Titan Medical Appoints Tammy Carrea as VP, Quality and Regulatory Affairs

Titan Medical Inc., a medical device company focused on the design and development of surgical technologies for robotic single access surgery, has appointed Tammy Carrea as vice president of Quality and Regulatory Affairs.
 
“We are delighted that Tammy has joined Titan Medical’s leadership team as we advance our Enos robotic single access surgery system toward human clinical studies,” said David McNally, president and CEO. “Her proven track record in developing and implementing clinical and regulatory strategies, obtaining medical device regulatory clearances and successfully managing FDA inspections will be invaluable assets for Titan. It is my pleasure to welcome Tammy to Titan and I look forward to working with her as we progress toward submitting our application for Investigational Device Exemption for the Enos system to the FDA.”
 
Carrea has more than 25 years of experience in managing quality assurance and regulatory affairs activities in the medical device industry, including robotic assisted surgery. Carrea has been responsible for global submissions and registrations for Class 1, 2, and 3 medical devices including De Novo applications. Most recently, she served as vice president, Regulatory and Clinical Affairs and security officer of Translational Imaging Innovations Inc., which produced software for ophthalmology medical imaging and cloud data management to enable AI algorithm development.

Carrea earned a bachelor of science degree in materials science and engineering from North Carolina State University, and a master of science degree in quality and regulatory affairs from Temple University, with a concentration in medical devices and clinical research.
 
“I am thrilled to join Titan’s impressive leadership team during such a pivotal time in the company’s evolution. I look forward to applying my background and experience to help the company to realize its vision for commercializing its Enos robotic single access surgical system for the benefit of patients, while enhancing the surgical experience for surgeons and hospital staff,” said Carrea.
 
Curtis Jensen, Titan’s vice president of Quality and Regulatory Affairs since April 2017, left the company to pursue other opportunities in the medical device industry. “We thank Curtis for his contributions to the development program for the Enos system. Curtis commuted a long distance to Chapel Hill while the company established a team to advance the development of the Enos system. We wish Curtis the best in his future endeavors,” said McNally.
 
Titan Medical Inc., a medical device company headquartered in Toronto, Ontario, and with R&D facilities in Chapel Hill, N.C., is focused on enhancing robotic assisted surgery using technology through a single access point. The Enos robotic single access surgical system is being developed with an ergonomic focus to provide a surgical experience that imitates real-life movements that surgeons demand and includes multi-articulating instruments designed to allow surgeons an increased range of motion in a confined space, with dexterity and the ability to exert the forces necessary to complete common surgical tasks. With the Enos system, Titan intends to initially pursue gynecologic surgical indications.
 
Certain aspects of Titan’s robotic assisted surgical technologies and related intellectual property have been licensed to Medtronic plc, while retaining world-wide rights to commercialize the technologies for use with the Enos system.