http://www.streetinsider.com Latest StreetInsider.com News Articles en-us Copyright 2026, StreetInsider.com rss@streetinsider.com (SI RSS) rss@streetinsider.com (SI RSS) Mon, 13 Apr 2026 06:02:38 -0400 http://blogs.law.harvard.edu/tech/rss http://www.streetinsider.com/images/rss_logo.gif http://www.streetinsider.com 143 28 0 1 2 3 21 22 23 Saturday Sunday http://www.streetinsider.com/SPAC/ProSomnus+receives+FDA+clearance+for+sleep+apnea+monitoring+device/26302141.html <p>ProSomnus Sleep Technologies announced that the U.S. Food and Drug Administration has granted Class II 510(k) clearance for its RPMO₂ OSA Device under FDA K252765. The device combines oral appliance therapy with physiologic monitoring for obstructive sleep apnea treatment.</p><p>The RPMO₂ OSA Device measures oxygen saturation and pulse rate through an embedded oximeter that uses buccal mucosa behind the upper lip as the reflective tissue. Data transmits to a provider portal via a smartphone application.</p><p>FDA clearance was supported by a validation study conducted at the University of Calgary and published by Snow et al. in 2025. The study enrolled 12 healthy http://www.streetinsider.com/SPAC/ProSomnus+receives+FDA+clearance+for+sleep+apnea+monitoring+device/26302141.html Mon, 13 Apr 2026 06:02:38 -0400 LAAA OSAP OSAPQ http://www.streetinsider.com/SPAC/ProSomnus+receives+FDA+clearance+for+sleep+apnea+monitoring+device/26302141.html <p>ProSomnus Sleep Technologies announced that the U.S. Food and Drug Administration has granted Class II 510(k) clearance for its RPMO₂ OSA Device under FDA K252765. The device combines oral appliance therapy with physiologic monitoring for obstructive sleep apnea treatment.</p><p>The RPMO₂ OSA Device measures oxygen saturation and pulse rate through an embedded oximeter that uses buccal mucosa behind the upper lip as the reflective tissue. Data transmits to a provider portal via a smartphone application.</p><p>FDA clearance was supported by a validation study conducted at the University of Calgary and published by Snow et al. in 2025. The study enrolled 12 healthy http://www.streetinsider.com/SPAC/ProSomnus+receives+FDA+clearance+for+sleep+apnea+monitoring+device/26302141.html Mon, 13 Apr 2026 06:02:38 -0400 LAAA OSAP OSAPQ http://www.streetinsider.com/SPAC/ProSomnus+receives+FDA+clearance+for+sleep+apnea+monitoring+device/26302141.html <p>ProSomnus Sleep Technologies announced that the U.S. Food and Drug Administration has granted Class II 510(k) clearance for its RPMO₂ OSA Device under FDA K252765. The device combines oral appliance therapy with physiologic monitoring for obstructive sleep apnea treatment.</p><p>The RPMO₂ OSA Device measures oxygen saturation and pulse rate through an embedded oximeter that uses buccal mucosa behind the upper lip as the reflective tissue. Data transmits to a provider portal via a smartphone application.