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Prescient Surgical

5 medtech stories we missed this week: July 6, 2018

July 6, 2018 By Danielle Kirsh

From Zetta getting FDA clearance to Prescient Medical receiving CE Mark approval, here are five medtech stories we missed this week but thought were still worth mentioning. 1. Zetta wins FDA clearance for Zoom MRI software Zetta announced in a June 25 press release that its MRI software has received FDA 510(k) clearance. The software, known […]

Filed Under: Diagnostics, Food & Drug Administration (FDA), Hospital Care, Imaging, Implants, Patient Monitoring, Surgical Tagged With: LumiThera, MedTech, MIM Software, Prescient Surgical, RTI Surgical, Spectrum Dynamics, Zetta

7 medtech stories we missed this week: June 15, 2018

June 15, 2018 By Danielle Kirsh

From Cytosorbents opening a new U.S. manufacturing facility to DyAnsys received FDA clearance for a wearable to treat opioid withdrawals, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Cytosorbents opens new U.S. manufacturing facility CytoSorbents announced in a June 12 press release that it has opened a new […]

Filed Under: 510(k), Contract Manufacturing, Diagnostics, Digital Health, Food & Drug Administration (FDA), Hospital Care, Implants, Neuromodulation/Neurostimulation, Orthopedics, Regulatory/Compliance, Spine, Surgical Tagged With: Centinel Spine LLC, CytoSorbents Corp., dyansys, Globus Medical, MedTech, Optovue, Prescient Surgical, summitmedical

Prescient Surgical wins FDA nod for CleanCision wound retraction system

December 19, 2017 By Fink Densford

Surgical device spin-out Prescient Surgical said today it won FDA clearance for its CleanCision wound retraction and protection system. The San Carlos, Calif.-based company, which was spun out of the Stanford Byers Center for Biodesign in 2012, said its CleanCision device is the 1st in a new category of irrigating wound protection devices, as classified by […]

Filed Under: Food & Drug Administration (FDA), Regulatory/Compliance, Sterilization / Calibration, Wound Care Tagged With: Prescient Surgical

Prescient Surgical wins de novo FDA nod for CleanCision surgical wound cleaning device

January 24, 2017 By Fink Densford

Surgical device spin-out Prescient Surgical said today it won de novo clearance from the FDA for its CleanCision wound retraction and protection system designed to cleanse and protect surgical wound edges. The San Carlos, Calif.-based company said its CleanCision device is the 1st in a new category of irrigating wound protection devices, as classified by […]

Filed Under: Food & Drug Administration (FDA), Regulatory/Compliance, Surgical Tagged With: Prescient Surgical

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