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December 16, 2021
IQX Limited (NSX:IQX) has filed an application with the U.S Food and Drug Administration (FDA) for Breakthrough Device Designation.
December 15, 2021
/PRNewswire/ -- Life Science Biosensor Diagnostics Pty Ltd (LSBD), a life sciences and medical technology company and subsidiary of The iQ Group Global,...
December 15, 2021
SYDNEY, Dec. 15, 2021 /PRNewswire/ — Life Science Biosensor Diagnostics Pty Ltd (LSBD), a life sciences and medical technology company...
December 14, 2021
NEW YORK, Dec. 13, 2021 (GLOBE NEWSWIRE) -- GBS Inc. (Nasdaq: GBS), a life sciences company developing non-invasive, real-time diagnostic testing for...
December 1, 2021
Falls Church, VA (PRWEB) December 01, 2021 -- Special Pathways for Innovative Devices: A Guide to the FDAโs Breakthrough Device and Safer Technologies
October 29, 2021
/PRNewswire/ -- Renovia Inc. ("Renovia"), a women-led company that develops digital therapeutics for female pelvic floor disorders, announced today that the...
October 5, 2021
The MCIT/RN Rule was intended to address concerns that delay or uncertainty around Medicare coverage hampered beneficiary access to innovative technologies.
April 5, 2021
By Yakir Benzion, United With Israel The Israeli medical device company IceCure received a huge boost after American authorities approved the companyโs revolutionary ProSense system for treating cancerous tumors by freezing them, Globes reported Sunday. The U.S. Food and Drug Administration (FDA) gave marketing approval to ProSense as part of the FDAโs Breakthrough Devices Program that fast-tracks new devices to the market. Based in Caesarea, north of Tel Aviv, and with offices in America,...
April 4, 2021
Shoshanna Solomon is The Times of Israels Startups and Business reporter The technology developed by IceCure Medical Ltd. destroys tumors by freezing them in a minimally invasive procedure with no surgery or hospitalization requirement (Courtesy) IceCure Medical, an Israel-based maker of tumor-freezing technology, said Sunday that it had received notification from the US Food and Drug Administration recognizing its ProSense product as a โbreakthrough deviceโ to freeze tumors in a number of...