It’s going to get much more expensive to market medical devices in Canada. Health Canada recently said that makers of Class II, III and IV devices will have to pay 75% of its costs for pre-market evaluations, 67% of right-to-sell application costs and 100% for establishment licenses. That’s up from the 43% regulatory costs the […]
Health Canada
Canada bans Allergan Biocell breast implants
Health Canada has suspended sales of Allergan’s Biocell breast implants due to a higher incidence of a rare breast cancer in patients with macro-textured breast implants than other implants. The Allergan (NYSE: AGN) Biocell breast implants are the only macro-textured implants available in Canada. The regulatory agency instituted the ban based on the results of a 2017 safety […]
7 medtech stories we missed this week: March 3, 2017
Several clinical study results were published this week, while other companies reached distribution deals. Here are 7 medtech stories we missed this week but were still worth mentioning. 1. Health Canada approves Ventripoint’s complete heart analysis system for 2D ultrasounds Ventripoint Diagnostics received a license from Health Canada for its new VMS-Plus machine and the 4-chamber […]
Medtronic secures Health Canada license for MiniMed 630G system
Medtronic (NYSE:MDT) subsidiary Medtronic Canada said today that it landed a license with Health Canada for its MiniMed 630G system with SmartGuard tech for patients with diabetes mellitus. The Fridley, Minn.-based company said it interviewed more than 1,000 diabetes patients to better understand the features they look for in an insulin pump. The final product has […]
Baxter wins Health Canada nod for Amia peritoneal dialysis system
Baxter (NYSE:BAX) said today that it won a nod north of the border for its Amia automated peritoneal dialysis system. The Health Canada approval makes Amia the 1st automated peritoneal dialysis device cleared in the U.S. and Canada that includes voice guidance, touchscreen control and 2-way telemedicine features, Deerfield Park, Ill.-based Baxter said. “As a leader in home […]
AngioDynamics wins Health Canada nod for new Celerity device
AngioDynamics (NSDQ:ANGO) said today that it won approval from Health Canada for its Celerity with Navigation tip location system for peripherally inserted central catheters. Latham, N.Y.-based AngioDynamics won approval north of the border for the 1st Celerity iteration back in September 2013. The new version is designed to allow real-time catheter tracking, the company said. “This is […]
Glaukos iStent wins nod from Health Canada
Glaukos (NYSE:GKOS) said today it won approval from Health Canada for its iStent Inject trabecular micro-bypass stent designed for use in cataract surgeries to treat glaucoma. The newly cleared iStent inject is indicated for micro-invasive glaucoma surgery procedures to reduce intraocular pressure in patients with primary open-angle glaucoma, pseudoexfoliative glaucoma or pigmentary glaucoma, the Laguna Hills, […]
Sorin’s Perceval heart valve wins Health Canada nod
Sorin Group (BIT:SRN) said today that it won approval from Health Canada for its Perceval sutureless aortic valve replacement. The valve, which is designed to hold itself in place with a self-anchoring frame, is under review at the FDA now that Sorin has a U.S. investigational device exemption trial under its belt, the company said. “Sorin is […]