Olympus (TYO:7733) announced today that it received FDA de Novo classification for its iTind non-surgical device for treating benign prostatic hyperplasia (BPH). Israel-based medical device manufacturer Medi-Tate originally designed the iTind device. Olympus holds the exclusive right to distribute Medi-Tate products in the U.S. through a strategic investment. The iTind is designed as a flexible, three-strut […]
Medi-Tate wins strategic investment from Canada’s Laborie Medical Technologies
Laborie Medical Technologies said it took out a stake in Israel’s Medi-Tate, which is developing devices to treat enlarged prostates, for an unspecified amount. Toronto-based Laborie, which is owned by private equity company Audax Group, in October 2013 acquired the pelvic muscle rehabilitation business of UroMed Technology, also for an undisclosed amount. Akiva, Israel-based Medi-Tate developed a minimally invasive […]
St. Jude lands FDA win for 2 next-gen cardiac ablation catheters | Regulatory Roundup
St. Jude Medical Inc. (NYSE:STJ) won pre-market approval for 2 next-generation cardiac ablation systems this month, the Therapy Cool Path Duo and Safire Blu Duo catheters.
Both ablation systems use radiofrequency energy to freeze small areas of faulty cardiac tissue in patients with typical trial flutter, a type of arrhythmia in which patients experience abnormal heart rhythms or an abnormally fast heartbeat in the upper chambers of the heart.
