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 Products wins CE Mark for HemoStyp gauze
United Health Products announced in a March 13 press release that it has received CE Mark approval for its HemoStyp hemostatic gauze. The gauze is designed to be used in healthcare and wound care and is approved to be used for internal surgical procedures in more than 30 countries.
At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos.
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