Lowell, Mass.-based startup Launchpad Medical LLC has picked up an additional $1.8 million grant from the Michigan-Pittsburgh-Wyss Regenerative Medicine Resource Center to advance the development of its bone graft solution. The company plans to use the funds to conduct a pivotal animal study of the injectable biomaterial, which will pave the way for a U.S. FDA-approved clinical trial.
Ortek Therapeutics Inc., of Roslyn Heights, N.Y., has officially launched its electronic early cavity detection system, the Ortek-ECD. The U.S. FDA-cleared device can detect dental lesions before they show up on X-rays, enabling less invasive treatment and preventing greater damage to the tooth structure. Ortek holds the exclusive license for the device which was developed at Stony Brook University School of Dental Medicine.
San Jose, Calif.-based Align Technology Inc. has won the FDA’s nod for its Itero Element 5D imaging system. The company said the Itero Element 5D is the first intraoral scanner with near-infrared imaging (NIRI) technology that visualizes the internal structure of the tooth in real time. The FDA cleared the device for the detection of interproximal caries lesions above the gingiva and for monitoring the progress of such lesions.