• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer

Drug Delivery Business

  • Clinical Trials
  • Research & Development
  • Drug-Device Combinations
  • FDA
  • Pharmaceuticals
  • Policy

Medtech stories we missed this week: March 16, 2018

March 16, 2018 By Danielle Kirsh

missed medtech
[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 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.

Get the full story on our sister site, MassDevice.

Filed Under: Diagnostics, Featured, Food & Drug Administration (FDA), Hospital Care, Imaging, Implants, Orthopedics, Regulatory/Compliance, Wound Care Tagged With: archtherapeutics, arthrex, cellrighttechnologies, enhatch, Guided Therapeutics, intricon, Life Spine Inc., medtech, unitedhealthproducts

IN CASE YOU MISSED IT

  • Lyra Therapeutics appoints new chief medical officer
  • FDA lifts hold on Vertex’s insulin-producing cell therapy for diabetes
  • Retractable Technologies declares dividends
  • Teva appoints former Vertex exec as new head of R&D, CMO
  • West Pharmaceutical Services debuts new needle syringe system

Primary Sidebar

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Need Drug Delivery Business News in a minute? We Deliver!
Drug Delivery Enewsletters get you caught up on all the mission critical news you need in med tech. Sign up today.

Signup for the newsletter

Footer

Drug Delivery Business News Logo

MassDevice Medical NETWORK

MassDevice
DeviceTalks
Medical Tubing & Extrusion
Medical Design & Outsourcing
MedTech 100 Index
Drug Discovery & Development
Pharmaceutical Processing World
Medical Design Souring
R&D World

DRUG DELIVERY BUSINESS NEWS

Subscribe to Drug Delivery’s E-Newsletter
Advertise with us
About
Contact us
Privacy
Listen to our Weekly Podcasts
Add us on FacebookFollow us on TwitterConnect with us on LinkedIn

Copyright © 2022 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Advertise | Privacy Policy | RSS