</p><p>FDA clearance was supported by a validation study conducted at the University of Calgary and published by Snow et al. in 2025. The study enrolled 12 healthy http://www.streetinsider.com/SPAC/ProSomnus+receives+FDA+clearance+for+sleep+apnea+monitoring+device/26302141.html Mon, 13 Apr 2026 06:02:38 -0400 LAAA OSAP OSAPQ http://www.streetinsider.com/Corporate+News/ProSomnus+receives+FDA+clearance+for+sleep+apnea+monitoring+device/26302141.html <p>ProSomnus Sleep Technologies announced that the U.S. Food and Drug Administration has granted Class II 510(k) clearance for its RPMO₂ OSA Device under FDA K252765. The device combines oral appliance therapy with physiologic monitoring for obstructive sleep apnea treatment.</p><p>The RPMO₂ OSA Device measures oxygen saturation and pulse rate through an embedded oximeter that uses buccal mucosa behind the upper lip as the reflective tissue. Data transmits to a provider portal via a smartphone application.</p><p>FDA clearance was supported by a validation study conducted at the University of Calgary and published by Snow et al. in 2025. The study enrolled 12 healthy http://www.streetinsider.com/Corporate+News/ProSomnus+receives+FDA+clearance+for+sleep+apnea+monitoring+device/26302141.html Mon, 13 Apr 2026 06:02:38 -0400 LAAA OSAP OSAPQ http://www.streetinsider.com/Corporate+News/ProSomnus+receives+FDA+clearance+for+sleep+apnea+monitoring+device/26302141.html <p>ProSomnus Sleep Technologies announced that the U.S. Food and Drug Administration has granted Class II 510(k) clearance for its RPMO₂ OSA Device under FDA K252765. The device combines oral appliance therapy with physiologic monitoring for obstructive sleep apnea treatment.</p><p>The RPMO₂ OSA Device measures oxygen saturation and pulse rate through an embedded oximeter that uses buccal mucosa behind the upper lip as the reflective tissue. Data transmits to a provider portal via a smartphone application.</p><p>FDA clearance was supported by a validation study conducted at the University of Calgary and published by Snow et al. in 2025. The study enrolled 12 healthy http://www.streetinsider.com/Corporate+News/ProSomnus+receives+FDA+clearance+for+sleep+apnea+monitoring+device/26302141.html Mon, 13 Apr 2026 06:02:38 -0400 LAAA OSAP OSAPQ http://www.streetinsider.com/Corporate+News/ProSomnus+receives+FDA+clearance+for+sleep+apnea+monitoring+device/26302141.html <p>ProSomnus Sleep Technologies announced that the U.S. Food and Drug Administration has granted Class II 510(k) clearance for its RPMO₂ OSA Device under FDA K252765. The device combines oral appliance therapy with physiologic monitoring for obstructive sleep apnea treatment.</p><p>The RPMO₂ OSA Device measures oxygen saturation and pulse rate through an embedded oximeter that uses buccal mucosa behind the upper lip as the reflective tissue. Data transmits to a provider portal via a smartphone application.</p><p>FDA clearance was supported by a validation study conducted at the University of Calgary and published by Snow et al. in 2025. The study enrolled 12 healthy http://www.streetinsider.com/Corporate+News/ProSomnus+receives+FDA+clearance+for+sleep+apnea+monitoring+device/26302141.html Mon, 13 Apr 2026 06:02:38 -0400 LAAA OSAP OSAPQ http://www.streetinsider.com/Press+Releases/ProSomnus%C2%AE+Receives+FDA+Class+II+Clearance+for+RPMO2+OSA+Device/26301985.html <p>SAN FRANCISCO, April 13, 2026 (GLOBE NEWSWIRE) -- ProSomnus Sleep Technologies (“the Company”), the leading non-CPAP Obstructive Sleep Apnea (OSA) therapy® and pioneer in Smart Sleep Medicine™, today announced that the U.S. Food and Drug Administration (FDA) has granted Class II 510(k) clearance for its RPMO₂ OSA Device under the product codes DQA, LQZ, LRK, PLC, and OUG (FDA K252765). The RPMO2 OSA Device is the first theragnostic device for sleep medicine, incorporating both precision oral appliance therapy and multi-night physiologic monitoring in one device.