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Synchron’s flagship StentrodeTM endovascular implant does not require open brain surgery and has obtained FDA Breakthrough Device Designation for the treatment of paralysisThe New York based company is already conducting human trials in Australia and is expected to commence a U.S. clinical trial in 2021NEW YORK--(BUSINESS WIRE)--Synchron, a brain interface platform company,

Photo by kate-sept2004/Getty Images Digital mental health company Woebot Health has landed FDA Breakthrough Device Designation for its postpartum depression digital therapeutic, WB001. WB001 combines cognitive behavioral therapy and elements of interpersonal psychotherapy with the company’s conversational chatbot, Woebot, to deliver treatment directly through patients’ phones. Designed as a prescription digital therapeutic, the eight-week program treats symptoms of postpartum depression through lessons that attempt to normalize and contextualize the postpartum experience. Specifically, th...

Product News: Molzym announces FDA Breakthrough Device Designation for its molecular diagnostic test system FDA Breakthrough Device Designation for Sepsis, Joint & Implant Infections, Infective Endocarditis, Bacterial Meningitis 13 May 2021 Molzym’ s unique technology for molecular microbial diagnostics was granted Breakthrough Device Designation (BDD) by the FDA in light of its capacity to aid the diagnosis of Bloodstream Infection/Sepsis, Joint and Implant Infections, Infective Endocarditis, and Bacterial Meningitis as an adjunct to the current standard of care. The FDA BDD Program aims a...

IceCure Reports Positive Results In Tumor-Freezing Breast Cancer Trial Israeli biomedical company IceCure Medical, the developer of technology that freezes cancerous tumors, announced positive results this week from the company’s clinical trial for the use of its ProSense flagship system for cryoblation of small low-risk breast cancer tumors.  The ProSense is a liquid-nitrogen-based cryoablation system used in the treatment of patients with T1 invasive breast cancer or patients who are not suited for surgical alternatives for the treatment of breast cancer. The system is one of two cry...

Health Crisis Leads to Surge in Medical Technology Innovation FN Media Group Presents Microsmallcap.com Market Commentary NEW YORK, May 7, 2021 /PRNewswire/ -- A combination of medical applications for digital internet-of-things technologies coming into their own, and an explosion of interest in the healthcare sector spurred on by the global health crisis is sending the healthcare technology space into a period of incredible innovation. Healthcare technology companies like Mednow Inc. (TSXV: MNOW), Medtronic plc (NYSE:M DT), and Amwell (NYSE: AMWL) are developing new systems and devices to...