Drugs and medical devices authorized, April 1 to June 30, 2026

Backgrounder

July 2026

From April 1 to June 30, 2026, Health Canada approved 15 new drug submissions (8 pharmaceuticals, 7 biologics) and 481 new medical devices, including 22 Class IV medical devices, which present the greatest potential risk. During this period, Health Canada also approved 31 generic drugs and 10 biosimilar drugs.

New and innovator drug approvals
Date Drug Purpose
June 26, 2026 Vimkunya Vaccine for Chikungunya
June 22, 2026 Boey Muscle relaxants
June 15, 2026 Exdensur Drugs for obstructive airway diseases
June 12, 2026 Pimjetmi Antineoplastic agents
June 10, 2026 Lupin-Glugacon Pancreatic hormones
June 3, 2026 Idvynso Antivirals for systemic use
May 29, 2026 Loargys Other alimentary tract and metabolism products
May 15, 2026 Thyconvi Thyroid therapy
May 14, 2026 Iheezo Ophthalmologicals
April 30, 2026 Kisunla Psychoanaleptics
April 16, 2026 Tevimbra Antineoplastic agents
April 10, 2026 Lunsumio SC Antineoplastic agents
April 10, 2026 Vueway Contrast media
April 9, 2026 Yeytuo Antivirals for systemic use
April 9, 2026 neffy Drugs for obstructive airway diseases
New Class IV medical device approvals
Date Medical Device Purpose
June 30, 2026 Visualase V2 MRI-guided laser ablation system Tool for neurosurgery
June 29. 2026 Epic Elite/Epic Supra G3 stented porcine tissue valve and sizers Replacement of heart valve
June 29, 2026 Alinity S CMV IGG qualitative assay Diagnostic and screening test kit for cytomegalovirus
June 24, 2026 SGTi-flex COVID-19 & flu A/B Ag Combo Point of care testing kit for COVID-19 and flu
June 10, 2026 cobas Respiratory flex Test to help in the diagnosis of respiratory infections
June 4, 2026 Seprafilm adhesion barrier For use in surgery to reduce internal organ adhesions
June 3, 2026 Affera ablation system Mapping and treatment of an abnormal heart beat
June 2, 2026 Shockwave intravascular lithotripsy (IVL) system with shockwave C2 aero coronary IVL catheter Treatment of heart disease
May 29, 2026 Jade plus PTA balloon dilatation catheter Treatment of heart disease
May 27, 2026 COVID-19 & Influenza A/B&RSV Antigen Pen Home Test Home testing kit for COVID-19, flu and RSV
May 26, 2026 Procleix Babesia Assay Test kit for screening blood, organ and tissue donors for Babesia
May 26, 2026 iVascular iCover, ballon expandable covered peripheral stent system Treatment of blood vessel diseases
May 26, 2026 cobas Microbial Inactivation Solution Preparation of testing specimens
May 26, 2026 Automated external defibrillator Automated external defibrillator for public use
May 6, 2026 Alinity i Anti-HCV Next Assay Test kit to help in diagnosis and donor screening for Hepatitis C
May 5, 2026 Simplexa COVID-19/flu A/B & RSV direct assay Testing kit to help in diagnosis of COVID-19, flu and RSV infections
May 4, 2026 iStatis Hepatitis B Surface Antigent (HBsAg) Test/iStatis Hepatitis B Surface Antigent (HBsAg) Test Controls Point of care test kit to help in diagnosis of Hepatitis B infections
April 27, 2026 NUVISION ultrasound catheter Imaging of heart or blood vessels
April 24, 2026 Supraflex sirolimus eluting stent system Treatment of heart disease
April 16, 2026 Scoreflex TRIO Balloon Dilatation Catheter Treatment of narrowing in heart arteries to improve blood flow
April 15, 2026 Cobas liat system Testing kit to help in diagnosis of COVID-19, flu and RSV infections
April 1, 2026 Volt PFA catheter, sensor enabled Treatment of heart disease

For more information on these and other drug and medical device approvals, consult:

  • The Drug Product Database, which contains product-specific information on drugs that have been approved for use in Canada such as their availability and product monograph.
  • The Medical Devices Active Licence Listing (MDALL) database, which contains the complete list of all medical devices that have been authorized for sale in Canada.
  • Medical devices in Canada are classified from Class I to Class IV based on the level of risk they pose. Class IV devices represent the highest-risk category and are subject to a rigorous pre-market review by Health Canada to ensure that they meet safety, effectiveness and quality requirements before they can be sold in Canada.

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2026-07-15