</p> <p>This clearance affirms that the ProSomnus RPMO₂ OSA Device meets the FDA’s http://www.streetinsider.com/Press+Releases/ProSomnus%C2%AE+Receives+FDA+Class+II+Clearance+for+RPMO2+OSA+Device/26301985.html Mon, 13 Apr 2026 06:00:00 -0400 A.06822034 A.13527880 A.50205227 LAAA O.00403523 O.20026344 O.22219859 O.54177151 OSAP OSAPQ http://www.streetinsider.com/Press+Releases/ProSomnus%C2%AE+Receives+FDA+Class+II+Clearance+for+RPMO2+OSA+Device/26301985.html <p>SAN FRANCISCO, April 13, 2026 (GLOBE NEWSWIRE) -- ProSomnus Sleep Technologies (“the Company”), the leading non-CPAP Obstructive Sleep Apnea (OSA) therapy® and pioneer in Smart Sleep Medicine™, today announced that the U.S. Food and Drug Administration (FDA) has granted Class II 510(k) clearance for its RPMO₂ OSA Device under the product codes DQA, LQZ, LRK, PLC, and OUG (FDA K252765). The RPMO2 OSA Device is the first theragnostic device for sleep medicine, incorporating both precision oral appliance therapy and multi-night physiologic monitoring in one device.</p> <p>This clearance affirms that the ProSomnus RPMO₂ OSA Device meets the FDA’s http://www.streetinsider.com/Press+Releases/ProSomnus%C2%AE+Receives+FDA+Class+II+Clearance+for+RPMO2+OSA+Device/26301985.html Mon, 13 Apr 2026 06:00:00 -0400 A.06822034 A.13527880 A.50205227 LAAA O.00403523 O.20026344 O.22219859 O.54177151 OSAP OSAPQ http://www.streetinsider.com/Press+Releases/ProSomnus%C2%AE+Receives+FDA+Class+II+Clearance+for+RPMO2+OSA+Device/26301985.html <p>SAN FRANCISCO, April 13, 2026 (GLOBE NEWSWIRE) -- ProSomnus Sleep Technologies (“the Company”), the leading non-CPAP Obstructive Sleep Apnea (OSA) therapy® and pioneer in Smart Sleep Medicine™, today announced that the U.S. Food and Drug Administration (FDA) has granted Class II 510(k) clearance for its RPMO₂ OSA Device under the product codes DQA, LQZ, LRK, PLC, and OUG (FDA K252765). The RPMO2 OSA Device is the first theragnostic device for sleep medicine, incorporating both precision oral appliance therapy and multi-night physiologic monitoring in one device.</p> <p>This clearance affirms that the ProSomnus RPMO₂ OSA Device meets the FDA’s http://www.streetinsider.com/Press+Releases/ProSomnus%C2%AE+Receives+FDA+Class+II+Clearance+for+RPMO2+OSA+Device/26301985.html Mon, 13 Apr 2026 06:00:00 -0400 A.06822034 A.13527880 A.50205227 LAAA O.00403523 O.20026344 O.22219859 O.54177151 OSAP OSAPQ http://www.streetinsider.com/Press+Releases/ProSomnus%C2%AE+Receives+FDA+Class+II+Clearance+for+RPMO2+OSA+Device/26301985.html <p>SAN FRANCISCO, April 13, 2026 (GLOBE NEWSWIRE) -- ProSomnus Sleep Technologies (“the Company”), the leading non-CPAP Obstructive Sleep Apnea (OSA) therapy® and pioneer in Smart Sleep Medicine™, today announced that the U.S. Food and Drug Administration (FDA) has granted Class II 510(k) clearance for its RPMO₂ OSA Device under the product codes DQA, LQZ, LRK, PLC, and OUG (FDA K252765). The RPMO2 OSA Device is the first theragnostic device for sleep medicine, incorporating both precision oral appliance therapy and multi-night physiologic monitoring in one device.