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Novian Health Gains FDA Breakthrough Designation for Novilase Breast Therapy

In Clinical Studies News by Barbara Jacoby

Groundbreaking laser therapy offers alternative to surgery for breast cancer Novian Health Inc. has been granted Breakthrough Device designation from the U.S. Food and Drug Administration for its Novilase®Interstitial Laser System and its proposed indication for use: the focal destruction of malignant breast tumors in adult women who seek a breast conserving procedure. The FDA’s Breakthrough Device program supports the …

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Cryoablation Technology for Early Breast Cancer Earns Breakthrough Therapy Designation

In In The News by Barbara Jacoby

By: Audrey Sternberg From: cancernetwork.com The next-generation cryoablation technology ProSense was granted breakthrough device designation to treat certain patients with T1 breast tumors. Breakthrough device designation was granted to the next-generation cryoablation technology ProSense for use in patients with T1 invasive breast cancer as well as in patients not suitable for surgical alternatives for the treatment of their tumors, reported IceCure …

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Cytotron® Granted ‘Breakthrough Device Designation’ by U.S. FDA for Treatment of Breast, Liver, and Pancreatic Cancers

In Clinical Studies News by Barbara Jacoby

Source: Shreis Scalene Sciences From: prnewswire.com The Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA) granted Shreis Scalene Sciences (Shreis), in Gaithersburg, MD, ‘Breakthrough Device Designation’ for the CYTOTRON® – a CE marked, whole-body therapeutic medical device. “We are confident that the FDA will continue to interact with Shreis under the premises of …

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FDA Grants Breakthrough Device Designation to the Prescient Metabiomics LifeKit® Prevent Test for the Early Detection of Colon Polyps and Colon Cancer

In Clinical Studies News by Barbara Jacoby

Source: Prescient Medicine From: PR Newswire Prescient Metabiomics, a privately held company and a subsidiary of Prescient Medicine Holdings, Inc., announced that the U.S. Food and Drug Administration (FDA) has granted the company’s submission for Breakthrough Device designation to its LifeKit® Prevent Colorectal Neoplasia Test. This Breakthrough Device designation is the first designation for a non-invasive diagnostic test that is designed to …