Globe Newswire04.10.19
BioSig Technologies Inc., a medical device company developing a proprietary biomedical signal processing platform designed to address an unmet technology need for the electrophysiology (EP) marketplace, has appointed a senior R&D engineer and is working on further senior biomedical engineering hires to support BioSig’s growing manufacturing processes and advanced R&D activities.
Fui Veavea brings to the company over 29 years of manufacturing and engineering experience in a range of medical device sectors, including implantable class III devices, diabetes-monitoring and respiratory diagnostic systems. During his career, Veavea acquired a wealth of knowledge in semiconductor, computer programming and validation and installation of sensors. He successfully led a number of product transfer and manufacturing processes and is highly experienced in regulatory matters, including quality design assurance and post-market surveillance. Veavea has earned various certifications, honors and awards, such as RAND Worldwide Certificate of Achievement to Pro-Engineer (2000).
“One of our internal goals for 2019 is the expansion of our engineering talents to augment the success and expansion we are seeing in other areas. Fui’s experience in a wide range of product development and quality control arenas is something that attracted BioSig. As we build on the primary goals with delivering high quality human data, we seek to increase internal talent to support our manufacturing processes during this important chapter in our Company’s development. We are confident that Fui will make a valuable addition to our team and look forward to his contributions,” commented Kenneth L. Londoner, chairman and CEO of BioSig Technologies.
In February, the company announced it successfully conducted the first patient cases using PURE EP System, its U.S. Food and Drug Administration (FDA)-approved proprietary signal acquisition and processing technology. The first commercial use of the System was completed at the Texas Cardiac Arrhythmia Institute in Austin, Texas, under the leadership of Andrea Natale, M.D., F.A.C.C., F.H.R.S., F.E.S.C., executive medical director, Texas Cardiac Arrhythmia Institute at St. David’s Medical Center. Early results of the studies suggested improved cardiac signal detection and fidelity.
The company also released its shareholder letter in February, where it stated its intentions to present the results from the First-in-Human studies and the early feedback from the use of the PURE EP System to a larger community of physicians during the Heart Rhythm Society event in May.
BioSig Technologies is a medical technology company developing a proprietary biomedical signal processing platform designed to improve the electrophysiology (EP) marketplace. Led by a management team and a veteran Board of Directors, BioSig Technologies is preparing to commercialize its PURE EP System. The technology has been developed to address an unmet need in a large and growing market. The PURE EP System is a novel cardiac signal acquisition and display system which is engineered to assist electrophysiologists in clinical decision-making during procedures to diagnose and treat patients with abnormal heart rates and rhythms. BioSig’s main goal is to deliver technology to improve upon catheter ablation treatments for the prevalent and potentially deadly arrhythmias, atrial fibrillation and ventricular tachycardia. BioSig has partnered with Minnetronix on technology development and has received FDA 510(k) clearance for the PURE EP System in August 2018.
Fui Veavea brings to the company over 29 years of manufacturing and engineering experience in a range of medical device sectors, including implantable class III devices, diabetes-monitoring and respiratory diagnostic systems. During his career, Veavea acquired a wealth of knowledge in semiconductor, computer programming and validation and installation of sensors. He successfully led a number of product transfer and manufacturing processes and is highly experienced in regulatory matters, including quality design assurance and post-market surveillance. Veavea has earned various certifications, honors and awards, such as RAND Worldwide Certificate of Achievement to Pro-Engineer (2000).
“One of our internal goals for 2019 is the expansion of our engineering talents to augment the success and expansion we are seeing in other areas. Fui’s experience in a wide range of product development and quality control arenas is something that attracted BioSig. As we build on the primary goals with delivering high quality human data, we seek to increase internal talent to support our manufacturing processes during this important chapter in our Company’s development. We are confident that Fui will make a valuable addition to our team and look forward to his contributions,” commented Kenneth L. Londoner, chairman and CEO of BioSig Technologies.
In February, the company announced it successfully conducted the first patient cases using PURE EP System, its U.S. Food and Drug Administration (FDA)-approved proprietary signal acquisition and processing technology. The first commercial use of the System was completed at the Texas Cardiac Arrhythmia Institute in Austin, Texas, under the leadership of Andrea Natale, M.D., F.A.C.C., F.H.R.S., F.E.S.C., executive medical director, Texas Cardiac Arrhythmia Institute at St. David’s Medical Center. Early results of the studies suggested improved cardiac signal detection and fidelity.
The company also released its shareholder letter in February, where it stated its intentions to present the results from the First-in-Human studies and the early feedback from the use of the PURE EP System to a larger community of physicians during the Heart Rhythm Society event in May.
BioSig Technologies is a medical technology company developing a proprietary biomedical signal processing platform designed to improve the electrophysiology (EP) marketplace. Led by a management team and a veteran Board of Directors, BioSig Technologies is preparing to commercialize its PURE EP System. The technology has been developed to address an unmet need in a large and growing market. The PURE EP System is a novel cardiac signal acquisition and display system which is engineered to assist electrophysiologists in clinical decision-making during procedures to diagnose and treat patients with abnormal heart rates and rhythms. BioSig’s main goal is to deliver technology to improve upon catheter ablation treatments for the prevalent and potentially deadly arrhythmias, atrial fibrillation and ventricular tachycardia. BioSig has partnered with Minnetronix on technology development and has received FDA 510(k) clearance for the PURE EP System in August 2018.