7 medtech stories we missed this week: March 16, 2018

[Image from unsplash.com]From Intricon expanding its manufacturing space to Arthrex signing a global distribution deal, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Intricon expands medical footprint Intricon announced in a March 13 press release that it has signed a 5-year lease that will secure 30,000 sq. ft of manufacturing floor space near its Arden Hills, Minn. facility. The company is expanding its manufacturing capabilities to meet the demand of its growing medical business. Intricon’s manufacturing space will expand the company’s footprint by 30% and will house its robotic assembly of medical components and systems. The company also plans to expand its molding capacity with the new manufacturing space. 2. Arch Therapeutics pre-applies for another shot at FDA clearance Arch Therapeutics has filed a pre-submission with the FDA for feedback on its plan that will address FDA comments from its previous AC5 Topical Gel product 510(k) submission, according to a March 12 press release. Arch recently withdrew its 510(k) submission for its medical device after the FDA left comments in the late review process that the company could not completely respond to within the allotted 90-day period. The previous 510(k) that Arch Therapeutics submitted was a comprehensive battery of tests. The FDA requested that the company provide evidence that the topical gel did not cause sensitization in humans. 3. United Health Product...
Source: Mass Device - Category: Medical Devices Authors: Tags: 510(k) Contract Manufacturing Diagnostics Hospital Care Imaging Orthopedics Patient Monitoring Regulatory/Compliance Software / IT Spinal Arch Therapeutics Arthrex Inc. CellRight Technologies Enhatch Guided Therapeutics Inc. Source Type: news