In light of the growing interest in the use of psilocybin, MDMA and other psychedelics in psychotherapy, Health Canada issued a notice spelling out how licensed providers can obtain the drugs through the agency’s special access program on a case-by-case basis.
A federal court cut off efforts Feb. 6 to halt a U.S. program allowing prescription drug imports from Canada before the program gets off the ground. The U.S. District Court for the District of Columbia dismissed a suit by the Pharmaceutical Research and Manufacturers of America (PhRMA) and other organizations, saying that they lacked standing because neither they nor their members face “a concrete risk of harm from the inchoate importation program.”
Venus Concept Inc. is undergoing a bit of nip and tuck in efforts to improve the company’s cash flow position and obtain long-term stability. As part of the reconfiguration, the company plans to shed 18% of its workforce with layoffs starting on Feb. 6. In Israel and North America. The executive leadership team also experienced some plumping and extraction.
Ottawa-based start-up Realize Medical Inc. reported U.S. FDA clearance of virtual reality (VR) surgical planning software to help physicians create and share complex patient anatomy from CTs and MRIs in an immersive 3D environment. Company CEO Justin Sutherland told BioWorld clearance of the Elucis platform “is a crucial milestone” that will benefit hospitals and his company well into the future.
Abk Biomedical Inc. has completed an oversubscribed $30 million series C funding round to support IDE approval for Eye90 microspheres designed to improve outcomes for patients with liver cancer. The departure point for the technology’s development is U.S. FDA-cleared Y90 technology such as Boston Scientific’s Therasphere and Sir-Spheres developed by Sydney, Australia-based Sirtex Medical Ltd. “They are the only radioembolization microspheres on the market and that is the clinical space in which we will be submitting our IDE application,” Abk chief business officer Gary Donofrio told BioWorld. “Hopefully we’ll get approvals for the pivotal study and eventually to market in that space. It’s going to be great to be able to innovate and improve on what’s already been done there.”
Cardiai Inc. has developed a small, portable monitor that continuously measures patients’ blood pressure (BP) at regular intervals for up to seven days, well beyond the single measurements historically done in a doctor’s office.
Irked by what state officials described as "bureaucratic roadblocks" to Florida's proposal for importing cheaper prescription drugs from Canada, Florida Gov. Ron DeSantis on Aug. 31 announced a state lawsuit against the U.S. FDA.
Health Canada approved a device which Wayne, Pa.-based Teleflex Inc. described as the first commercially available biomechanical vascular device designed to close large holes in the femoral artery during endovascular catheterization procedures.
Advanced manufacturing company Linamar Corp. has created Linamar Medtech to leverage its skills in precision manufacturing in the medical device and components space. The new venture, which will operate as a separate division under the Linamar umbrella, builds on recent programs producing a range of products, including ventilator systems and parts, part of the COVID-19 pandemic response.
As the COVID-19 pandemic slowly starts to ease globally, efforts are already gearing up to predict the next potential pandemic. One institute researching the increasing number of diseases transmitted from animals to humans is Canada’s Vaccine and Infectious Disease Organization, part of the University of Saskatchewan.
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