</p> <p>This clearance affirms that the ProSomnus RPMO₂ OSA Device meets the FDA’s http://www.streetinsider.com/Press+Releases/ProSomnus%C2%AE+Receives+FDA+Class+II+Clearance+for+RPMO2+OSA+Device/26301985.html Mon, 13 Apr 2026 06:00:00 -0400 A.06822034 A.13527880 A.50205227 LAAA O.00403523 O.20026344 O.22219859 O.54177151 OSAP OSAPQ http://www.streetinsider.com/Press+Releases/ProSomnus%C2%AE+Receives+FDA+Class+II+Clearance+for+RPMO2+OSA+Device/26301985.html <p>SAN FRANCISCO, April 13, 2026 (GLOBE NEWSWIRE) -- ProSomnus Sleep Technologies (“the Company”), the leading non-CPAP Obstructive Sleep Apnea (OSA) therapy® and pioneer in Smart Sleep Medicine™, today announced that the U.S. Food and Drug Administration (FDA) has granted Class II 510(k) clearance for its RPMO₂ OSA Device under the product codes DQA, LQZ, LRK, PLC, and OUG (FDA K252765). The RPMO2 OSA Device is the first theragnostic device for sleep medicine, incorporating both precision oral appliance therapy and multi-night physiologic monitoring in one device.</p> <p>This clearance affirms that the ProSomnus RPMO₂ OSA Device meets the FDA’s http://www.streetinsider.com/Press+Releases/ProSomnus%C2%AE+Receives+FDA+Class+II+Clearance+for+RPMO2+OSA+Device/26301985.html Mon, 13 Apr 2026 06:00:00 -0400 A.06822034 A.13527880 A.50205227 LAAA O.00403523 O.20026344 O.22219859 O.54177151 OSAP OSAPQ http://www.streetinsider.com/Press+Releases/ProSomnus%C2%AE+Receives+FDA+Class+II+Clearance+for+RPMO2+OSA+Device/26301985.html <p>SAN FRANCISCO, April 13, 2026 (GLOBE NEWSWIRE) -- ProSomnus Sleep Technologies (“the Company”), the leading non-CPAP Obstructive Sleep Apnea (OSA) therapy® and pioneer in Smart Sleep Medicine™, today announced that the U.S. Food and Drug Administration (FDA) has granted Class II 510(k) clearance for its RPMO₂ OSA Device under the product codes DQA, LQZ, LRK, PLC, and OUG (FDA K252765). The RPMO2 OSA Device is the first theragnostic device for sleep medicine, incorporating both precision oral appliance therapy and multi-night physiologic monitoring in one device.</p> <p>This clearance affirms that the ProSomnus RPMO₂ OSA Device meets the FDA’s http://www.streetinsider.com/Press+Releases/ProSomnus%C2%AE+Receives+FDA+Class+II+Clearance+for+RPMO2+OSA+Device/26301985.html Mon, 13 Apr 2026 06:00:00 -0400 A.06822034 A.13527880 A.50205227 LAAA O.00403523 O.20026344 O.22219859 O.54177151 OSAP OSAPQ http://www.streetinsider.com/Press+Releases/ProSomnus%C2%AE+Receives+FDA+Class+II+Clearance+for+RPMO2+OSA+Device/26301985.html <p>SAN FRANCISCO, April 13, 2026 (GLOBE NEWSWIRE) -- ProSomnus Sleep Technologies (“the Company”), the leading non-CPAP Obstructive Sleep Apnea (OSA) therapy® and pioneer in Smart Sleep Medicine™, today announced that the U.S. Food and Drug Administration (FDA) has granted Class II 510(k) clearance for its RPMO₂ OSA Device under the product codes DQA, LQZ, LRK, PLC, and OUG (FDA K252765). The RPMO2 OSA Device is the first theragnostic device for sleep medicine, incorporating both precision oral appliance therapy and multi-night physiologic monitoring in one device.