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Movano Inc. (Nasdaq: MOVE), operating as Movano Health, is a health-focused technology company dedicated to revolutionizing the way we manage and monitor our health metrics. Founded in 2018 and headquartered in Pleasanton, California, Movano is committed to developing healthcare solutions that bring medical-grade, high-quality data to consumer health devices. The company's flagship product, the Evie Ring, is a wearable designed specifically for women to track a comprehensive array of health metrics including resting heart rate, heart rate variability (HRV), blood oxygen saturation (SpO2), respiration rate, and skin temperature variability. It also monitors period and ovulation tracking, menstrual symptom tracking, steps, active minutes, calories burned, sleep stages and duration, and mood tracking.
Movano Health has made significant strides in advancing its Evie Ring technology, as evidenced by a recent hypoxia trial conducted in collaboration with the University of California, San Francisco (UCSF). The study confirmed that the accuracy of Evie's pulse oximeter exceeds FDA guidelines. This milestone underscores the company's objective to achieve FDA clearance for the Evie Med Ring, a medical-grade version of the wearable. The Evie Med Ring aims to provide a seamless blend of accessibility, personalization, and medical reliability, significantly differentiating itself from existing wellness solutions.
In addition to its technological advancements, Movano Health recently secured a strategic investment from a tier-one multi-billion dollar medical device company. This partnership, along with a $24 million capital raise, ensures financial stability and accelerates the commercialization of Movano's proprietary technologies. The company has also entered into agreements to explore future collaborations for the development and commercialization of their healthcare solutions.
Movano Health's commitment to innovation extends to strategic collaborations with prestigious institutions like MIT. The company’s Evie Ring is being utilized in the MAESTRO study to understand long COVID and chronic Lyme disease, providing continuous, reliable data that could reshape approaches to these debilitating conditions.
For more information on Movano Health and their latest updates, visit here.
Movano Health (Nasdaq: MOVE) provided an update on the FDA review of its EvieMED Ring. The company received additional clarifying questions from the FDA related to medical aspects of the device, as part of the final phase of its 510(k) application review process. Movano Health remains optimistic about EvieMED's potential for 510(k) clearance after securing a positive resolution to initial FDA questions about wellness features and metrics.
The EvieMED Ring is designed to provide medical device functionality through pulse oximetry, along with wellness metrics for sleep, activity, and mood tracking. Separately, Movano Health successfully resumed direct-to-consumer orders for the Evie Ring on September 17, 2024, with initial positive response to product and operational improvements.
Movano Health (Nasdaq: MOVE) has relaunched its Evie Ring, the first smart ring designed for women, with significant upgrades. The ring now features enhanced AI-powered health insights, improved sleep and heart rate measurements, and a unique trend analysis feature. The updated app identifies patterns over time, correlating menstrual cycle, heart health, sleep, mood, and energy. Key improvements include:
1. Personalized health insights through AI-based pattern recognition
2. A Daily Summary display showing progress towards multiple goals
3. More accurate sleep data and heart rate measurements during activity
4. Upcoming features like Auto Activity Detection and an Android app version
The Evie Ring is priced at $269 with no subscription fees, offering 4+ days of battery life and a 60-minute recharge time.
Movano Health (Nasdaq: MOVE) has made significant progress in the FDA review process for its EvieMED Ring, a wearable device offering both medical and wellness functionalities. Following a productive meeting with the FDA on August 15, 2024, the company received positive feedback on the ring's wellness features and metrics. Movano Health is now advancing to the final phase of the 510(k) clearance process for the device's pulse oximetry feature.
The company filed an updated 510(k) application on April 21, 2024, and addressed additional FDA inquiries about wellness aspects in July. Separately, Movano Health plans to resume direct-to-consumer (D2C) orders for the Evie Ring on September 17, 2024, incorporating product enhancements and improved operations processes.
Movano Health (Nasdaq: MOVE) reported Q2 2024 results and provided a business update. Key highlights include:
1. Preparing for September 17th Evie Ring back in stock date with enhanced product experience and operations.
2. Announced brand partnership with digital creator Heidi D'Amelio.
3. Pursuing FDA 510(k) clearance for EvieMED Ring and B2B commercial agreements.
4. Closed a $24.1 million private placement in April 2024.
5. Shipped 1,837 Evie Rings in Q2 2024.
6. Reported an operating loss of $6.4 million in Q2 2024, compared to $7.4 million in Q2 2023.
7. Total cash and cash equivalents at June 30, 2024, were $16.9 million.
The company is focusing on improving consumer experience, securing FDA clearance, and advancing clinical studies for cuffless blood pressure and noninvasive glucose monitoring.
