False negatives increase the risk that patients will not self-isolate or exercise other precautions — such as wearing a mask — and make more people sick than if they had had an accurate diagnosis.
Abbott Laboratories received FDA clearance for its newest continuous glucose monitor, the FreeStyle Libre 2. The product is one of many in a growing market for CGMs.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
Bigfoot Biomedical plans to submit an application to the FDA for clearance of its smart insulin pen caps this month. The devices pull in information from a connected glucose monitor to help users calculate the optimal insulin with each meal.
Abbott struck a deal with Bigfoot Medical by which the latter will use Abbott's glucose sensing technology to develop an artificial pancreas and not that of DexCom, the CGM market leader.
Abbott Labs (ABT) announced it received FDA approval for MitraClip, a less-invasive mitral valve repair technology. The device allows physicians to repair the mitral valve using a catheter rather than open heart surgery for patients with mitral regurgitation. The company will launch the product in the U.S. immediately. While open heart mitral valve surgery is […]
Off-label promotion is apparently second nature to healthcare companies. Even despite the fact that it is illegal. Now, there may be a powerful deterrent and a signal that the federal government is cracking down on the practice more strongly than before. Last year, the federal government collected $1.45 billion in a settlement from pharmaceutical and […]
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.