Guided Therapeutics (OTC:GTHP) said yesterday that China’s FDA has requested a small clinical trial of its LuViva line of cervical scan products. The Norcross, Ga.-based company said it received the request as a “new communication regarding regulatory approval of its LuViva line of products in China,” adding that it plans to submit final paperwork for approval […]
Guided Therapeutics pulls trigger on 1-for-800 reverse stock split
Guided Therapeutics (OTC:GTHP) said today that it pulled the trigger on a 1 for 800 reverse split of its stock, effective March 29. The Norcross, Ga.-based company said that its shareholders approved the reverse split last October. Through the deal, each shareholder of Guided Therapeutics will receive a single share of the company’s common stock for each […]
7 medtech stories we missed this week: April 6, 2018
From CHF Solutions’s distribution deal to Guided Therapeutics’s licensing agreement, here are seven medtech stories we missed this week but throught were still worth mentioning. 1. CHF inks Spanish distribution deal CHF Solutions announced in an April 5 press release that it has signed a distribution agreement with Dimedix Surgical. The distribution agreement will allow […]
7 medtech stories we missed this week: March 16, 2018
From Intricon expanding its manufacturing space to Arthrex signing a global distribution deal, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Intricon expands medical footprint Intricon announced in a March 13 press release that it has signed a 5-year lease that will secure 30,000 sq. ft of manufacturing […]
5 medtech stories we missed this week: Dec. 29, 2017
From NanoVibronix’s new Indian regulatory and distribution agreement to Guided Therapeutics’s Turkish distribution deal, here are five medtech stories we missed this week but thought were still worth mentioning. 1. NanoVibronix inks deal with Indian regulatory and distribution consultant NanoVibronix announced in a Dec. 20 press release that it has signed Morulaa HealthTech as its regulatory […]
Guided Therapeutics re-opens FDA discussions seeking LuViva PMA
Guided Therapeutics (OTC:GTHP) said today it re-entered discussions with the FDA about pursuing premarket approval for its LuViva advanced cervical scan device. The Norcross, Ga.-based company said the decision was prompted by “constructive” outcomes from previous meetings with the organization alongside a “perceived more favorable environment for device approvals under the new presidential administration” and a […]
Guided Therapeutics reveals details of $50m LuViva deal in China
Guided Therapeutics (OTC:GTHP) said that it inked an exclusive licensing agreement with Shandong Yaohua Medical Instrument Corp., to manufacture its LuViva advanced cervical scan system and related disposables. The deal also gives SMI exclusive distribution rights in China, Macau, Hong Kong and Taiwan. SMI is slated to pay a $1.0 million licensing fee in 5 installments until […]
Guided Therapeutics inks exclusive distro deal with Shandong Yaohua
Guided Therapeutics (OTC:GTHP) said last week it inked an exclusive distribution, sales and manufacturing rights deal for its LuViva advanced cervical scan system with Shandong Yaohua Medical Instrument Corp. Through the deal, Shandong Yaohua will retain exclusive distribution, sales and manufacturing rights in China, Taiwan, Hong Kong and Macau. The deal includes a $1 million licensing […]
Xtant Medical CEO Goldberger steps down | Personnel Moves | February 3, 2017
Xtant Medical (NYSE:XTNT) said that CEO Dan Goldberger resigned effective Jan. 21 “to pursue other interests.” The Belgrade, Mont.-based company, which was formed after Bacterin paid $86 million for spinal implant maker X-Spine Systems, said president Carl O’Connell will step in as interim CEO while the company’s board “contemplates the permanent CEO,” according to a […]
Guided Therapeutics inks Chinese Luviva licensing deal
Guided Therapeutics (OTC:GTHP) said today it inked a licensing deal with Shenghuo Medical to manufacture and market its LuViva advanced cervical scan system in China and several other Southeast Asian countries. The deal includes $200,000 in near-term cash payments, up to $1 million to support FDA approval for LuViva and extra support for achieving Chinese regulatory approval […]
Guided Therapeutics sees FDA path for LuViva cervical scanner
Guided Therapeutics (OTC:GTHP) said today that it believes it struck a “general agreement” for getting its LuViva cervical scanner approved by the FDA. The plan to collect more data on LuViva is slated to be completed over the next 2 to 3 months, Norcross, Ga.-based Guided Therapeutics said. The company said the agreement was hashed out at […]
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