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Medizone

7 medtech stories we missed this week: March 23, 2018

March 23, 2018 By Danielle Kirsh

From Medizone’s evaluation deal to Advantis Medical Imaging getting CE Mark approval, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Medizone inks AsepticSure evaluation deal with commercial cleaning products maker Innovasource Medizone announced in a March 22 press release that it has signed a product evaluation agreement with […]

Filed Under: 510(k), Food & Drug Administration (FDA), Hospital Care, Imaging, Implants, Patient Monitoring, Regulatory/Compliance, Respiratory Tagged With: advantismedicalimaging, aziyobiologics, Balt, endospan, Medizone, MedTech, Olympus, Respiratory Motion

InVivo Therapeutics lifts Toselli to permanent prez, CEO | Personnel Moves February 6, 2018

February 6, 2018 By Fink Densford

InVivo Therapeutics (NSDQ:NVIV) said yesterday it made Dr. Richard Toselli’s spot in the corner office permanent, lifting him from acting CEO to prez and CEO. Dr. Toselli will maintain his position on the company’s board and as its chief medical officer, the position he was given when he joined the company last July. Prior to joining InVivo, […]

Filed Under: Business/Financial News Tagged With: Alcon, Baxter, Boston Scientific, Faxitron, GE Healthcare, InVivo Therapeutics, Johnson and Johnson, Lima Corporate, Luxottica, Medizone, Medtronic, performancehealth, Respicardia, Robocath, Sanofi-Aventis, T2 Biosystems Inc.

Medizone to launch further AscepticSure testing in pursuit of FDA de novo pathway

January 19, 2018 By Fink Densford

Medizone International (OTC:MZEI) said yesterday that following meetings with the FDA, it has decided to pursue de novo clearance with the agency for its AscepticSure disinfection system, and such pursuit will require further data collection on the device. The AsepticSure system is designed to be turned on from outside the room to be disinfected, enabling the machine […]

Filed Under: Food & Drug Administration (FDA), Regulatory/Compliance, Sterilization / Calibration Tagged With: Medizone

Sterilis taps ex-Nanosphere CEO McGarrity as chief exec | Personnel Moves – November 1, 2017

November 1, 2017 By Fink Densford

Medical sterilization company Sterilis said yesterday it tapped former Nanosphere (NSDQ:NSPH) chief exec Michael McGarrity as its new CEO. McGarrity held the CEO position at Nanosphere from February 2013 to last June when he oversaw the company’s $76.9 million acquisition by Luminex (NSDQ:LMNX). Prior to his time as head of Nanosphere, McGarrity held positions in sales, marketing […]

Filed Under: Business/Financial News Tagged With: AdvaMed, Alphatec, Baylis Medical, Boston Scientific, cathworks, ev3 Inc., Home Diagnostics Inc., Integra LifeSciences, Invuity, linkspine, Luminex, Medicrea, Medizone, Nanosphere, Second Sight, sterilis, Stryker, Varian Medical Systems, Vertos Medical

Medizone wins CE Mark for AsepticSure

October 16, 2017 By Brad Perriello

Medizone International (OTC:MZEI) said today that it won CE Mark approval in the European Union for its AsepticSure disinfection system. The AsepticSure system is designed to be turned on from outside the room to be disinfected, enabling the machine to safely fill the room with a disinfecting gas formula. The device later clears the atmosphere […]

Filed Under: Hospital Care, Regulatory/Compliance, Sterilization / Calibration Tagged With: Medizone

Relievant Medsystems taps ex-Cameron Health chief Hykes for CEO | Personnel Moves, Sept. 26, 2017

September 26, 2017 By Brad Perriello

Relievant Medsystems said it named former Cameron Medical chief Kevin Hykes to be its new CEO, effective immediately. Hykes, who led Cameron Health to a $1.35 billion buyout in 2012 by Boston Scientific (NYSE:BSX), replaced Alex DiNello, who was named COO, Relievant said. Relievant makes the Intracept device for treating lower back pain. Hykes was most recently […]

Filed Under: Wall Street Beat Tagged With: Breathtec Biomedical Inc, Histogenics, HistoSonics Inc., integer, lombardmedical, Masimo, Medizone, pulmodyne, Relievant Medsystems Inc., RTI Surgical

Medizone to pursue de novo pathway for AsepticSure disinfection system

August 29, 2017 By Fink Densford

Medizone said last week it will pursue de novo clearance for its AsepticSure disinfection system after speaking with the FDA about its 513(g) submission. The AsepticSure system is designed to be turned on from outside the room to be disinfected, enabling the machine to safely fill the room with a disinfecting gas formula. The device […]

Filed Under: Food & Drug Administration (FDA), Regulatory/Compliance, Sterilization / Calibration Tagged With: Medizone

Medizone to pursue FDA 510(k) for AsepticSure

April 10, 2017 By Fink Densford

Medizone said last Friday after meeting with the FDA that it will pursue 510(k) clearance for its AsepticSure portable hospital disinfection system. The system is designed to be turned on from outside the room to be disinfected, enabling the machine to safely fill the room with a disinfecting gas formula. The device later clears the […]

Filed Under: Food & Drug Administration (FDA), Regulatory/Compliance, Sterilization / Calibration Tagged With: Medizone

Teleflex CEO Smith to step down | Personnel Moves | March 1, 2017

March 1, 2017 By Brad Perriello

Teleflex (NYSE:TFX) said this month that CEO Benson Smith will retire from the corner office by the end of this calendar year. Smith will continue to serve as the company’s chairman of the board. Liam Kelly, president & chief operating officer, was tapped to succeed Smith as CEO for the Wayne, Pa.-based company. “I want to […]

Filed Under: Business/Financial News Tagged With: Active Implants, Delcath Systems Inc., Glaukos, medical-metrics, Medizone, nda-partners, Novo Nordisk, Personnel Moves, SANUWAVE Health Inc., Teleflex, veracyte

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