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Cervical Device Articles & Analysis

14 news found

Guided Therapeutics Announces Testing Completion of First 150 Patients in Chinese Clinical Study and Receives Milestone Payment of $177,740

Guided Therapeutics Announces Testing Completion of First 150 Patients in Chinese Clinical Study and Receives Milestone Payment of $177,740

The Company’s first product is the LuViva® Advanced Cervical Scan, a non-invasive device used to detect cervical disease instantly and at the point of care. In a multi-center clinical trial with women at risk for cervical disease, the technology was able to detect cervical cancer up to two years earlier ...

ByGuided Therapeutics, Inc.


Cervision™ - First International Sales Launch in Brazil

Cervision™ - First International Sales Launch in Brazil

Spinologics Inc. and Importek have announced today the launch of Cervision™, an upper-extremity patient positioning device for cervical spine surgery, in Brazil. This launch marks the first international sales development of this product since its domestic introduction. ...

BySpinologics Inc


Guided Therapeutics Announces Start of Chinese Clinical Trial for Approval to Market and Sell LuViva in China

Guided Therapeutics Announces Start of Chinese Clinical Trial for Approval to Market and Sell LuViva in China

China has a population of approximately 560 million women above 15 years of age, who are at risk of developing cervical cancer. Current estimates indicate approximately 100,000 new cases of cervical cancer are diagnosed each year and 30,000 deaths occur annually due to cervical cancer in China. ...

ByGuided Therapeutics, Inc.


Guided Therapeutics Ships LuViva Devices to China for Start of Clinical Trial; Receives Additional $100,000 Payment

Guided Therapeutics Ships LuViva Devices to China for Start of Clinical Trial; Receives Additional $100,000 Payment

(OTCQB: GTHP), the maker of the LuViva Advanced Cervical Scan, based on its patented biophotonic technology, announced today that its Chinese partner, Shandong Yaohua Medical Instrument Corporation (SMI), had received ethics board approval and placed LuViva devices at two of the three participating hospitals for clinical trials aimed at achieving Chinese FDA ...

ByGuided Therapeutics, Inc.


Guided Therapeutics Receives Notification of Successful Clinical Trial Regulatory Review and $133,000 Payment from China

Guided Therapeutics Receives Notification of Successful Clinical Trial Regulatory Review and $133,000 Payment from China

China has a population of approximately 560 million women above 15 years of age, who are at risk of developing cervical cancer. Current estimates indicate approximately 100,000 new cases of cervical cancer are diagnosed each year and 30,000 deaths occur annually due to cervical cancer in China. ...

ByGuided Therapeutics, Inc.


New European Published Study Shows LuViva Detects 20% More Precancerous and Cancerous Cervical Disease than HPV Test

New European Published Study Shows LuViva Detects 20% More Precancerous and Cancerous Cervical Disease than HPV Test

(OTCQB: GTHP), the maker of the LuViva Advanced Cervical Scan, based on its patented biophotonic technology, announced today that an independent study of 166 women in Hungary showed that LuViva detected 20% more cervical precancer and cancer than the HPV test. ...

ByGuided Therapeutics, Inc.


Guided Therapeutics Receives News from Chinese State Food and Drug Administration that LuViva Meets Product Technical Requirements

Guided Therapeutics Receives News from Chinese State Food and Drug Administration that LuViva Meets Product Technical Requirements

(OTCQB: GTHP), the maker of the LuViva™ Advanced Cervical Scan, based on its patented biophotonic technology, announced today its Chinese co-manufacturing partner and distributor for China, Shandong Yaohua Medical Instrument Corporation (SMI), has received notice from the Jinan Medical Device Quality Supervision and Testing Center of the State Food and Drug ...

ByGuided Therapeutics, Inc.


Guided Therapeutics Replaces Convertible Note Facility and Significantly Reduces Dilution

Guided Therapeutics Replaces Convertible Note Facility and Significantly Reduces Dilution

The Company’s first product is the LuViva® Advanced Cervical Scan, a non-invasive device used to detect cervical disease instantly and at the point of care. In a multi-center clinical trial with women at risk for cervical disease, the technology was able to detect cervical cancer up to two years earlier ...

ByGuided Therapeutics, Inc.


Guided Therapeutics Closes $2.114 Million Series F Preferred Stock Financing

Guided Therapeutics Closes $2.114 Million Series F Preferred Stock Financing

The Company’s first product is the LuViva® Advanced Cervical Scan, a non-invasive device used to detect cervical disease instantly and at the point of care. In a multi-center clinical trial with women at risk for cervical disease, the technology was able to detect cervical cancer up to two years earlier ...

ByGuided Therapeutics, Inc.


Guided Therapeutics Raises US $1.1 Million in New Preferred Stock Offering

Guided Therapeutics Raises US $1.1 Million in New Preferred Stock Offering

The Company’s first product is the LuViva® Advanced Cervical Scan, a non-invasive device used to detect cervical disease instantly and at the point of care. In a multi-center clinical trial with women at risk for cervical disease, the technology was able to detect cervical cancer up to two years earlier ...

ByGuided Therapeutics, Inc.


DxNow, Inc. Receives FDA 510(k) Clearance for ZyMot ICSI and ZyMot Multi Sperm Separation Devices

DxNow, Inc. Receives FDA 510(k) Clearance for ZyMot ICSI and ZyMot Multi Sperm Separation Devices

DxNow, Inc., a privately held medical device company, announces receipt of FDA 510(k) clearance of its ZyMot™ ICSI and ZyMot™ Multi Sperm Separation Devices. ...

ByZyMōt Fertility, Inc.


Guided Therapeutics Ships First Four LuViva Advanced Cervical Scans for $14 million Turkish Ministry of Health Order

Guided Therapeutics Ships First Four LuViva Advanced Cervical Scans for $14 million Turkish Ministry of Health Order

The device is used in conjunction with the LuViva® Cervical Guide single-use patient interface and calibration disposable. ...

ByGuided Therapeutics, Inc.


Guided Therapeutics and U.S. FDA Agree on Meeting Date to Plan Path Forward for LuViva Advanced Cervical Scan Premarket Approval Application

Guided Therapeutics and U.S. FDA Agree on Meeting Date to Plan Path Forward for LuViva Advanced Cervical Scan Premarket Approval Application

The device is used in conjunction with the LuViva® Cervical Guide single-use patient interface and calibration disposable. ...

ByGuided Therapeutics, Inc.


Guided Therapeutics Turkish Distributor Doubles Order for LuViva Advanced Cervical Scan Single-Use Disposables for Turkish Ministry of Health

Guided Therapeutics Turkish Distributor Doubles Order for LuViva Advanced Cervical Scan Single-Use Disposables for Turkish Ministry of Health

The device is used in conjunction with the LuViva® Cervical Guide single-use patient interface and calibration disposable. ...

ByGuided Therapeutics, Inc.

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