IMDA eNews 032923
The latest news affecting you and your customers…
from the Independent Medical Specialty Dealers Association
TB cases approaching pre-pandemic levels
Early in the Covid-19 pandemic, tuberculosis rates dropped substantially, according to STAT. Data recently released by the Centers for Disease Control and Prevention, however, suggests TB is nearly back to pre-2020 levels. In the first year of the pandemic, the rate of TB cases fell to 2.2 per 100,000, rising to 2.4 per 100,000 in 2021. Last year, an estimated 8,300 cases of TB were reported due to an increase in cases among people newly arrived in the United States, as well as a higher incidence of cases among American Indians, Alaska Natives, Native Hawaiians and other Pacific Islanders, according to the report. There was a slightly lower incidence among people 65 and older, likely because so many in this age group have died from COVID.
Bill would enforce Medicare coverage of breakthrough devices
If passed, a newly introduced bill would require Medicare to cover new breakthrough medical devices for four years, according to Fierce Healthcare. The Ensuring Patient Access to Critical Breakthrough Products Act intends to close a gap between Food and Drug Administrations’ clearance of a breakthrough medical device and the Centers for Medicare & Medicaid Services’ decision to cover it for Medicare. The legislation comes as CMS is expected to issue a regulation later this year addressing coverage for breakthrough devices, which get a faster FDA review if they offer a better treatment of a life-threatening or debilitating disease. That said, it sometimes can take several years for such treatments to get Medicare coverage. The legislation would also extend temporary coverage for devices already approved as breakthrough products, such as digital therapeutics.
HHS ensures EUAs will remain in place for now
Health and Human Services Secretary Xavier Becerra has amended the February 2020 COVID-19 emergency use authorization declaration, according to the American Hospital Association. The amendment ensures the Food and Drug Administration’s emergency use authorizations for COVID-19 diagnostics, personal protective equipment, other medical devices, and drug and biological products will remain in effect until there is no longer a significant potential for a COVID-19 public health emergency, or the authorized devices or products have been approved. For more information, see the FDA’s EUA questions and answers.
Hydrocortisone reduces mortality in pneumonia patients
In a recent phase III randomized trial in France, intensive care patients with severe community-acquired pneumonia who were treated with hydrocortisone had a lower risk of death at 28 days compared with those who received a placebo, according to MedPage Today. Among the nearly 800 patients who received standard therapy, death occurred by day 28 in 6.2% of those in the hydrocortisone group compared with 11.9% of those in the placebo group. Results were consistent across subgroups.
Imaging tool improves burn wound assessment
Dallas, Texas-based SpectralMD is developing a new approach for burn wound assessment, according to Medical Device Network. SpectralMD is relying on AI and machine learning techniques to develop an imaging tool, the DeepView system, designed to accurately predict the severity of burn injuries. The image acquisition is said to take 0.2 seconds, and the output takes approximately 20 to 25 seconds. Using multi-spectral imaging, the system integrates AI algorithms and optical technology that can distinguish between healthy and damaged tissues. The imaging technology extracts clinical data, processes the image, and displays a comparison of the original image next to an image with a highlighted area of the non-healing portions of the wound.
Non-invasive imaging tool maps uterine contractions during labor
Researchers funded by the National Institutes
of Health have developed a new imaging tool, called electromyometrial
imaging (EMMI), to create real-time, three-dimensional images and maps of
contractions during labor, according to the NIH. The non-invasive imaging
technique integrates two types of non-invasive scans: a fast anatomical MRI to
obtain an image of the uterus, which can be taken during early term pregnancy,
and a multichannel surface scanning electromyogram, which uses sensors placed
along the belly to measure contractions during labor. The data is then combined
and processed into three-dimensional uterine maps.