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Home » Authors » Varun Saxena

Articles by Varun Saxena

Bioventrix completes first implant of newest heart failure device

May 17, 2016
By Varun Saxena

Robotic surgery player Transenterix reveals layoffs in face of the FDA's Surgibot rejection

May 12, 2016
By Varun Saxena
Struggling robotic surgery aspirant Transenterix Inc. is cutting staff in the U.S. and shifting its focus on the heels of the FDA's rejection of its Surgibot surgical robot. The Morrisville, N.C.-based company is instead aiming to secure FDA clearance of the CE-marked Alf-X surgical robot in 2017. A successful submission is crucial because company reported an operating loss nearly $15 million during the quarter, and said it has $75 million of cash-on-hand, enough to fund itself through the third quarter of 2017.
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Agency officials discuss need for increased cooperation between FDA and CMS

May 9, 2016
By Varun Saxena

Califf says FDA needs to integrate big data into decision making process

May 6, 2016
By Varun Saxena

Chinese researchers developing lab-on-a-chip sensor for measuring glucose levels via sweat

May 2, 2016
By Varun Saxena

FDA rejects Proteus' submission to use its ingestible sensor with Otsuka's Abilify

April 28, 2016
By Varun Saxena

FDA rejects Abilify with ingestible sensor; asks for more data

April 28, 2016
By Varun Saxena
A joint bid to deploy Proteus Digital Health Inc.'s ingestible sensor with Tokyo-based Otsuka Pharmaceutical Co. Ltd.'s antipsychotic drug, Abilify, was met with a complete response letter from the FDA.
Read More
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