Salutaris Medical Devices krijgt 510(k)-vergunning
BARCELONA, Spanje–(BUSINESS WIRE)– Salutaris Medical Devices (SalutarisMD ®) heeft op het Ophthalmology Futures European Forum 2015 bekendgemaakt dat zijn SMD Sr90-1 Radionuclide Brachytherapy Source (RBS) een 510(k)-autorisatie heeft gekregen van de Amerikaanse Food and Drug Administration (FDA). De SMD Sr90-1 RBS is bedoeld voor inwendige episclerale bestraling van tumoren of goedaardige groei. Het dient te worden toegepast in een handmatig bestuurbaar systeem voor inwendige bestraling.
Laurence Marsteller, ceo van SalutarisMD, zei: “Deze belangrijke wettelijke en commerciële mijlpaal valideert de vooruitgang die het bedrijf tot op heden heeft geboekt en helpt zijn onderzoeksprogramma vooruit.”
Salutaris Medical Devices Announces 510(k) Clearance
BARCELONA, Spain–(BUSINESS WIRE)– At Ophthalmology Futures European Forum 2015, Salutaris Medical Devices (SalutarisMD ®) announced that its SMD Sr90-1 Radionuclide Brachytherapy Source (RBS) received 510(k) clearance from the U.S. Food and Drug Administration (FDA). The SMD Sr90-1 RBS is indicated for episcleral brachytherapy of tumors and benign growths, and is intended for use within a manual brachytherapy applicator system.
Dr. Laurence Marsteller, CEO of SalutarisMD, observed, “reaching this important regulatory and commercial milestone further validates the company’s progress to date, and advances its clinical research agenda.”
Dr. Marsteller’s presentation at Ophthalmology Futures European Forum 2015 also included a review of recent study results from the SalutarisMD investigational therapy for wet Age-related Macular Degeneration (AMD) utilizing a single dose of episcleral brachytherapy. He concluded, “The study data are encouraging and bring us closer to offering this novel therapy, which is precise and customized, to patients.” (Caution: Investigational Device. Limited by Federal Law to Investigational Use in the United States.)
About SalutarisMD
SalutarisMD ® (Salutaris Medical Devices, Inc. and Salutaris Medical Devices, Ltd.) is a medical device company dedicated to developing minimally invasive, patient-centric treatments for vision loss. For more information visit www.SalutarisMD.com or www.SalutarisMD.co.uk.
About Ophthalmology Futures European Forum
Now in its 3rd year, Ophthalmology Futures Forums attract delegates, faculty and presenters from around the globe and from a wide spectrum of clinical and business specialities. Our clinician-driven Forums offer a combination of panels, company presentations and networking breaks to provide a unique platform that facilitates discussion between all stakeholders concerned with improving ocular health, and presents an exclusive environment for business conversation. For more information visit http://www.ophthalmology-futures.com.
Salutaris Medical Devices, Ltd.
Suite B212
Bessemer Building
Imperial College London SW72AZ
+44 (0) 203 282 7166
www.SalutarisMD.co.uk
Salutaris Medical Devices, Inc.
4330 N. Campbell Ave.
Tucson, AZ 85718
+1 520-638-7518
www.SalutarisMD.com
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Contacts
SalutarisMD
Joanne Vitali, US Communications Director
+1 610-518-5405
jvitali@SalutarisMD.com
or
Ama nda Thomas, UK Communications Director
+44 (0) 1582 623660/
+44 (0) 7746 708500 mobile
amanda@ajthomas.com