ViewRay lands 510(k) for MRI-guided radiation therapy
Cleveland, Ohio-based ViewRay Inc. landed FDA clearance for its MRI-guided radiation therapy system, which delivers radiotherapy for cancer treatment during magnetic resonance imaging.
The system provides continuous soft-tissue imaging during radiotherapy treatment so physicians can watch and precisely record therapy delivery.
"It has already been an exciting year for ViewRay, with an additional round of funding and the installation of our first research systems at major U.S. medical centers," president & CEO Dr. Gregory Ayers said in prepared remarks. "Early clinical imaging studies have verified the quality of the system’s MR images, and now we’re looking forward to clinical applications."
ViewRay recently closed the final trance of a $45 million Series C venture capital financing round intended to push the company toward commercialization.
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Injex wins the FDA’s OK for needle-free injection technology
Injex Pharma won FDA clearance to market its Injex 30 needle-free injection technology, which has applications in dentistry, diabetes, cosmetic & beauty care, vaccines and erectile dysfunction.
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BioCer Entwicklungs touts CE Mark approval for its HaemoCer universal applicator
Germany-based BioCer Entwicklungs landed CE Mark approval in the European Union for its HaemoCer universal applicator for use in minimally invasive laparoscopic, spinal and other procedures.
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