Unbiased Analysis of Today's Healthcare Issues
In recent years, FDA has approved a number of pieces of software that use artificial intelligence (AI) under its medical device approval system. FDA approved only 5 AI-power medical devices in 2015, but approved 115 of these in 2021 and likely will approve even more in 2022. Which companies are the ones with the most…
The value of medical devices caries with it less certainty than pharmaceuticals for a variety of reasons. As described in Kovács et al. (2022) medical devices: often have multiple applications, frequently, undergo product modifications and during their product lifecycle, multiple incremental technological innovations take place affecting both clinical and economic consequences of their adoption into…
While we are waiting for the King v. Burwell verdict, which could repeal large sections of Obamacare, the house of representatives has already approved rolling back some ACA provisions. Modern Healthcare reports: Lawmakers postponed final passage of the proposed Protecting Seniors’ Access to Medicare Act despite a majority voting in favor of the bill. The…
The stethoscope has been the icon of medicine for 200 years. Shouldn’t we be able to have built a better device by now? In fact, an improved stethoscope exists. The Atlantic describes a new technology that combines a stethoscope and smartphone technology. The CardioSleeve, a new, FDA-approved accessory, transforms a standard analog stethoscope into a…
How do public payers set device reimbursement in the U.S. and Europe? A Health Affairs article by Sorenson, Drummond and Burns answers this question. Compared to the United States, Europe more formally and consistently considers value to determine which technologies to cover and at what price, especially for complex, costly devices. Both the United States and Europe have…