Senseonics Holdings Inc. is one of the latest med-tech companies to release its quarterly numbers, revealing sales of $261,000, a decline of -94.3% year-over-year. That figure may have fallen below SVB Leerink Research’s estimate of $1.6 million and consensus at $1.4 million “given the company's well-telegraphed ongoing strategic review,” wrote Danielle Antalffy in a note. Still, Senseonics had some good news, which Antalffy heralded as “very positive.” That came in the form of a financial and strategic partnership with Ascensia Diabetes Care that revolves around a global commercialization and distribution agreement and a concurrent financing deal.

The Medical Device Innovation Consortium (MDIC) has worked diligently to stand up the National Evaluation System for health Technologies (NEST) as a functioning program, and the first iteration, known of course as NEST 1.0, is now up and running.

“There’s a difference in knowing something and realizing something. We’ve known for quite a while now that we’re too dependent on other countries for our medical supplies. But during this pandemic, I think we’ve realized it,” U.S. Rep. Buddy Carter (R-Ga.) said at a recent congressional hearing on the progress being made in developing COVID-19 vaccines.

The annual publication of the draft Medicare physician fee schedule (MPFS) is an event, but this year’s draft has drawn substantial criticism from across the board, despite the promise of more coverage of telehealth. The Medical Imaging & Technology Association (MITA) and a coalition of surgeons have blasted the draft as a hazard to patient access to both evaluation and management (E/M) services and surgical procedures, both of which present substantial headwinds for the medical device industry.

“There’s a difference in knowing something and realizing something. We’ve known for quite a while now that we’re too dependent on other countries for our medical supplies. But during this pandemic, I think we’ve realized it,” U.S. Rep. Buddy Carter (R-Ga.) said at a recent congressional hearing on the progress being made in developing COVID-19 vaccines.

Neura Inc., which focuses on AI-powered behavioral intelligence that provides real-world insights for health organizations, governments and consumer brands, has revealed the adoption of its Viruscore COVID-19 predictive testing solution.

The COVID-19 pandemic has sparked some innovation in testing, but not all that innovation has made it to market. Michael Mina, an assistant professor of epidemiology at the Chan School of Public Health at Harvard University, said on an Aug. 7 conference call that the U.S. FDA’s “archaic view” of testing is impeding the use of paper strip tests he said would turn the tide in the effort to contain the pandemic.

Real-world evidence (RWE) and clinical trial data might seem to bear little resemblance to each other, but Naomi Aronson, executive director for clinical evaluation at the Blue Cross and Blue Shield Association, said there are problems common to both. The most significant of these is an absence of validated outcomes measures for many conditions, measures Aronson said are “desperately” needed in order to make an appropriate coverage determination.

With the economy and public health on the line, U.S. President Donald Trump thumped his Made in America pulpit again Thursday on a campaign swing through Ohio, in which he vowed to bring the pharmaceutical supply chain home over the next four years.