Salutaris Medical Devices meldet FDA-510(k)-Zulassung

BARCELONA, Spanien–(BUSINESS WIRE)–Salutaris Medical Devices (SalutarisMD®) gab auf dem Ophthalmology Futures European Forum 2015 bekannt, dass seine SMD Sr90-1-Radionuklid-Brachytherapie-Strahlenquelle (RBS) die Zulassung der US-Gesundheitsbehörde nach dem 510(k)-Verfahren erhalten hat. Die SMD Sr90-1 RBS ist bei der episkleralen Brachytherapie von Tumoren und gutartigen Wucherungen angezeigt und für die Verwendung in einem manuellen Brachytherapie-Applikator-System bestimmt. Dr. Laurence Ma


Salutaris Medical Devices annonce avoir reçu une homologation 510(k)

BARCELONE, Espagne–(BUSINESS WIRE)–À l’occasion de l’Ophthalmology Futures European Forum 2015, Salutaris Medical Devices (SalutarisMD®) a annoncé que sa source de curiethérapie à radionucléides (SCR) SMD Sr90-1 a obtenu l’homologation 510(k) de l’Agence américaine des produits alimentaires et des médicaments (la « FDA »). La SCR SMD Sr90-1 est indiquée pour la curiethérapie épisclérale des tumeurs et des croissances bénignes, elle est prévue pour une utilisation dans un système applicateur d


Ocata receives NEI grant to develop photoreceptor progenitor cell therapy

Ocata Therapeutics received a Small Business Innovation Research grant from the National Eye Institute to fund preclinical development of its propriety photoreceptor progenitor cell therapy for retinal degenerative diseases, according to a press release.Previous animal studies have shown that the renewable populations of retinal photoreceptor cells “can integrate into damaged retina, promote survival of host photoreceptors, and restore vision in completely blind animals, using either embryonic stem cells or induced pluripotent stem cells as source material,” Robert Lanza, MD, principal investigator of the grant and chief scientific officer at Ocata, said in the release.

Valeant to acquire Synergetics USA

Valeant Pharmaceuticals announced that it will acquire Synergetics USA for $6.50 per share in cash, according to a Valeant press release.“The addition of Synergetics’ portfolio of instruments and devices will further enhance Bausch + Lomb’s presence around the world in the rapidly evolving field of vitreoretinal surgery,” J. Michael Pearson, chairman and CEO of Valeant, said in the release. “We are committed to delivering a valuable and broad array of surgical devices and instruments to serve the needs of the surgical retina community and their patients.”