</p> <p>This clearance affirms that the ProSomnus RPMO₂ OSA Device meets the FDA’s http://www.streetinsider.com/Press+Releases/ProSomnus%C2%AE+Receives+FDA+Class+II+Clearance+for+RPMO2+OSA+Device/26301985.html Mon, 13 Apr 2026 06:00:00 -0400 A.06822034 A.13527880 A.50205227 LAAA O.00403523 O.20026344 O.22219859 O.54177151 OSAP OSAPQ http://www.streetinsider.com/Press+Releases/ProSomnus%C2%AE+Receives+FDA+Class+II+Clearance+for+RPMO2+OSA+Device/26301985.html <p>SAN FRANCISCO, April 13, 2026 (GLOBE NEWSWIRE) -- ProSomnus Sleep Technologies (“the Company”), the leading non-CPAP Obstructive Sleep Apnea (OSA) therapy® and pioneer in Smart Sleep Medicine™, today announced that the U.S. Food and Drug Administration (FDA) has granted Class II 510(k) clearance for its RPMO₂ OSA Device under the product codes DQA, LQZ, LRK, PLC, and OUG (FDA K252765). The RPMO2 OSA Device is the first theragnostic device for sleep medicine, incorporating both precision oral appliance therapy and multi-night physiologic monitoring in one device.</p> <p>This clearance affirms that the ProSomnus RPMO₂ OSA Device meets the FDA’s http://www.streetinsider.com/Press+Releases/ProSomnus%C2%AE+Receives+FDA+Class+II+Clearance+for+RPMO2+OSA+Device/26301985.html Mon, 13 Apr 2026 06:00:00 -0400 A.06822034 A.13527880 A.50205227 LAAA O.00403523 O.20026344 O.22219859 O.54177151 OSAP OSAPQ http://www.streetinsider.com/Press+Releases/ProSomnus%C2%AE+Receives+FDA+Class+II+Clearance+for+RPMO2+OSA+Device/26301985.html <p>SAN FRANCISCO, April 13, 2026 (GLOBE NEWSWIRE) -- ProSomnus Sleep Technologies (“the Company”), the leading non-CPAP Obstructive Sleep Apnea (OSA) therapy® and pioneer in Smart Sleep Medicine™, today announced that the U.S. Food and Drug Administration (FDA) has granted Class II 510(k) clearance for its RPMO₂ OSA Device under the product codes DQA, LQZ, LRK, PLC, and OUG (FDA K252765). The RPMO2 OSA Device is the first theragnostic device for sleep medicine, incorporating both precision oral appliance therapy and multi-night physiologic monitoring in one device.</p> <p>This clearance affirms that the ProSomnus RPMO₂ OSA Device meets the FDA’s http://www.streetinsider.com/Press+Releases/ProSomnus%C2%AE+Receives+FDA+Class+II+Clearance+for+RPMO2+OSA+Device/26301985.html Mon, 13 Apr 2026 06:00:00 -0400 A.06822034 A.13527880 A.50205227 LAAA O.00403523 O.20026344 O.22219859 O.54177151 OSAP OSAPQ http://www.streetinsider.com/Press+Releases/ProSomnus%C2%AE+Receives+FDA+Class+II+Clearance+for+RPMO2+OSA+Device/26301985.html <p>SAN FRANCISCO, April 13, 2026 (GLOBE NEWSWIRE) -- ProSomnus Sleep Technologies (“the Company”), the leading non-CPAP Obstructive Sleep Apnea (OSA) therapy® and pioneer in Smart Sleep Medicine™, today announced that the U.S. Food and Drug Administration (FDA) has granted Class II 510(k) clearance for its RPMO₂ OSA Device under the product codes DQA, LQZ, LRK, PLC, and OUG (FDA K252765). The RPMO2 OSA Device is the first theragnostic device for sleep medicine, incorporating both precision oral appliance therapy and multi-night physiologic monitoring in one device.