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Results For "Breakthrough-Device-Designation"

25 News Found

U.S. FDA grants De Novo Clearance for Philips IVC filter removal laser sheath
Medical Device | December 23, 2021

U.S. FDA grants De Novo Clearance for Philips IVC filter removal laser sheath

Philips’s CavaClear is intended to safely ablate tissue to remove embedded IVC filters


U.S. FDA grants breakthrough designation to Datar’s blood test to detect breast cancer
Drug Approval | November 20, 2021

U.S. FDA grants breakthrough designation to Datar’s blood test to detect breast cancer

It is the first blood test able to detect early-stage Breast Cancer with high accuracy in women above the age of 40 years


Amber Implants VCFix spinal system receives breakthrough designation
Healthcare | October 05, 2021

Amber Implants VCFix spinal system receives breakthrough designation

The first clinical trial is expected to commence in early 2022 both in Europe and the US


U.S. FDA approves drug-free VNS system for stroke
Drug Approval | August 28, 2021

U.S. FDA approves drug-free VNS system for stroke

When used alongside rehabilitative exercise, this device may offer benefit to those who have lost function in their upper limbs due to ischemic stroke


Tesis Labs and Personal Genome Diagnostics tie-up to advance cancer treatment
Digitisation | August 11, 2021

Tesis Labs and Personal Genome Diagnostics tie-up to advance cancer treatment

The aim is to create new genomics solutions that could combat cancer and advance market access