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HMicro Inc. Announces Kim Tompkins as Vice President of Regulatory & Clinical Affairs
9/18/2013 8:46:37 AM
LOS ALTOS, CA – HMicro Inc. (“HMicro”) a company focused on designing and developing disposable wireless patches for measuring and monitoring vital signs for health and wellness is pleased to announce the appointment of Ms. Kim Tompkins as the company’s Vice President of Regulatory and Clinical Affairs. The addition of Ms. Tompkins, with over 25 years of healthcare experience and an established track record in regulatory affairs, further prepares HMicro as the company begins the 510(k) approval process for the company’s lead product, a REACH™ wireless semiconductor platform based medical device.
Ms. Tompkins was also Vice President, Regulatory and Clinical Affairs for Bioness, Inc., a manufacturer of neuromodulation technologies. While there, Ms. Tompkins was responsible for clinical strategy, scientific design, implementation and enrollment. On the regulatory front, Ms. Tompkins managed all aspects of regulatory strategy, submissions and compliance. Her key accomplishments included: attaining device 510(k)’s approval for five products, obtaining an IDE approved in 30 days, and implementing and managing a US multi-center IRB-approved clinical trial.
Previously, Ms. Tompkins was Vice President, Clinical/Regulatory and Corporate Compliance Officer for Teleflex/VasoNova, Inc., a company specializing in the development of an intravascular navigation device. There she was responsible for clinical strategy, scientific design, implementation and completion. Her talent in areas of regulatory strategy, submissions and compliance resulted in her obtaining five device 510(k)’s for corporate products.
Lending her expertise to a variety of device-related companies, Ms. Tomkins was President of Tompkins Consultants. Her firm offered consultation in regulatory, clinical and quality systems for companies in the medical device industry.
Ms. Tompkins started her career in clinical research at DePuy, a manufacturer and distributor of Class II/III orthopedic devices. She was responsible for study management of FDA-approved and other clinical studies through all phases and interfaced with FDA on five studies.
Ms. Tompkins is a registered nurse, has a Masters in Business Administration, authored various medical-related articles, received several awards highlighting her work, and is affiliated with key medical-oriented organizations recognizing her accomplishments in the area of medical devices.
Commenting on Ms. Tompkins’ appointment, HMicro’s President and CEO, Dr. Surendar Magar stated, "Given Kim’s extensive experience across the healthcare industry as well as with emerging medical device companies, the Board of Directors and I are delighted that she has joined the HMicro team. Her well tested talents will be put to use immediately as HMicro begins the 510(k) submission related work for the company’s wireless medical products. Given the growing demand for wireless monitoring and the many healthcare applications the REACH™ platform serves, having the official 510(k) approval will allow HMicro to launch a series of game changer wireless medical products.”
“I appreciate the opportunity to be joining HMicro at this pivotal time in the company’s history. I am excited about HMicro’s industry leading REACH™ platform which, for the first time, enables a variety of fully disposable wireless patches to displace current wired sensors – a paradigm shift in healthcare. I look forward to managing company’s regulatory and clinical aspects to help HMicro to successfully complete its final critical phase – FDA approvals.” stated Kim Tompkins.
HMicro Inc. is the first mover in disposable wireless patches eliminating all wires for vital signs monitoring. The Company’s solution replaces the disposable sensors, leads and cables used in current “wired” monitoring systems with fully disposable wireless patches while seamlessly integrating with existing monitoring equipment with initial focus on the ECG market. HMicro will sell products to hospitals, clinics, etc., through established distributors, as well as to selected OEMs of healthcare products. For more information, please visit www.hmicro.com.
4984 El Camino Real, Suite 200
Los Altos, CA, United States
Jennifer K. Zimmons, Ph.D.
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