</p> <p>This clearance affirms that the ProSomnus RPMO₂ OSA Device meets the FDA’s http://www.streetinsider.com/Press+Releases/ProSomnus%C2%AE+Receives+FDA+Class+II+Clearance+for+RPMO2+OSA+Device/26301985.html Mon, 13 Apr 2026 06:00:00 -0400 A.06822034 A.13527880 A.50205227 LAAA O.00403523 O.20026344 O.22219859 O.54177151 OSAP OSAPQ http://www.streetinsider.com/Globe+Newswire/ProSomnus%C2%AE+Receives+FDA+Class+II+Clearance+for+RPMO2+OSA+Device/26301985.html <p>SAN FRANCISCO, April 13, 2026 (GLOBE NEWSWIRE) -- ProSomnus Sleep Technologies (“the Company”), the leading non-CPAP Obstructive Sleep Apnea (OSA) therapy® and pioneer in Smart Sleep Medicine™, today announced that the U.S. Food and Drug Administration (FDA) has granted Class II 510(k) clearance for its RPMO₂ OSA Device under the product codes DQA, LQZ, LRK, PLC, and OUG (FDA K252765). The RPMO2 OSA Device is the first theragnostic device for sleep medicine, incorporating both precision oral appliance therapy and multi-night physiologic monitoring in one device.</p> <p>This clearance affirms that the ProSomnus RPMO₂ OSA Device meets the FDA’s http://www.streetinsider.com/Globe+Newswire/ProSomnus%C2%AE+Receives+FDA+Class+II+Clearance+for+RPMO2+OSA+Device/26301985.html Mon, 13 Apr 2026 06:00:00 -0400 A.06822034 A.13527880 A.50205227 LAAA O.00403523 O.20026344 O.22219859 O.54177151 OSAP OSAPQ http://www.streetinsider.com/Globe+Newswire/ProSomnus%C2%AE+Receives+FDA+Class+II+Clearance+for+RPMO2+OSA+Device/26301985.html <p>SAN FRANCISCO, April 13, 2026 (GLOBE NEWSWIRE) -- ProSomnus Sleep Technologies (“the Company”), the leading non-CPAP Obstructive Sleep Apnea (OSA) therapy® and pioneer in Smart Sleep Medicine™, today announced that the U.S. Food and Drug Administration (FDA) has granted Class II 510(k) clearance for its RPMO₂ OSA Device under the product codes DQA, LQZ, LRK, PLC, and OUG (FDA K252765). The RPMO2 OSA Device is the first theragnostic device for sleep medicine, incorporating both precision oral appliance therapy and multi-night physiologic monitoring in one device.</p> <p>This clearance affirms that the ProSomnus RPMO₂ OSA Device meets the FDA’s http://www.streetinsider.com/Globe+Newswire/ProSomnus%C2%AE+Receives+FDA+Class+II+Clearance+for+RPMO2+OSA+Device/26301985.html Mon, 13 Apr 2026 06:00:00 -0400 A.06822034 A.13527880 A.50205227 LAAA O.00403523 O.20026344 O.22219859 O.54177151 OSAP OSAPQ http://www.streetinsider.com/Globe+Newswire/ProSomnus%C2%AE+Receives+FDA+Class+II+Clearance+for+RPMO2+OSA+Device/26301985.html <p>SAN FRANCISCO, April 13, 2026 (GLOBE NEWSWIRE) -- ProSomnus Sleep Technologies (“the Company”), the leading non-CPAP Obstructive Sleep Apnea (OSA) therapy® and pioneer in Smart Sleep Medicine™, today announced that the U.S. Food and Drug Administration (FDA) has granted Class II 510(k) clearance for its RPMO₂ OSA Device under the product codes DQA, LQZ, LRK, PLC, and OUG (FDA K252765). The RPMO2 OSA Device is the first theragnostic device for sleep medicine, incorporating both precision oral appliance therapy and multi-night physiologic monitoring in one device.