The FDA is revamping their medical device clearance process after a week of none-too-flattering press coverage related to med device issues. The current process for med device approval can be accelerated if companies demonstrate their product is substantially equivalent to already approved products. Trouble is that technology evolves every once in a while (in infographic form here), so the new process puts a ten-year limit on using a reference product. The agency is pursuing these changes after stories like this which allege that medical devices have caused 80,000+ deaths since 2008. Other stories included ‘export-only’ devices made in the US without FDA approval causing injuries abroad, and Health Canada changing their clearance process after similar criticisms. Looks like a change is gonna come. Here are 2018’s 10 most innovative medical devices.
Put on some Snoop Dogg (do we even have to say NSFW) and your favorite Bob Marley shirt, Canada is now the world’s largest legal marijuana market. Canada is the second country in the world behind Uruguay to legalize recreational use of cannabis, but unlike Uruguay, it won’t have to deal with the financial restrictions of using US dollars to sell the stuff. The safe regulatory environment means Canada will likely turn into the world’s center for agricultural research into the plant, on everything from increasing the potency of its compounds, to the genetic sequencing of its different varieties like “CBD God Bud” and “Cold Creek Kush.” If you want to get in on the reefer madness and make the trip up to the Great White North for some weed tourism, just make sure you do your own research beforehand.
Chalk one up for the Canadians, eh. Bob & Doug McKenzie would be so proud. Researchers from the Montreal Neurological Institute of McGill University and the Ludmer Centre for Neuroinformatics recently published, in NeuroImage, a paper that introduces and validates the concept of the personalized Therapeutic Intervention Fingerprint (pTIF), which predicts the effectiveness of potential interventions for controlling a patient’s disease evolution. Think personalized medicine from a brain perspective. Using pTIF subtypes, drugs can be designed for a patient’s unique gene expression profile and phenotypic brain characteristics, which is a major advancement in personalized medicine. For some cool images go here. Their first focus is on Alzheimer’s disease patients. So, don’t be a hoser, stop watching anti-drug commercials, and enjoy the McKenzie’s 12 Days of Christmas song.
If you’re one of the estimated 60 million Americans who fill out a NCAA basketball bracket each year, then this story will resonate with you. But, you’re about to feel much worse about your health system. The New York Times decided to play bracketology with the health systems from Canada, Britain, Singapore, Germany, Switzerland, France, Australia and the U.S. by having five experts pick which system was better in head-to-head match-ups, with the winner advancing. In the end, Switzerland won, with Germany as a close second. France defeated the US in round two by a 3-2 vote. This writer is quick to acknowledge there are many different lenses through which a system can be evaluated. InsightCity readers, what do you say? Bring on the comments.
If you don’t get that reference, you’re doing TV / life wrong. A report from The Globe and Mail states that Canada’s federal government is considering action against U.S.-based Purdue Pharma over “potentially illegal activities in the marketing of OxyContin in Canada.” InsightCity covered instances of U.S. states going after Purdue (see Ohio and Washington), but a neighboring country’s federal government getting involved means the trouble is far from over. In 2007, Purdue paid out $634.5 million in the U.S. to settle similar charges, and the Canadian government wants a similar outcome for their opioid crisis dating back 21 years. As in Westeros, there’s a situation brewing with the neighbors in The North. New episode of Thrones this Sunday at 9pm…HBO, give me free stuff.