Meet the New Medtronic

Medtronic is becoming a more compeititve and nimble organization under the leadership of Geoff Martha, who took over as CEO in April. Last week analysts and investors got a closer look at some of the structural changes that are intended to shift more resources and decision-making power to the operational level, enabling those businesses to compete more nimbly while still leveraging the breadth of a large company. In advance of the company's analyst day, MD+DI got a sneak peek at these changes in this exclusive interview.

The latest COVID-19 testing news

DOD Gets Behind Cue Health

After raising a sizable financing in June, Cue Health now has the support of a $481M award from the Department of Defense to expand production capacity of its COVID-19 test. The DOD investment will allow Cue Health to expand its U.S.-based production capacity and deploy 6 million molecular, point-of-care Cue COVID-19 tests by March 2021. Cue's cartridge-based COVID-19 molecular test is capable of producing results in about 20 minutes.

BD's New COVID-19 Test Assesses Immune Function

Becton Dickinson and Company (BD) has been awarded CE mark for a product that can assess immune function in COVID-19 patients. The Franklin Lakes, NJ-based company said the BD Multitest 6-Color TBNK Reagent with BD Trucount goes beyond the complete blood count and looks at the T-cell subtypes in COVID-19 patients. BD’s test has been used for years to assess immune function in HIV patients.

Abbott Continues Its Fast and Furious Pace with COVID-19 Tests

The company was awarded emergency use authorization for the AdviseDx SARS-CoV-2 IgM serology test. This makes the seventh test Abbott has received EUA for since the pandemic began. The impetus behind the new test is to give a more complete picture of where patients are in the recovery process. Abbott said data about the AdviseDx serology diagnostic shows test results with 99.6% specificity and 95% sensitivity for patients tested 15 days after symptom onset.

And in case you missed our most recent Medtech in a Minute articles ...

Diversity Takes Center Stage in Medtech

Speakers at AdvaMed’s Virtual MedTech Conference did not shy away from the subject of racial injustice, and at least one CEO encouraged his peers to “stand up for what is right.” The conference also addressed health disparities and diversity needs within the industry itself. AdvaMed also incorporated diversity topics into the program in a variety of ways, including a podcast featuring Kwame Ulmer, a FDA veteran and founder of MedTech Color. Recently, Boston Scientific unveiled its plan to take on systemic racism in healthcare through its Close the Gap initiative.

FDA Leans on Data

FDA Commissioner Stephen Hahn told AdvaMed’s President and CEO Scott Whitaker during the Virtual Medtech Conference that FDA’s scientists have made decisions about medical products throughout the pandemic and will continue to do so. Hahn became commissioner in December 2019, shortly before the COVID-19 outbreak spread to the United States and was declared a global pandemic. AdvaMed CEO Scott Whitaker asked Hahn about FDA’s vaccine approval process, pointing out that “some people are raising questions and skepticism about whether career scientists are still in charge.” Hahn sought to shoot down that skepticism. “Let me just be clear up front—our career scientists throughout this pandemic have made decisions about medical products and will continue to make those decisions,” he said.

Illumina and Grail Want to Reunite

The rumors are indeed true – Illumina is attempting to acquire early cancer detection specialist Grail for about $8 billion. Grail was spun off from Illumina in 2016. The proposed acquisition comes hot on the heels of Grail announcing it was seeking to go public.