Steven Roy, CEO of Convergence Medical Sciences Inc., has designed a low-cost device that boosts the number of patients on a single ventilator to four simultaneously. To do this, he is collaborating with Calgary-based consulting engineers, Exergy Solutions Inc., to take the international Red Dot design winner through the Health Canada approval process.
TORONTO – Health Canada has proposed a single regulatory framework for medical device and drug clinical trials after broad industry consultation and a hard line drawn by the COVID-19 pandemic for a more streamlined system.
Adela snapped up $60 million in a series A financing round to commercialize its blood test for cancer detection and disease monitoring. At the same time, the company announced its name change from Dnamx Inc. The Adela system profiles all methylated DNA fragments in a blood sample, allowing it to determine the tissue of origin early in development of a malignancy and potentially simplifying screening across all cancer types.
TORONTO – Femtherapeutics Inc. is combining artificial intelligence-driven machine learning and 3D design to manufacture a device for relieving urinary incontinence and discomfort in women suffering pelvic organ prolapse. The custom-made pessary is intended to support vaginal tissues displaced because of the condition, replacing conventional pessaries that company officials said can result in irritation and penetrate soft tissues causing bleeding.
TORONTO – Titan Medical Inc. has received a $10 million license payment from Medtronic plc for a total of $30 million that the Irish med-tech firm has invested in robotic-assisted surgical technologies developed by Titan. Titan is pursuing gynecologic surgical applications for its Enos robotic single access surgical system, licensing it and related intellectual property to Medtronic while retaining worldwide rights to commercialize technologies for use with the Enos system.
Health Canada is proposing amendments to the Food and Drugs Act that would provide greater oversight of the manufacture of drugs for export. Currently, facilities that manufacture or prepare drugs in Canada for use outside the country are not required to obtain a drug establishment license or to follow Canadian requirements for good manufacturing practices, and they are exempt from fees.
Neovasc Inc. has hit pause on its Tiara transfemoral mitral valve replacement (TF) program and is cutting its workforce by more than 40%, citing the additional time and substantial investment required to develop the program and the associated costs. The changes are expected to extend its cash runway from about 18 months to more than three years. The changes were implemented with about 18 months to remain solvent as part of a series of actions to focus on enhancing current shareholder value and focusing investments on near-term value drivers, namely the Reducer stent and the Tiara transapical mitral valve replacement (TA) system.
The U.S. isn’t the only country tossing COVID-19 vaccines due to potential cross-contamination of the drug substances manufactured at an Emergent Biosolutions Inc. plant.
TORONTO – Nanology Labs Inc. has raised C$3 million (US$2.49 million) in seed funding to advance development of a polymer-lipid platform that transports nanoparticles into human cells where they “reprogram” hypoxic or oxygen-deprived cancer tumors.
Ortho Regenerative Technologies Inc. received a clinical hold letter from the FDA in connection with its investigational new drug (IND) application to begin a phase I/II trial for Ortho-R. The FDA asked for additional information on chemistry, manufacturing and control for the drug/biologic combination that the company is evaluating as an adjunct to rotator cuff repair surgery.
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