Milestones

Jun 2017

QED 2000 China CFDA Clearance.

Mar 2017

BPG 8000 China CFDA Clearance.

Mar 2017

Development and production of animal ECG.

Dec 2016

BPG 8000 CE Clearance.

Aug 2016

QED 2000 US FDA 510k Clearance.

Jan 2016

Received US Patent #9,226,676.

Sep 2015

Development and production of BPG 8000 Blood Pressure Monitor with AFIB detection.

May 2015

QED 2000 TFDA Clearance.

Apr 2015

Passed IEC 60601-2-25: 2011 requirement.

Jan 2015

QED 2000 GMP Certification.

Jan 2015

QED 2000 CE Certificate Clearance.

2014

Finished Clinical Trials Stage IV in CHI-MEI Taiwan Hospital.

Nov 2014

Passed IEC 60601-2-27: 2011 requirement.

Apr 2014

Established ISO 13485 and GMP quality assurance system.

Mar 2014

Received Taiwan Patent #I435708.

Jan 2014

Received US Patent #8,626,274.

Oct 2013

Development and production of QED 2000 ECG monitor.

2012

Completed Clinical Trial Stage III at University of California, San Francisco.

Jan 2011

Establishment of ACME Dynacardia division for medical equipment manufacturing and sales.

Jan 2011

Received US Patent #7,869,864.

Jan 2010

QED 1000 FDA 510k clearance.

2010

Completed Clinical Trial Stage II at State University of New York, Buffalo.

Oct 2009

Official partnership with Dynacardia company.

2008

Finished Clinical Trials I in Taiwan.

Oct 2007

Development and production of QED 1000 electrocardiogram (ECG) monitor.

Feb 2007

Began R&D for myocardial ischemia validation software.