Corindus Vascular Robotics has recorded the first in-human cases of remote percutaneous coronary intervention with the CorPath robotic surgical platform. The procedures were performed on five patients in India from a location about 20 miles away.
A positive coverage policy has been issued by Blue Cross Blue Shield of Arizona for minimally invasive surgical sacroiliac joint fusion using SI-BONE's iFuse Implant System.
A study in the Blood Cancer Journal found three genetic alterations are associated with a two to three times higher risk of developing multiple myeloma for African-Americans. The findings were based on an analysis of data from samples from 881 people in the Mayo Clinic Genomics Laboratory.
Researchers demonstrated improved engraftment in adults receiving umbilical cord blood-derived stem cells using nicotinamide-based ex vivo expansion technology. They achieved a 94% rate of graft success after six weeks for adults with blood cancer, according to a Phase I/II study in the Journal of Clinical Oncology. "Although umbilical cord blood transplantation has been used for 30 years, expansion technology represents an opportunity to improve the results for adult patients," lead author Dr. Mitchell Horwitz of Duke University said.
Amgen, the Fred Hutchinson Cancer Research Center and Poseida Therapeutics presented oral abstracts at the American Society of Hematology annual meeting on bispecific antibody and anti-B-cell maturation antigen candidates.
Sam Meenasian outlines strategies for social success, including adopting a storytelling approach, using chatbots on platforms like Facebook Messenger and consistently creating interesting and engaging content to boost organic reach. Facebook's algorithm changes have made it harder but marketers must be more creative to reach audiences on the most dominant platform and employ ephemeral content on Instagram and Snapchat to appeal to younger consumers, he advises.
The FDA accepted under priority review status Genentech's supplemental biologics license application for Tecentriq, or atezolizumab, in combination with carboplatin and etoposide chemotherapy, to treat patients with extensive-stage small cell lung cancer in a first-line setting. The agency is anticipated to make a decision by March 18.
The FDA has approved removal of a safety warning on the label of Smith & Nephew's Regranex gel that noted "increased rate of mortality secondary to malignancy." The decision came after several studies showed no increased safety risk from Regranex, which is indicated to treat lower extremity diabetic neuropathic ulcers.
Advanced medical technologies and data analytics are needed to address the opioid crisis, note Jeffrey Shuren, director of the Center for Devices and Radiological Health, and Jonathan Jarow, chief medical officer of CDRH's Office of Device Evaluation. "We believe the greatest opportunities for medical devices to help prevent opioid use disorder are devices that could help identify people likely to become addicted, devices that manage pain as an alternative to opioids or reduce the need for opioid medications," they write in a blog post.
While the rate of approvals under the Medicare new technology add-on payment program has improved, the payment rates for products are too low and should be raised from 50% to 80% of the additional cost above the payment rate for a diagnostic-related group, AdvaMed Senior Vice President for Payment and Health Care Delivery Policy Richard Price said at the NTAP annual meeting. Price added that the CMS should prohibit the practice of some Medicare administrative contractors to deny coverage of NTAP-designated devices, as well as streamline the process for products that receive breakthrough status.