Movano Health (Nasdaq: MOVE), a health technology pioneer, has announced its plans to release second quarter 2024 financial and operating results on Wednesday, August 14, 2024, after market close. The company will host a conference call and live audio webcast at 2:00 PM PT / 5:00 PM ET on the same day to discuss the results and provide a business update.
Investors and interested parties can access the live webcast through the provided link or on Movano Health's investor relations website. For those preferring to join by phone, domestic callers can dial 1-877-407-0989, while international callers should use 1-201-389-0921. A convenient Call Me link is also available for instant dial-in. An archived version of the webcast will be accessible on the company's website for two years following the event.
Movano Health (Nasdaq: MOVE) is progressing with its FDA 510(k) clearance process for the EvieMED Ring, a wearable device offering both medical and wellness functionalities. The company filed an updated 510(k) for the ring's pulse oximetry feature on April 21, 2024, initially expecting a decision by July 2024. After addressing minor clarifications in May and June, the FDA requested additional information about EvieMED's wellness aspects in late June.
Movano Health provided a draft response on July 10 and is scheduled to meet with the FDA in mid-August to discuss the inclusion of wellness features in the device. CEO John Mastrototaro expressed confidence in the clinical evidence provided for the pulse oximetry feature and the company's commitment to collaborating with the FDA. The company will report its Q2 2024 financial results on August 14, 2024.
Movano Health (Nasdaq: MOVE) announced that Dr. Fatima Rodriguez and Matt Hughes will join the company's virtual event on July 11, 2024. The event, titled 'B2B: The Next Wearables Boom,' will focus on enterprise applications of wearables in healthcare. Dr. Rodriguez, a Stanford University expert in cardiovascular medicine, and Hughes, a managing partner at Allele Capital, will join Movano's CEO John Mastrototaro and Chief Commercial Officer Michael Soule to discuss the potential and future of Movano's Evie enterprise solutions. This panel aims to explore how advanced wearable technology can enhance cardiovascular disease prevention, patient empowerment, and health equity.
Movano Health (Nasdaq: MOVE) has announced significant advancements in the accuracy of its heart rate in motion algorithm by integrating deep learning into its processing. This enhancement, directed by Founder and CTO Michael Leabman, aims to improve the reliability of wearable health monitors like the Evie Ring. A recent study involving 65 subjects performing various activities showed a high correlation between the Evie Ring's heart rate measurements and those of a Polar H7 chest strap, indicating the algorithm's improved accuracy. Movano plans to apply this deep learning technique to other health metrics such as sleep, respiration, heart rate variability, and blood oxygen saturation.
MIT has partnered with Movano Health for a landmark study, dubbed the MAESTRO study, to investigate long COVID and chronic Lyme disease using Movano's Evie Ring. The study will enroll 300 adults aged 18-35 across four cohorts: acute Lyme disease, chronic Lyme disease, long COVID, and a control group. The collaboration aims to leverage the Evie Ring's continuous health monitoring capabilities to collect extensive data on vital signs and wellness. This initiative seeks to enhance understanding and treatment of these conditions affecting millions of Americans. Movano Health's CEO highlighted the significance of this partnership in ushering in a new era of personalized patient care and scientific discovery.
Movano Health (Nasdaq: MOVE) reported its Q1 2024 financial results, focusing on key initiatives such as enhancing the Evie product, securing FDA 510(k) clearance for the Evie Med Ring, and advancing cuffless blood pressure studies.
The company recently closed a $24 million private placement and generated $852,000 in revenue, shipping 5,305 Evie Rings in Q1. However, it reported an operating loss of $5.8 million, a slight improvement over the $7.2 million loss in Q1 2023. Total cash and equivalents stood at $2.1 million as of March 31, 2024.
Recent milestones include successfully submitting clinical trial results for the Evie Med Ring and planning a new blood pressure study for June 2024. The company expects an FDA decision on the Evie Med Ring in July 2024.
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