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Movano Health Receives FDA Clearance for EvieMED Ring

Movano Health Receives FDA Clearance for EvieMED Ring

Movano Health獲得FDA對EvieMED戒指的批准
PR Newswire ·  12/02 22:22

Company's first 510(k) clearance unlocks a TAM of $40 billion in healthcare B2B opportunities

公司的第一個510(k)清除打開了一項400億美元的醫療健康B20億機會

PLEASANTON, Calif., Dec. 2, 2024 /PRNewswire/ -- Movano Health (Nasdaq: MOVE), a pioneer in health technology, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for the pulse oximeter in its EvieMED Ring. The clearance enables Movano Health to pursue multi-billion dollar business opportunities for health monitoring solutions needed for applications such as clinical trials, post-clinical trial management, and remote patient monitoring for both healthcare providers and payors.

加利福尼亞州普萊森頓,2024年12月2日 / PRNewswire / - Movano Health(納斯達克股票代碼:MOVE), 作爲健康科技的先驅者,Movano Health今天宣佈其EvieMED Ring中脈搏血氧儀獲得了美國食品和藥物管理局(FDA)的510(k)清除。 這一清除使Movano Health能夠追求價值數十億美元的業務機會,爲醫療保健提供監視解決方案,例如臨床試驗、後臨床試驗管理以及醫療保健提供者和支付方所需的遠程患者監控。

"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."

"我們在消費市場推出了Evie Ring,但我們更廣泛的目標一直是爲B20億渠道提供臨床級設備," Movano Health總裁兼首席執行官約翰·馬斯特羅泰羅說。"這項FDA 510(k)清除標誌着公司的一個重要里程碑,並擴大了我們對藥品公司、醫療器械製造商和尋找更準確、一致和舒適的健康監測解決方案以幫助通過方便地融入患者生活方式提高遵從性的支付方的接觸面。"

Movano Health Receives FDA Clearance for EvieMED Ring

Movano Health獲得FDA批准,推出EvieMED戒指

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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.

與預期的510(k)清除相配合,Movano Health一直與跨越整個醫療行業光譜的許多潛在合作伙伴合作,並預計其合作伙伴管道在獲得清除消息後將進一步擴大。 該公司目前正在與一家大型支付方就計劃於2025年初早期使用EvieMED Ring進行與高風險人群的健康管理相關的試點研究進行協議階段,並且正在與一家全球藥品公司和領先的臨床研究組織(CRO)就在即將進行的臨床試驗中使用EvieMED Ring展開討論。 此外,EvieMED Ring最近被選定用於關於長期COVID和慢性萊姆病的開創性MIT研究。

"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."

這個里程碑標誌着我們加速推廣 EvieMED 計劃的開始。通過完成首次獲批的重要基礎工作,我們渴望繼續與 FDA 合作,以獲取額外的審批,包括呼吸速率和其他關鍵的分析物和診斷。Mastrototaro 繼續表示:「我們也對利用我們專有的射頻(RF)技術來解決無袖血壓監測和非侵入式血糖監測的機會感到興奮。」

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.

脈搏血氧計可以測量血氧(SpO2)水平和心率,但傳統解決方案存在重大缺陷,可能會造成不適,這可能會影響患者需要確保可靠信息以評估其健康狀況的遵從性。EvieMED 戒指通過將醫療器械的準確性與連續佩戴的舒適性相結合,消除了這些限制,部分得益於其獲獎設計,具有戒指表面的小縫隙和輕微彎曲,適應了手指腫脹。一項關鍵研究還發現,EvieMED 戒指可以準確測量 Fitzpatrick 膚色分類標準中皮膚顏色較深用戶的讀數。

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.

此外,EvieMED 戒指還收集健康指標,包括睡眠、活動、溫度變化、燃燒的熱量和呼吸速率,這可以爲患者和醫療保健提供者提供用戶整體健康狀況更廣泛的圖片。

The EvieMED Ring will be available in eight sizes ranging from 5 to 12 to accommodate the widest selection of patients.

EvieMED 戒指將提供八種尺寸,範圍從 5 到 12,以適應最廣泛的患者選擇。

About Movano Health

Movano Health公司簡介:成立於2018年,Movano Inc.(Nasdaq:MOVE)是正在開發一系列有目的的醫療保健解決方案,來將醫療級別數據引入到可穿戴設備的最前沿。Movano Health的設備具有現代和靈活的外形,兼備了準確度和受用性,爲客戶和企業提供了一種創新的方法,捕捉個人的健康數據全面畫像,並將其翻譯成個性化和智能化的見解。

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.

成立於 2018 年,Movano 公司 (納斯達克:MOVE)運營名稱爲 Movano Health,正在開發一套以目的驅動的醫療保健解決方案,將醫療級別數據置於可穿戴設備的前沿。Movano Health 的設備採用現代和靈活的外形,提供一種創新的方法,將可信賴的數據傳遞給客戶和企業,捕獲個體健康數據的全面畫面,並獨特地將其轉化爲個性化和智能洞察。

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 .

Movano Health的專有技術和可穿戴醫療器械解決方案將很快使數據成爲一種工具,用於主動監測和管理醫療保健中存在的多個患者群體的健康結果。有關Movano Health的更多信息,請訪問。

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.

前瞻性聲明
本新聞稿包含關於我們對未來的期望、預期、意圖、信念或策略的前瞻性聲明。這些前瞻性聲明是基於我們在此日期所作的假設,並且受到已知和未知的風險和不確定性的影響,這些風險和不確定性可能導致實際結果、情況和事件與預期不符。因此,您不應過度依賴前瞻性聲明。前瞻性聲明的示例包括但不限於我們對Evie Ring和EvieMED商業推出計劃的聲明;我們對潛在商業機會的預期;計劃削減成本的措施;預期FDA對我們產品的清關決定;預期的未來運營結果;產品開發和特性、產品發佈、臨床試驗和監管舉措;我們的戰略、定位和對未來事件或績效的期望。導致實際結果與前瞻性聲明不符的重要因素在我們最近的年度報告Form 10-k,以及後續的季度報告Form 10-Q和其他提交給證券交易委員會的報告中都有詳細闡述,其中包括「風險因素」標題下的內容。本公告中的任何前瞻性聲明僅當日發佈時有效。我們不承諾公開更新任何前瞻性聲明,無論是書面還是口頭,無論是出於新信息、未來發展或其他原因。

SOURCE Movano

來源:Movano

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