AI Medical Service said today that it raised nearly $43 million in Series B funding, bringing its total funding close to $60 million over the past three years. The Tokyo-based company said that, combined with the more than $9 million it raised in an August 2018 financing round, it has raised approximately $57 million since […]
Endoscopic
Medtronic releases new data on Endurant, Valiant Navion stent grafts
Medtronic (NYSE:MDT) today released new data on its stent graft program at the Charing Cross Symposium in London, touting two-year results for its Endurant line and 30-day data from a pilot study of its Valiant Navion device. The Fridley, Minn.-based medtech giant said preliminary two-year results from a study of the Endurant II/IIs devices, used […]
FDA: Duodenoscope reprocessing is dirtier than we thought
The FDA said today that new data show that the contamination rate for “high-concern organisms” in duodenoscopes is nearly twice as high as previously thought and warned the devices three major manufacturers to get their required post-market studies in gear. Back in 2015 the federal safety watchdog warned Olympus (TYO:7733), Fujifilm Holdings (TSE:4901) and Hoya’s (TYO:7741) Pentax subsidiary following a string […]
First U.S. patient treated with Cook Medical endovascular aortic dissection system
Cook Medical has launched its Zenith dissection endovascular system, recently approved by the FDA. The first patient was treated with the system at Cooper University Health Care in Camden, N.J., Cook Medical announced yesterday. The Zenith system was designed to provide physicians with a less-invasive alternative to open surgery for repair of Type B dissections of […]
Endologix readies for 1-for-10 reverse split
Endologix (NSDQ:ELGX) said yesterday that its board of directors set the ratio for its reverse stock split at 1-for-10. Beginning today, Endologix’s common stock will trade on the Nasdaq Global Select market on a reverse stock split-adjusted basis, the Irvine, Calif.-based company reported. Following the reverse split, there will be roughly 10.3 million shares of issued […]
Endologix misses the mark with Q4, 2018 numbers
Endologix (NSDQ:ELGX) this week posted fourth-quarter and full-year results that missed the consensus forecasts for sales and earnings for both periods. The Irvine, Calif.-based stent graft maker’s losses grew 78.7% to -$26.0 million, or -26¢ per share, on sales growth of -18.6% to $24.0 million for the three months ended Dec. 31, 2018, compared with the […]
Apollo Endosurgery touts results of stomach-stapling study
Apollo Endosurgery (NSDQ:APEN) has reported key data from 1,000 patients who underwent endoscopic gastroplasty using the company’s OverStitch device. Published in the journal Gastrointestinal Endoscopy, the data include a mean total weight loss of 14.8%±8.5% at 18 months. Three months following surgery, the impact on obesity-related comorbidities included the complete remission of: 13 of 17 cases […]
Cook Medical wins FDA nod for Zenith aortic dissection repair stent
Cook Medical said today that it won FDA approval for its Zenith Dissection endovascular system intended to treat Type B aortic dissections. The Bloomington, Ind.-based company’s newly cleared system consists of a proximal stent-graft component and bare stent distal component and is intended to prove a less invasive alternative to open surgery for repairing Type B […]
Ascyrus Medical wins CE Mark for aortic dissection stent
Ascyrus Medical said today that it won CE Mark approval in the European Union for its Ascyrus Medical Dissection Stent, or AMDS, intended for treating acute type A aortic dissections. The Boca Raton, Fla.-based company’s AMDS is an arch remodeling hybrid graft designed as an adjunct to surgical reconstruction, and is intended to reduce the […]
Medtronic touts study data for thoracic aortic stent
Medtronic (NYSE:MDT) said that its thoracic stent graft for the treatment of a potentially deadly blunt-force chest injury performed well five years after implantation, according to a new study. The Rescue study of the long-term durability, safety, and efficacy of the Medtronic’s Valiant Captivia thoracic stent graft system for blunt thoracic aortic injury (BTAI) was presented […]
FDA clears Rebound Therapeutics’ minimally invasive neurosurgical endoscope
Rebound Therapeutics has secured FDA 510(k) clearance for its Aurora Surgiscope system, which it touts as the first single-use disposable neurosurgical endoscope. The Aurora system enables minimally invasive access, visualization and illumination during neurosurgical procedures, the Irvine, Calif.–based company said yesterday. “Our physician advisors specified that we enable the complete neurosurgical procedure, without reliance on any […]