</p> <p>This clearance affirms that the ProSomnus RPMO₂ OSA Device meets the FDA’s http://www.streetinsider.com/Globe+Newswire/ProSomnus%C2%AE+Receives+FDA+Class+II+Clearance+for+RPMO2+OSA+Device/26301985.html Mon, 13 Apr 2026 06:00:00 -0400 A.06822034 A.13527880 A.50205227 LAAA O.00403523 O.20026344 O.22219859 O.54177151 OSAP OSAPQ http://www.streetinsider.com/Globe+Newswire/ProSomnus%C2%AE+Receives+FDA+Class+II+Clearance+for+RPMO2+OSA+Device/26301985.html <p>SAN FRANCISCO, April 13, 2026 (GLOBE NEWSWIRE) -- ProSomnus Sleep Technologies (“the Company”), the leading non-CPAP Obstructive Sleep Apnea (OSA) therapy® and pioneer in Smart Sleep Medicine™, today announced that the U.S. Food and Drug Administration (FDA) has granted Class II 510(k) clearance for its RPMO₂ OSA Device under the product codes DQA, LQZ, LRK, PLC, and OUG (FDA K252765). The RPMO2 OSA Device is the first theragnostic device for sleep medicine, incorporating both precision oral appliance therapy and multi-night physiologic monitoring in one device.</p> <p>This clearance affirms that the ProSomnus RPMO₂ OSA Device meets the FDA’s http://www.streetinsider.com/Globe+Newswire/ProSomnus%C2%AE+Receives+FDA+Class+II+Clearance+for+RPMO2+OSA+Device/26301985.html Mon, 13 Apr 2026 06:00:00 -0400 A.06822034 A.13527880 A.50205227 LAAA O.00403523 O.20026344 O.22219859 O.54177151 OSAP OSAPQ http://www.streetinsider.com/Globe+Newswire/ProSomnus%C2%AE+Receives+FDA+Class+II+Clearance+for+RPMO2+OSA+Device/26301985.html <p>SAN FRANCISCO, April 13, 2026 (GLOBE NEWSWIRE) -- ProSomnus Sleep Technologies (“the Company”), the leading non-CPAP Obstructive Sleep Apnea (OSA) therapy® and pioneer in Smart Sleep Medicine™, today announced that the U.S. Food and Drug Administration (FDA) has granted Class II 510(k) clearance for its RPMO₂ OSA Device under the product codes DQA, LQZ, LRK, PLC, and OUG (FDA K252765). The RPMO2 OSA Device is the first theragnostic device for sleep medicine, incorporating both precision oral appliance therapy and multi-night physiologic monitoring in one device.</p> <p>This clearance affirms that the ProSomnus RPMO₂ OSA Device meets the FDA’s http://www.streetinsider.com/Globe+Newswire/ProSomnus%C2%AE+Receives+FDA+Class+II+Clearance+for+RPMO2+OSA+Device/26301985.html Mon, 13 Apr 2026 06:00:00 -0400 A.06822034 A.13527880 A.50205227 LAAA O.00403523 O.20026344 O.22219859 O.54177151 OSAP OSAPQ http://www.streetinsider.com/Globe+Newswire/ProSomnus%C2%AE+Receives+FDA+Class+II+Clearance+for+RPMO2+OSA+Device/26301985.html <p>SAN FRANCISCO, April 13, 2026 (GLOBE NEWSWIRE) -- ProSomnus Sleep Technologies (“the Company”), the leading non-CPAP Obstructive Sleep Apnea (OSA) therapy® and pioneer in Smart Sleep Medicine™, today announced that the U.S. Food and Drug Administration (FDA) has granted Class II 510(k) clearance for its RPMO₂ OSA Device under the product codes DQA, LQZ, LRK, PLC, and OUG (FDA K252765). The RPMO2 OSA Device is the first theragnostic device for sleep medicine, incorporating both precision oral appliance therapy and multi-night physiologic monitoring in one device.