Press Releases
Phoenix Cardiac Devices, Inc., an innovator in cardiovascular medical device research and development, today presented pivotal data for its BACE™ (Basal Annuloplasty of the Cardia Externally) device, a novel modality for the treatment of Functional Mitral Regurgitation (FMR), at the virtual American Association for Thoracic Surgery (AATS) 101st annual meeting. In a late-breaking presentation, researchers reported positive outcomes including a reduction in the degree of FMR and stabiliza
Read more...GlossWire CEO and Founder Kimberly Carney’s commitment to connecting philanthropy to the beauty industry has been core to the DNA of the platform since day one. For the month of May, GlossWire will donate $1.00 USD for every download of the GlossWire mobile app to Seattle-based Cancer Cartel in support of their mission to provide financial relief for those fighting cancer by encouraging individuals to clean out their closets, allowing fashion and beauty to help fund the fight.
Read more...30 April 2021
Soliton, Inc.,, a medical device company with a novel and proprietary platform technology, announced the U.S. Food and Drug Administration ("FDA") clearance of the Company's special 510(k) for modifications to its RESONIC™ device. "We were thrilled to receive this clearance as it marks the last significant hurdle to our ability to initiate our commercial launch of the improved RESONIC device in the second quarter," stated Brad Hauser, Soliton CEO
Read more...Cerapedics Inc., an ortho-biologics company dedicated to enhancing the science of bone repair, announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation for its investigational P-15L Bone Graft for the treatment of degenerative disc disease (DDD). The FDA's Breakthrough Device designation is designed to expedite the development and review of medical devices that are intended to treat serious or life-threatening diseases. To qualify for this des
Read more...29 April 2021
Global MedTech pioneer MagVenture has received CE approval for the treatment of addiction and Obsessive-Compulsive Disorder (OCD). In addition, MagVenture TMS Therapy® can reduce the symptoms of comorbid anxiety in patients suffering from depression. These new approvals will expand the treatment options of MagVenture TMS Therapy® considerably, which has been CE approved for Major Depressive Disorder (MDD) since 2011. "These new CE approvals are based on the dedicated cl
Read more...29 April 2021
Smiths Medical, a leading medical device manufacturer, today announces the launch of the acapella® choice blue vibratory PEP therapy system. Acapella® is designed to aid in the removal of secretions for patients who have Cystic Fibrosis, Chronic Obstructive Pulmonary Disease (COPD), asthma, lung disease with secretory problems, and patients with atelectasis. Vibratory PEP therapy is a drug free supplemental treatment that can reduce COPD flare-ups1 and hospital length of sta
Read more...Varian, a Siemens Healthineers company, has signed an agreement with Australia’s Icon Group to provide 30 linear accelerators and associated treatment software to help tackle the growing global cancer burden. This agreement further strengthens the global partnership between Varian and Icon Group, together increasing access to care across regional and underserviced areas in Australia and Asia. The order is comprised of a variety of Varian linear accelerators and software includ
Read more...Medtronic plc, the global leader in medical technology, today announced approval from the U.S. Food and Drug Administration (FDA) to proceed with an investigational device exemption (IDE) trial to evaluate its internally developed implantable tibial neuromodulation (TNM) device — a therapy designed to provide relief from symptoms of bladder incontinence. The TITAN 1 Feasibility Study is a prospective, multicenter, feasibility study to characterize the procedure for the implantable TNM d
Read more...27 April 2021
BD (Becton, Dickinson and Company), a leading global medical technology company, today announced it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for the BD Alaris™ System, the most widely used infusion pump in acute care hospitals across the United States. The 510(k) submission is intended to bring the regulatory clearance for the BD Alaris™ System up to date, implement updated features and address open recall issues, inclu
Read more...Inspire Medical Systems, Inc., a medical technology company focused on the development and commercialization of innovative and minimally invasive solutions for patients with obstructive sleep apnea (“OSA”), today announced an exclusive distribution agreement with Japan Lifeline Co., Ltd. (“JLL”), an independent full-service distributor of medical devices, to commercialize Inspire therapy in Japan. The parties entered into this agreement following successful completion
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