Tag Archive for: FDA

Sequana Medical Announces US FDA Approval of alfapump® for the Treatment of Recurrent or Refractory Ascites due to Liver Cirrhosis

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alfapump® is the first US approved active implantable medical device (Class III) for the treatment of recurrent or refractory ascites due to liver cirrhosis PMA Approval and FDA Breakthrough Device Designation US market opportunity estimated at over $2 billion in 2025, growing at 9%[1] due to MASH/NASH[2] and alcoholic liver disease US commercial launch planned for H2 2025 […]

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SpliceBio Announces U.S. FDA IND Clearance of SB-007 to Commence Phase 1/2 Clinical Study in Patients with Stargardt Disease

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SB-007 is the only IND-cleared, clinical-stage therapeutic addressing the root cause of Stargardt disease with the potential to treat all patients across all ABCA4 mutations Phase 1/2 ASTRA study set to begin in the first half of 2025, supported by POLARIS, a pioneering company-sponsored natural history study in Stargardt disease First ever IND clearance for […]

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BrightHeart Secures FDA Clearance for First AI Software Revolutionizing Prenatal Fetal Heart Ultrasound Evaluations

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Paris, France – November 18th, 2024 – BrightHeart, a leading AI innovator in obstetric and pediatric cardiology technology, announces it has received FDA  510(k) clearance for its first artificial intelligence software, designed to transform prenatal ultrasound evaluations of the fetal heart. This milestone marks a significant breakthrough in one of the most challenging and critical […]

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Xeltis announces FDA Breakthrough Device Designation for aXess and first patient treated in US pivotal trial

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Designation recognizes aXess has the potential of providing a more effective vascular access option for dialysis patients, bringing significant advantages over current therapies First patient treated in US pivotal trial, marking significant clinical milestone EINDHOVEN, The Netherlands, 14 November 2024 – Xeltis, a leading developer of transformative implants that enable the natural creation of living […]

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Renovos Biologics strengthens its Board’s US expertise with appointment of Lisa Ferrara

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Lisa Ferrara, Ph.D., brings over 30 years of experience in orthopaedic medical device innovation and regulatory strategy in the USA Dr Ferrara will play a pivotal role in advancing Renovos’ lead product RENOVITE® BMP-2 through FDA regulatory approval in the USA RENOVITE® is a synthetic, biodegradable nanoclay carrier that is a novel therapeutic delivery platform […]

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