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energy natural resources environ ment heavy industry manufacturing telecomm unications lifestyle health consumer products retail entertain ment media health sports travel policy public interest people culture people culture send a release sign up log in resources rss gdpr send a release sign up log in resources rss gdpr send a release sign up log in resources rss gdpr fda approval the latest news regarding fda applications processes and approval this section contains releases regarding the food and drug administration s consideration of new products drugs therapies and treatments find announcements covering every stage of the fda application process from filing to eventual approval including appeals resubmissions and safety alerts jump to news releases 00 00 01 00 02 00 03 00 04 00 05 00 06 00 07 00 08 00 09 00 10 00 11 00 12 00 13 00 14 00 15 00 16 00 17 00 18 00 19 00 20 00 21 00 22 00 23 00 go making a selection with these dropdown will cause content on this page to change news listings will update as each option is selected items per page 25 per page 50 per page 75 per page 100 per page latest jun 03 2026 09 05 et vascuscreen introduces next generation wellness screening for healthcare providers vascuscreen a next generation health technology company operating at the intersection of preventive wellness and physiologic data today announced may 18 2026 10 00 et kreate medical announces two fda 510 k clearances introducing antibacterial absorbable synthetic matrix for wound management kreate medical a developer of advanced wound care technologies today announced that it has received two 510 k clearances from the us food and drug apr 02 2026 06 00 et prana surgical announces the prana system receives fda clearance prana surgical a houston based medical device company announced today that the u s food and drug administration fda has granted clearance for mar 27 2026 08 57 et spinepoint receives u s fda 510 k clearance for flex z cervical cage first product in the ultra low stiffness cushioning interbody platform spinepoint llc a medical device company developing low stiffness cushioning spinal interbody cages through advanced additive manufacturing jan 26 2026 10 15 et axolo health announces fda registration of new application of virtual reality therapy for phantom limb pain axolo health a surgeon founded medical software company today announced that its targeted brain rehabilitation tbr platform has been registered jan 16 2026 16 40 et fda clears heartlung s ai cvd enabling the broadest opportunistic cardiovascular multisystem ct screening platform heartlung corporation today announced u s food and drug administration fda clearance of ai cvd its flagship ai powered quantitative imaging dec 23 2025 18 00 et neosoma announces receiving fda 510 k clearance for brain mets neosoma inc is excited to announce that it has received fda 510 k clearance for its brain mets software medical device this clearance ushers in a dec 18 2025 14 00 et infinitt north america expands digital pathology portfolio with fda cleared hamamatsu s360md scanner integration the infinitt digital pathology solution fda cleared for primary diagnosis of ffpe tissue slides now supports hamamatsu ndpi file format through its dec 16 2025 09 30 et dendrite imaging announces fda clearance of nerve imaging surgical camera dendrite imaging inc the world leader in fluorescence guided surgical nerve imaging announced today its first product for intraoperative nerve nov 25 2025 16 35 et remington medical s vascuchek 2 0 bluetooth enabled cordless doppler receives fda clearance remington medical today announced u s food and drug administration fda 510 k clearance and the commercial launch of their second generation nov 15 2025 15 00 et maxx orthopedics announces fda 510 k clearance for libertas bipolar hip system maxx orthopedics inc norristown pa a rapidly expanding global orthopedics device company today announces that it has received us fda nov 15 2025 09 00 et maxx orthopedics announces fda 510 k clearance for freedom metaphyseal cone system maxx orthopedics inc norristown pa a rapidly expanding global orthopedics device company today announces that it received us fda clearance nov 13 2025 11 30 et captiva spine announces fda clearance for flat panel c arm calibrators and ai assisted registration for watchtower spine navigation advancing future ready access in an era when technology is rapidly reshaping spine surgery and contributing to the standard of care in spine navigation platforms still struggle nov 11 2025 11 00 et advancing hope for children with leukemia allterum therapeutics receives fda fast track designation for 4a10 in acute lymphoblastic leukemia allterum therapeutics a clinical stage biotechnology company committed to developing innovative best in class precision oncology and inflammation oct 24 2025 08 30 et resolute science receives fda orphan drug designation for its lead therapeutic rs 5 for soft tissue sarcomas resolute science inc a preclinical stage biotechnology company pioneering a novel class of pan cancer therapeutics for aggressive rare and oct 16 2025 16 30 et moonlight therapeutics receives fda clearance of ind application for moon101 and announces new funding moonlight therapeutics inc a biotechnology company developing a platform to treat food allergies today announced that the u s food and drug oct 09 2025 13 30 et hope in fight against pediatric cancers allterum therapeutics receives fda clearance of investigational new drug ind appl for 4a10 in acute lymphoblastic leukemia allterum therapeutics a clinical stage biotechnology company dedicated to developing innovative and best in class precision oncology and oct 06 2025 09 00 et tricelx inc announces fda registration of its cell manufacturing platform at the baylor scott white sports therapy and research center at the star in frisco texas tricelx inc tricelx a global translational leader in evidence based biologics announced fda registration of its iso level 7 fed 209e class sep 26 2025 17 26 et pda ansi standard on mycoplasma reduction filtration receives complete recognition status by u s fda cber the parenteral drug association pda is pleased to announce that pda ansi standard 05 2021 consensus method for rating filters for mycoplasma sep 24 2025 06 00 et spinal simplicity s intralink enrolled in fda s total product life cycle advisory program tap spinal simplicity a medical device company dedicated to creating simple innovative procedure solutions today announced that its intralink aug 21 2025 08 00 et venova medical receives fda ide approval for the venos 3 pivotal study of the velocity percutaneous avf system venova medical a privately held company developing a next generation technology for the creation of percutaneous arteriovenous fistulas pavf for aug 14 2025 05 45 et spinal simplicity secures fda breakthrough device designation for intralink spinal simplicity today announced that intralink an injectable device technology created to treat symptomatic disc degradation has been granted aug 05 2025 08 26 et infobionic ai announces fda clearance of its mome arc patch ushering in the next era of remote cardiac monitoring infobionic ai a leader in ai enabled remote cardiac monitoring today announced that the u s food and drug administration fda has granted 510 k jul 08 2025 08 00 et voiant expands regulatory capabilities with the completion of a successful fda remote regulatory assessment rra voiant a leader in clinical trial imaging solutions is pleased to announce the successful completion of its first fda remote regulatory assessment journalists and bloggers the news you need when you need it join pr newswire for journalists to access all of the free services designated to make your job easier in need of subject matter experts for your story submit a free profnet request and find the sources you need learn more 1 making a selection with these dropdown will cause content on this 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