Conavi and Japan Lifeline Announce MHLW Approval of Novasight Hybrid™ System for Japanese Market
Conavi Medical Inc. and Japan Lifeline are pleased to announce that they have received regulatory approval from the Ministry of Health, Labor and Welfare (MHLW) in Japan for the Novasight HybridTM intravascular imaging system.
“Until now, physicians in Japan have had to choose between IVUS or OCT when performing percutaneous coronary interventions (PCI).”, says Dr. Brian Courtney, CEO of Conavi. “We are delighted that Conavi and Japan Lifeline can now begin to offer both of these highly complementary imaging techniques on a single catheter to physicians in Japan.”
Novasight Hybrid™ System Receives Health Canada Approval
Conavi Medical Inc. is pleased to announce that it has received a Health Canada Medical Device License for the Novasight HybridTM System.
“Conavi is delighted to receive approval for the clinical use of the Novasight Hybrid System in Canada and are thankful to the many researchers, clinicians, patients, employees and other stakeholders that made this milestone possible”, says Dr. Brian Courtney, President and CEO of Conavi. “We are now able to offer this technology that combines the two most commonly used intravascular imaging modalities onto a single catheter to Canadian physicians, hospitals and their patients. Approval in Canada will also accelerate both our ability to pursue approvals in other countries and grow into an international provider of imaging devices.”
FedDev Ontario contributes over $3.9 million to help Conavi expand, capture global market and create over 60 skilled jobs
Yasmin Ratansi, Member of Parliament for Don Valley East, on behalf of the Honourable Navdeep Bains, Minister of Innovation, Science, Economic Development and Minister responsible for FedDev Ontario, announced a FedDev Ontario contribution of over $3.9 million for Conavi Medical Inc., a developer and manufacturer of leading-edge medical technologies, to support the expansion and reconfiguration of its production facility in Toronto.
FedDev Ontario’s contribution will allow Conavi Medical Inc. to expand its existing facility by 8,000 square feet, acquire advanced manufacturing equipment and software, and will position the company to be first-to-market globally. The company will create 61 new skilled full-time jobs.
Conavi Receives Late-Stage Innovation Grant from CMA
Conavi Medical is the recipient of the Late-Stage Innovation Grant from the Canadian Medical Association’s Joule Innovation Group. The Joule Innovation grant will give Conavi an opportunity to scale and solve medical challenges worldwide.
Japanese Sales Strategy of Novasight Hybrid™ System Announced
Conavi Medical is pleased to announce that Japan Lifeline has submitted an application for the regulatory approval of the Novasight HybridTM intravascular imaging system in Japan. In addition, Japan Lifeline will serve as the exclusive distributor of the Novasight Hybrid intravascular imaging system in Japan. Novasight Hybrid is the world’s first system to have been used clinically that is capable of providing both intravascular ultrasound (IVUS) and optical coherence tomography (OCT) on a single imaging catheter. Earlier this year, the Novasight Hybrid system received FDA 510(k) clearance in the United States and was featured by Conavi Medical at the TCT 2018 Interventional Cardiology conference.
First Clinical Use of Novasight Hybrid™ System
Conavi Medical is pleased to announce the first clinical use of the Novasight HybridTM System, which enables simultaneous imaging of coronary arteries with both intravascular ultrasound (IVUS) and Optical Coherence Tomography (OCT). IVUS or OCT are typically used by interventional cardiologists to image coronary anatomy during minimally invasive procedures, such as angiograms, angioplasty and stenting procedures. Drs. Tej Sheth and Natalia Pinilla Echeverri are co-investigators at Hamilton General Hospital where the procedures were performed under a Health Canada Investigational Testing Authorization.