</p> <p>This clearance affirms that the ProSomnus RPMO₂ OSA Device meets the FDA’s http://www.streetinsider.com/Globe+Newswire/ProSomnus%C2%AE+Receives+FDA+Class+II+Clearance+for+RPMO2+OSA+Device/26301985.html Mon, 13 Apr 2026 06:00:00 -0400 A.06822034 A.13527880 A.50205227 LAAA O.00403523 O.20026344 O.22219859 O.54177151 OSAP OSAPQ http://www.streetinsider.com/Globe+Newswire/ProSomnus%C2%AE+Receives+FDA+Class+II+Clearance+for+RPMO2+OSA+Device/26301985.html <p>SAN FRANCISCO, April 13, 2026 (GLOBE NEWSWIRE) -- ProSomnus Sleep Technologies (“the Company”), the leading non-CPAP Obstructive Sleep Apnea (OSA) therapy® and pioneer in Smart Sleep Medicine™, today announced that the U.S. Food and Drug Administration (FDA) has granted Class II 510(k) clearance for its RPMO₂ OSA Device under the product codes DQA, LQZ, LRK, PLC, and OUG (FDA K252765). The RPMO2 OSA Device is the first theragnostic device for sleep medicine, incorporating both precision oral appliance therapy and multi-night physiologic monitoring in one device.</p> <p>This clearance affirms that the ProSomnus RPMO₂ OSA Device meets the FDA’s http://www.streetinsider.com/Globe+Newswire/ProSomnus%C2%AE+Receives+FDA+Class+II+Clearance+for+RPMO2+OSA+Device/26301985.html Mon, 13 Apr 2026 06:00:00 -0400 A.06822034 A.13527880 A.50205227 LAAA O.00403523 O.20026344 O.22219859 O.54177151 OSAP OSAPQ http://www.streetinsider.com/Globe+Newswire/ProSomnus%C2%AE+Receives+FDA+Class+II+Clearance+for+RPMO2+OSA+Device/26301985.html <p>SAN FRANCISCO, April 13, 2026 (GLOBE NEWSWIRE) -- ProSomnus Sleep Technologies (“the Company”), the leading non-CPAP Obstructive Sleep Apnea (OSA) therapy® and pioneer in Smart Sleep Medicine™, today announced that the U.S. Food and Drug Administration (FDA) has granted Class II 510(k) clearance for its RPMO₂ OSA Device under the product codes DQA, LQZ, LRK, PLC, and OUG (FDA K252765). The RPMO2 OSA Device is the first theragnostic device for sleep medicine, incorporating both precision oral appliance therapy and multi-night physiologic monitoring in one device.</p> <p>This clearance affirms that the ProSomnus RPMO₂ OSA Device meets the FDA’s http://www.streetinsider.com/Globe+Newswire/ProSomnus%C2%AE+Receives+FDA+Class+II+Clearance+for+RPMO2+OSA+Device/26301985.html Mon, 13 Apr 2026 06:00:00 -0400 A.06822034 A.13527880 A.50205227 LAAA O.00403523 O.20026344 O.22219859 O.54177151 OSAP OSAPQ http://www.streetinsider.com/Globe+Newswire/ProSomnus%C2%AE+Receives+FDA+Class+II+Clearance+for+RPMO2+OSA+Device/26301985.html <p>SAN FRANCISCO, April 13, 2026 (GLOBE NEWSWIRE) -- ProSomnus Sleep Technologies (“the Company”), the leading non-CPAP Obstructive Sleep Apnea (OSA) therapy® and pioneer in Smart Sleep Medicine™, today announced that the U.S. Food and Drug Administration (FDA) has granted Class II 510(k) clearance for its RPMO₂ OSA Device under the product codes DQA, LQZ, LRK, PLC, and OUG (FDA K252765). The RPMO2 OSA Device is the first theragnostic device for sleep medicine, incorporating both precision oral appliance therapy and multi-night physiologic monitoring in one device.</p> <p>This clearance affirms that the ProSomnus RPMO₂ OSA Device meets the FDA’s http://www.streetinsider.com/Globe+Newswire/ProSomnus%C2%AE+Receives+FDA+Class+II+Clearance+for+RPMO2+OSA+Device/26301985.html Mon, 13 Apr 2026 06:00:00 -0400 A.06822034 A.13527880 A.50205227 LAAA O.00403523 O.20026344 O.22219859 O.54177151 OSAP OSAPQ