Page 23 - Device Designation News Today

EPFL spin-off Rheon Medical has developed the world's first adjustable glaucoma drainage system, which has already been used successfully in over 250...

The round was led by Hanaco Ventures, alongside Dexcel Pharma, and Peregrine Ventures, bringing the total funding to over $50 million. Funds to be used to support company’s pivotal trials for stroke survivors in U.S. hospitals

The Jerusalem-based company's investigational cloud-based technology aims to reduce disability and promote rehabilitation neurorecovery for stroke victims.

Founded in 2016, Alpha Tau developed a breakthrough cancer treatment called Alpha DaRT (Dіffusіng Alpha-emіtters Radіatіon Therapy).

AI Cancer Diagnostics Firm Ibex Granted FDA Breakthrough Device Designation News BriefsTech & Innovation Pathologists review a cancer alert on Ibex’s AI solution. Courtesy Israeli AI-powered cancer diagnostics company Ibex Medical Analytics announced on Wednesday that it was granted Breakthrough Device Designation by the US Food and Drug Administration (FDA) for its Galen platform that helps pathologists detect and grade cancer in biopsies. Ibex’s Galen Prostate and Galen Breast are the fi...

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 thr...

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...

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 no...

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: M...