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.
4. India approves Guided Therapeutics’s LuViva
Guided Therapeutics has received regulatory approval from the Indian Ministry of Health and Family Welfare for its LuViva device and disposables, according to a March 12 press release. The approval allows for the company to sell and commercialize its products throughout India. LuViva is a diagnostic device that scans the cervix using light and uses spectroscopy to measure how the light interacts with cervical tissues. Using spectroscopy, chemical and structural indicators of pre-cancer below the surface of the cervix can be identified. LuViva eliminates the need for laboratory analysis and tissue sampling by giving results immediately.
5. Enhatch launches custom ortho implant software
Enhatch announced in a March 9 press release that it has launched its Fit2Kit software that helps medical device manufacturers and orthopedic surgeons easily access the most up-to-date information about education materials, patient-specific planning software, inventory control, sales management tools and financial reporting. Enhatch’s algorithms turn CT scans and X-rays into 3D models that map the articular surface of a patient’s anatomy. Clinicians can then use the 3D model to choose a standard implant or make custom-fit implants.
6. Life Spine launches Sentry 2 lateral plating system
Life Spine recently launched its Sentry 2 Lateral Plating System in its first clinical use in Tampa, Fla., according to a March 7 press release. The Sentry 2 helps the surgeon perform complete stabilization and fixation while the patient is in a lateral decubitus position. The approach helps reduce the time and cost that usually comes with patient repositioning for posterior fixation.
7. Arthrex inks global distribution deal with Tissue Regenix’s CellRight Technologies
CellRight Technologies announced in a March 6 press release that it has signed a long-term, multi-year distribution agreement with Arthrex. The deal will provide surgeons with better access to osteobiologics and advanced surgical instrumentation and techniques to create better patient outcomes. Physicians and patients will have easier access to CellRight’s orthobiologics using Arthrex’s network.