Epitomee Medical Ltd submitted its application to the U.S. FDA for 510k regulatory clearance for its swallowable weight loss capsule. It joins a host of companies offering solutions to the global obesity crisis.
Watertown, Mass.-based Lyndra Therapeutics Inc. is seeking patent protection for gastric residence drug delivery systems with improved shelf lives through their inclusion of a metal core.
The U.S. FDA granted Virtual Incision Corp. de novo marketing authorization for its miniaturized in vivo robotic assistant for use in colectomy procedures in adults. The two-pound device offers portability and quick setup, eliminating the need for specialized operating rooms or arrangements to accommodate robotics.
Holliston, Mass.-based Harvard Apparatus Regenerative Technology Inc. (HART) is seeking patent protection for synthetic structural support devices for use in esophageal tissue regeneration, in which the synthetic structural supports have been seeded with cells (e.g., mesenchymal stem cells) to form a cellular sheath on the supports’ outer surfaces.
Researchers from the University of Michigan have filed for patent protection of methods and systems to identify actual esophageal tissue changes and/or damage during cardiac ablation procedures.
Neuroimmune modulation using vagus nerve stimulation (VNS) reduced Crohn’s disease symptoms and improved patient quality of life, a study published in the Journal of Crohn’s and Colitis found. The research by Setpoint Medical Corp. could provide a better option for patients with the autoimmune disorder than biologics, which often fail to work over time and can cause significant adverse effects.
Bariatek Medical SA’s team of inventors reported on a patent for a delivery system for introducing or deploying a gastrointestinal implant, particularly a bypass sleeve used to treat obesity and diabetes.
Laborie Medical Technologies Inc. continued a string of recent deals with an agreement to acquire Urotronic Inc. for $255 million cash up front with an additional $345 million in payments contingent on meeting specified commercial and reimbursement milestones. Laborie already held a minority interest in the manufacturer of the Optilume drug-coated balloon technology for treatment of urethral strictures and benign prostatic hyperplasia (BPH).
Neuraxis Inc. has initiated a clinical study to evaluate the efficacy of its IB-Stim neuromodulation system in treating children with post-concussion syndrome (PCS). The aim is to see whether IB-Stim can ease the constellation of symptoms that occur after mild traumatic brain injury such as headaches, dizziness and problems with concentration and memory.
Levita Magnetics International Corp. received uplifting news this week as the U.S. FDA cleared its magnetic-Assisted Robotic Surgery (MARS) minimally invasive surgical platform. MARS builds on the company’s first product, the Levita magnetic surgical system, by providing greater control of surgical instruments to surgeons. The platform is cleared for use in bariatric, colorectal, gallbladder and prostate surgeries.
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