form factors, Movano Health's devices offer an innovative approach to delivering trusted data to both customers and enterprises, capturing a comprehensive picture of an individual's health data and uniquely translating it into personalized and intelligent insights.
Movano Health's proprietary technologies and wearable medical device solutions will soon enable the use of data as a tool to proactively monitor and manage health outcomes across a number of patient populations that exist in healthcare. For more information on Movano Health, visit https://movanohealth.com/.
Forward Looking Statements
This press release contains forward-looking statements concerning our expectations, anticipations, intentions, beliefs, or strategies regarding the future. These forward-looking statements are based on assumptions that we have made as of the date hereof and are subject to known and unknown risks and uncertainties that could cause actual results, conditions, and events to differ materially from those anticipated. Therefore, you should not place undue reliance on forward-looking statements. Examples of forward-looking statements include, among others, statements we make regarding plans with respect to the commercial launches of the Evie Ring and EvieMED; our expectations regarding potential commercial opportunities; planned cost-cutting initiatives; anticipated FDA clearance decisions with respect to our products; expected future operating results; product development and features, product releases, clinical trials and regulatory initiatives; our strategies, positioning and expectations for future events or performance. Important factors that could cause actual results to differ materially from those in the forward-looking statements are set forth in our most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q, and in our other reports filed with the Securities and Exchange Commission, including under the caption "Risk Factors." Any forward-looking statement in this release speaks only as of the date of this release. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
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SOURCE Movano
FAQ
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