{"id":35398,"date":"2025-08-05T22:32:28","date_gmt":"2025-08-05T22:32:28","guid":{"rendered":"https:\/\/allonlinebanglanewspapers.com\/news\/respiree-secures-second-fda-510k-clearance-expands-cardio-respiratory-wearable-to-home-use-via-1bio-connected-care-platform\/"},"modified":"2025-08-05T22:32:28","modified_gmt":"2025-08-05T22:32:28","slug":"respiree-secures-second-fda-510k-clearance-expands-cardio-respiratory-wearable-to-home-use-via-1bio-connected-care-platform","status":"publish","type":"post","link":"https:\/\/allonlinebanglanewspapers.com\/news\/respiree-secures-second-fda-510k-clearance-expands-cardio-respiratory-wearable-to-home-use-via-1bio-connected-care-platform\/","title":{"rendered":"Respiree Secures Second FDA 510(k) Clearance, Expands Cardio-Respiratory Wearable to Home Use via 1Bio\u2122 Connected Care Platform"},"content":{"rendered":"
\n

HOUSTON and SINGAPORE, Aug. 05, 2025 (GLOBE NEWSWIRE) — Respiree, a health tech company developing artificial intelligence (AI) platforms to manage disease progression across the healthcare continuum,\u00a0today announced it has received its second U.S. Food and Drug Administration (FDA) 510(k) clearance. The clearance expands the use of its RS001 cardio-respiratory wearable to home environments and includes approval for its connected care platform marketed as 1Bio\u2122<\/strong>.<\/p>\n

<\/p>\n

Illustrative Image of Respiree\u2019s RS001 Wearable With its Connected Care 1Bio\u2122 Platform<\/em><\/p>\n

The\u00a0RS001<\/strong>\u00a0is a chest-worn device that directly measures respiration and offers passive cardio-respiratory monitoring. Originally cleared for in-patient clinical use, the RS001\u2019s use in home settings marks a significant step toward more accessible and preventive healthcare. The device connects to a\u00a0cellular hub<\/strong>, which enables data to be visualized in real time via the\u00a0connected care<\/strong>\u00a01Bio\u2122 dashboard.<\/p>\n

\u201cRespiration is the most predictive vital sign for clinical deterioration, yet it remains underutilized \u2013 particularly outside hospital settings,\u201d said\u00a0Dr. Gurpreet Singh<\/strong>, CEO and Founder of Respiree. \u201cThis FDA 510(k) extension allows healthcare systems to passively and accurately monitor leading indicators in the home, enabling earlier interventions and reducing the overall burden on healthcare infrastructure.\u201d<\/p>\n

The announcement follows Respiree\u2019s recent\u00a0US$11.6 million Series A financing round<\/strong>, led by\u00a0We Venture Capital <\/strong>and\u00a0ClavystBio<\/strong>, which will accelerate development toward potential regulatory approvals and global market expansion. Respiree also announced plans to pursue additional FDA clearances for its proprietary\u00a0AI software<\/strong>, aiming to integrate artificial intelligence models into the 1Bio\u2122 platform for both inpatient and home-based care.<\/p>\n

\u201cThese are exciting times for us,\u201d added Dr. Singh. \u201cOur first 510(k) was for the wearable; this second one is for the platform. We are now focused on bringing our flagship AI models into the fold as a Software as a Medical Device (SaMD).\u201d<\/p>\n

About Respiree<\/strong><\/p>\n

Respiree\u2122 is an AI\/ML health tech company building state-of-the-art clinically-validated artificial intelligence (AI) for managing disease progression across healthcare\u2019s care continuum. The 1Bio\u2122 platform by Respiree\u2122 uses data from the EHR and its proprietary US-patented and FDA-cleared sensors to longitudinal measure and track disease progression. Respiree\u2122 is now available in U.S., Australia and Asia-Pacific (APAC). Respiree\u2122 is CE marked, has received regulatory clearances in Australia from the Therapeutics Goods Administration and has received the 510k clearance from the United States Food and Drug Administration (FDA). (www.respiree.com<\/a>)<\/p>\n

Media Enquiries<\/strong><\/p>\n

Evangeline Fu<\/em>
Administrative Manager<\/em>
Respiree Pte Ltd<\/em>
Email:\u00a0<\/em>evangeline@respiree.com<\/a><\/em><\/p>\n

A photo accompanying this announcement is available at https:\/\/www.globenewswire.com\/NewsRoom\/AttachmentNg\/aea7197c-89ac-4dbb-82b9-da85e7dd07f8<\/a><\/p>\n

\"\"\n <\/div>\n","protected":false},"excerpt":{"rendered":"

HOUSTON and SINGAPORE, Aug. 05, 2025 (GLOBE NEWSWIRE) — Respiree, a health tech company developing artificial intelligence (AI) platforms to manage disease progression across the healthcare continuum,\u00a0today announced it has received its second U.S. Food and Drug Administration (FDA) 510(k) clearance. The clearance expands the use of its RS001 cardio-respiratory wearable to home environments and […]<\/p>\n","protected":false},"author":2,"featured_media":35399,"comment_status":"","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"fifu_image_url":"https:\/\/ml.globenewswire.com\/Resource\/Download\/5f70ba57-dae6-45e2-a400-a5d78b078210","fifu_image_alt":"","footnotes":""},"categories":[11],"tags":[],"class_list":["post-35398","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-globenewswire"],"acf":[],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/allonlinebanglanewspapers.com\/news\/wp-json\/wp\/v2\/posts\/35398","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/allonlinebanglanewspapers.com\/news\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/allonlinebanglanewspapers.com\/news\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/allonlinebanglanewspapers.com\/news\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/allonlinebanglanewspapers.com\/news\/wp-json\/wp\/v2\/comments?post=35398"}],"version-history":[{"count":0,"href":"https:\/\/allonlinebanglanewspapers.com\/news\/wp-json\/wp\/v2\/posts\/35398\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/allonlinebanglanewspapers.com\/news\/wp-json\/wp\/v2\/media\/35399"}],"wp:attachment":[{"href":"https:\/\/allonlinebanglanewspapers.com\/news\/wp-json\/wp\/v2\/media?parent=35398"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/allonlinebanglanewspapers.com\/news\/wp-json\/wp\/v2\/categories?post=35398"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/allonlinebanglanewspapers.com\/news\/wp-json\/wp\/v2\/tags?post=35398"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}