Avita Medical Ltd., of Melbourne, Australia, reported that it has submitted an investigational device exemption supplement to the U.S. FDA for the initiation of pivotal study to evaluate its Recell System for the treatment of vitiligo.
Cranford, N.J.-based Citius Pharmaceuticals Inc. said it has received positive feedback from the U.S. FDA on its proposed catheter compatibility studies for the Mino-Lok therapy, an antibiotic lock solution used to treat patients with central line-associated bloodstream infections and catheter-related bloodstream infections in combination with system antibiotics to preserve central venous access and reduce complications related to catheter removals and reinsertions. The studies, when successfully completed, should allow Mino-Lok to be labeled for use with all commercially available central venous catheters and peripherally inserted central catheters on the U.S. market.
Stanford spin-out Fibralign Corp., of Union City, Calif., has inked a long-term agreement with Tokyo-based Terumo Corp. to market and distribute its Biobridge Collagen Matrix in Japan for the treatment and prevention of secondary lymphedema.
Icometrix NV, of Leuven, Belgium, reported the launch of its icompanion platform and phone application for people with multiple sclerosis. The symptom- and treatment-tracking tool is currently available in English, French, German and Dutch.
Westport, Conn.-based Lumendi LLC reported the first endoscopic appendectomy using its Dilumen Endoluminal Interventional Platform. The procedure was performed at Mercy Medical Center in Baltimore, Md., to remove a lesion previously identified at the appendiceal orifice. The patient reported no post-procedure pain and resumed regular activity the following day.
Medx Health Corp., of Mississauga, Ontario, said it has launched an online marketing and awareness program through the Agoracom network.
Kilkenny, Ireland-based Mybio Ltd. has signed an exclusive distribution agreement with Mölab GmbH, of Unna, Germany, for its COVID-19 antibody test kit.
Myndtec Inc., of Mississauga, Ontario, has teamed up with Maness Veteran Medical LLC, of Waynesville, N.C., to distribute the Myndmove device to the U.S. Department of Defense and the Veterans Affairs Administration. The device treats arm and hand paralysis caused by stroke or spinal cord injury.
Nuprobe Inc., which has a presence in Houston and Shanghai, reported the worldwide exclusive in-license of two technologies from Rice University. The first, nonextensible oligonucleotides, will allow Nuprobe to provide much more rapid development of customized next-generation sequencing panels, with turnaround time of less than four weeks. The second, Linear DNA Assembly technology, improves the effective throughput of nanopore sequencing by up to 10-fold for short DNA. Concurrently, Nuprobe reported the launch of its new Varmap Nanopore product line.
Ourcrowd, of Jerusalem, reported the launch of its Pandemic Innovation Fund. The fund plans to raise $100 million for investment in urgent technological solutions for the medical, business, educational and social needs triggered by global pandemics and other health emergencies.
Pathgroup, of Brentwood, Tenn., reported the availability of a new, minimally invasive nasal swab collection option as a part of its comprehensive COVID-19 testing program.
Protech Home Medical Corp., of Wilder, Ky., has qualified to trade on the OTCQX Best Market.
Carlsbad, Calif.-based Qualigen Therapeutics Inc. released a prelaunch supply of its proposed Fastpack SARS-CoV-2 IgG Immunoassay diagnostic test kits to the University of Louisville to conduct validation studies with hundreds of patient samples, as well as for use in research on COVID-19.
Respira Technologies Inc., of West Hollywood, Calif., reported the launch of its pharmaceutical-focused commercial development program for the Respirx drug delivery device platform. Target indications for the Respirx include the treatment of asthma, COPD, potential vaccine delivery, pain management, nicotine replacement therapy, and investigative new drugs, such as inhalable insulin.
Leeds, U.K.-based prosthetics manufacturer, Steeper Group, has completed acquisition of the Espire Elbow prostheses range from College Park Industries, of Warren, Mich.
Surgery Exchange, of Atlanta, has launched an initiative to enable real-time connectivity between implant device manufacturers and health care providers. The network integrates directly with device manufacturers’ information technology systems and field applications to create a real-time, seamless flow of information between provider and device manufacturer.
Technopath Clinical Diagnostics, of Ballina, Ireland, is rolling out COVID-19 antibody testing in Ireland to help businesses navigate a safer workplace re-entry. This initiative will provide key services to all industries and will be offered on a not-for-profit basis.