QT Vascular said today that it launched the U.S. pivotal trial for its Chocolate Touch drug-coated peripheral balloon in the hopes of winning FDA approval. The device won CE Mark clearance in September 2015. The trial is slated to compare the safety and effectiveness of the Chocolate Touch balloon with Bard‘s(NYSE:BCR) Lutonix drug-coated balloon catheter. […]
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Aerie inks deal for implantable drug-delivery system
Aerie Pharmaceuticals (NSDQ:AERI) said today that it inked a collaborative R&D and licensing agreement with DSM to develop an implantable drug-delivery system for patients with glaucoma and other retinal diseases. DSM has reportedly developed an injectable drug-delivery fiber using polyesteramide polymers that has proven successful in preclinical work with Aerie’s compounds. A product candidate developed by […]
Omnicell shares surge after Q2 beat
Shares in Omnicell (NSDQ:OMCL) soared today after the company beat expectations on Wall Street with its second quarter results. The Mountain View, Calif.-based company posted profits of $837,000, or 2¢ per share, on sales of $180.9 million for the 3 months ended June 30, for sales growth of 4.6% compared with the same period last […]
Medtech stories we missed this week: July 28, 2017
From Accenture’s AI-powered app to help the visually impaired to Rayovac getting clearance from Health Canada, here are seven medtech stories we missed this week but still thought were worth mentioning. 1. Accenture touts AI-powered app for visually impaired Accenture announced in a July 28 press release that it has developed an artificial intelligence–powered way to […]
Cyber attack stalls manufacturing for Merck, narrows outlook
Merck (NYSE:MRK) narrowed its full-year earnings outlook while announcing its second quarter results today. The company revealed that an international cyber attack, which hit the drugmaker in June, halted some of its manufacturing operations. While touting its second quarter financial results, Merck said that it doesn’t yet fully comprehend the magnitude of the disruption caused by […]
Tandem shares slide after Q2 sales miss
Shares in Tandem Diabetes Care (NSDQ:TNDM) fell yesterday after the medical device maker missed sales expectations but beat EPS estimates on Wall Street with its second quarter results. The San Diego, Calif.-based company posted a loss of -$21.8 million, or -44¢ per share, on sales of $21.3 million for the 3 months ended June 30, for […]
Prolonging the lives & independence of Alzheimer’s patients with artificial intelligence
With modern medicine and public health measures extending the average person’s life expectancy, a growing population is coming face to face with the challenges of age – including cognitive decline. Addressing the needs of people dealing with cognitive change is no simple task. And today’s healthcare workers are hungry for objective, meaningful data to help […]
West misses on sales, beats EPS in Q2
Shares in West Pharmaceutical (NYSE:WST) fell today after the manufacturer missed sales estimates on Wall Street with its second quarter results. The Exton, Penn.-based company posted profits of $38.8 million, or 51¢ per share, on sales of $397.6 million for the 3 months ended June 30, for bottom-line loss of -13% on sales growth of […]
United Therapeutics logs Q2 beat
Shares in United Therapeutics (NSDQ:UTHR) fell today even though the biotech beat expectations on Wall Street with its second quarter results. The company recorded a net loss for the quarter and revealed that it has set aside $210 million for a possible settlement with the Dept. of Justice, according to United’s quarterly regulatory filing. The DOJ […]
FDA grants priority review to Kaleo’s auto-injector for infants, kids
Kaleo said today that the FDA granted priority review to a supplemental new drug application for Kaleo’s Auvi-Q 0.1 milligram epinephrine auto-injector. The privately-held pharmaceutical company touted this version of its device as the first specifically designed for the treatment of life-threatening allergic reactions in infants and small kids. The 0.1 mg auto-injector sports a […]