Oramed Pharmaceuticals (NSDQ:ORMP) said today that the FDA scheduled an end-of-phase II meeting with the Jerusalem-based company for August 31. Oramed is developing an oral insulin capsule for the treatment of Type II diabetes. The company’s Phase IIb trial met primary and secondary endpoints, since the insulin capsule lowered patients’ blood sugar relative to a placebo. […]
Food & Drug Administration (FDA)
Stryker wins FDA 510(k) for MultiGen 2 RF generator
Stryker (NYSE:SYK) said today it won FDA 510(k) clearance for its MultiGen 2 radiofrequency energy generator designed for RF ablation procedures. The newly cleared MultiGen 2 generator is designed with double the industry standard for power to achieve its target temperature faster with fewer errors and increased reliability and efficiency, the Kalamazoo, Mich.-based company said. “The […]
FDA accepts Axium’s orphan designation request for intranasal Truveta
Axium Pharmaceuticals said today that the FDA accepted its orphan designation request for the intranasal administration of lorazepam, Truveta, in the treatment of Lennox-Gastaut syndrome. The High Point, N.C.-based company is developing a novel intranasal administration device for new formulations of existing drugs. Axium said the device is designed to bring about rapid onset of a […]
Ocular seeks to extend regulatory timeline for Dextenza due to manufacturing concerns
Ocular Therapeutix (NSDQ:OCUL) said today that it submitted details of a manufacturing equipment change as an amendment to the new drug application resubmission for Dextenza, the company’s dexamethasone insert that is currently under review by the FDA. The FDA is slated to make a decision about the product’s regulatory approval by July 19. But the company recently […]
FDA clears Medtronic’s CoreValve Evolut TAVR in intermediate risk patients
Medtronic (NYSE:MDT) said today it won expanded FDA approval for its CoreValve Evolut transcather aortic valve replacement platform, now indicated for patients with symptomatic severe aortic stenosis who are at an intermediate risk for open heart surgery. The Fridley, Minn.-based company said that patients at intermediate risk for open-heart surgery have a mortality risk of greater than […]
Ocular Therapeutix faces more manufacturing problems as FDA decision deadline looms
Shares in Ocular Therapeutix (NSDQ:OCUL) fell last week after the company revealed that it received another letter from the FDA about issues spotted by the regulatory agency during a pre-approval inspection of a manufacturing plant. This isn’t the first time that the company has dealt with manufacturing issues. In July last year, the FDA denied approval for Ocular’s hydrogel plug, Dextenza, […]
FDA OKs Intact Vascular IDE app for 6-month endpoint in BTK Tack angioplasty trial
Intact Vascular said today that the FDA approved an investigational device exemption supplemental application to modify the primary endpoint in a below-the-knee clinical trial of its Tack optimized balloon angioplasty from 12 months to 6 months. The Tack endovascular system is designed to repair dissections that occur as a complication of balloon angioplasty. The system allows […]
FDA clears first new sickle cell treatment in 20 years
Emmaus Life Sciences said last week that the FDA approved its L-glutamine oral powder, Endari, as a therapy to lessen the complications of sickle cell disease in patients ages 5 and older. The drug’s approval was supported by data from a Phase III trial evaluating Endari compared to a placebo in 230 adults and children with […]
7 medtech stories we missed this week: July 7, 2017
From EnvisionTEC’s FDA approval to InVivo Therapeutics adding a new clinical site, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. EnvisionTEC wins FDA nod for 3D printing E-Denture material EnvisionTEC announced in a June 30 press release that it has received FDA approval for its E-Denture material […]
DeviceTalks Q&A: Regulatory experts talk medtech policy
A panel of regulatory experts convened at DeviceTalks Minnesota this year to chat with MassDevice.com editor Sarah Faulkner. The group of regulatory experts included Danelle Miller, VP of regulatory policy & intelligence at Roche Diagnostics; Megan Brandt, VP of regulatory affairs and quality assurance at CHF Solutions (NSDQ:CHFS); and Mac McKeen, regulatory science fellow at Boston Scientific (NYSE:BSX). Faulkner: We […]
Cardiologs wins FDA 510(k) for ECG analysis platform
Cardiologs Technologies said today it won FDA 510(k) clearance for its Cardiologs ECG analysis platform designed to aid in the screening for atrial fibrillation and other arrhythmias. The platform is a cloud-based cardiac monitoring and analysis web service which uses artificial intelligence to analyze long-term ambulatory ECG monitoring recordings, the Paris-based company said. The system […]