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.
In a blow to more established hearing aid producers, the audio magicians at Bose have been FDA approved to market the Bose Hearing Aid to consumers. The news sent shares sliding for traditional manufacturers like William Demant and Sonova Holding AG. It’s the first hearing aid that patients can fit and control themselves through the use of a smartphone app. That’s great news for Grandpa—who now doesn’t need to go to the doctor to adjust his volume levels—as well as for your kids who get to see Grandpa way more since you’re now the one who has to adjust his volume levels. Clinical data shows that patient outcomes were comparable between self-fitted and professionally-fitted devices, so expect more self-fitted aids in the future. We’re looking at you Samsung.
When you’re talking about medical device cybersecurity, of course. According to a recent study by Deloitte, more than 35% of professionals in the Internet of Things-connected medical device ecosystem say their organizations have experienced a cybersecurity incident in the past year. What the #&%$ is an “incident?” Want to hear something scary? Of course you do. 27% of respondents indicated they “don’t know.” So, when you do the math, it means 45% of respondents who had knowledge, indicated they had an incident. Stupid math. So, we have that going for us, which is nice. In researching this article, we found a statement you might find amusing: “A little over one-third of respondents (30.1%) stated….” Nope.
The current process we use for determining the boundary between cancerous and healthy cells during surgery—frozen section procedure—has been around for over 100 years. Let that sink in. While we’re sure there have been vast improvements in optimizing the procedure in the past century, it still takes about 30 minutes to prepare and analyze a section. That’s a lot of extra time to stay under for surgery. Well researchers at The University of Texas at Austin decided they wanted to make that time faster—about 150 times faster. Their device, the MasSpec Pen, is reportedly able to make the analysis within 10 seconds, is more accurate than FSP, and allows for more precision during tissue removal. Nice work, Longhorns.
People with Type 1 diabetes could soon be saying goodbye to sticking their fingers to check blood sugar levels. This news comes from a study among children with Type 1 diabetes conducted by the University of Virginia, that tested how well an artificial pancreas developed by the school performed at managing insulin and glucose levels against the patient’s home routine. The platform, which is controlled using a smartphone, uses algorithms that wirelessly link to a blood-sugar monitor and insulin pump worn by the patient, as well as to a remote-monitoring site. The children using the device averaged more time within the target blood-sugar range without an increase in hypoglycemia than those without. Also, probably no need to worry about getting kids to check their phones.