The question of whether the U.S. FDA will review emergency use authorizations (EUAs) for lab-developed tests (LDTs) for the COVID-19 pandemic has bounced around frequently in recent weeks, and Brett Giroir of the Department of Health and Human Services has resurrected the issue.

Boston Scientific Corp. said it is initiating a global, voluntary recall of all unused inventory of the Lotus Edge aortic valve system, blaming complexities associated with the product delivery system. The Marlborough, Mass.-based company emphasized that the valve itself continues to achieve positive and clinically effective performance post-implant. However, because of the time and investment needed to develop and reintroduce a delivery system, the company believes it is necessary to retire the entire Lotus platform immediately.

Boston Scientific Corp. reported that it has initiated the nationwide U.S. launch of Spaceoar Vue Hydrogel, a radiopaque version of Spaceoar Hydrogel that enables the use of computerized tomography scans instead of requiring magnetic resonance imaging (MRI) for patients undergoing radiation for prostate cancer.

Most of a pancreatic tumor is not made up of tumor cells – a double-edged sword for the tumor cells. This connective tissue component impedes blood flow, which is part of what makes pancreatic cancer so drug-resistant. But the lack of blood also means a lack of oxygen and nutrients, so pancreatic tumors must find alternate ways to feed themselves. That’s where nerves come in. In the Nov. 2, 2020, online issue of Cell, researchers published new insights into how innervation feeds tumors, and how to stop them from doing so.

Qiagen NV has started U.S. commercialization of a portable SARS-CoV-2 antigen testing device that can analyze up to 30 patient samples an hour. The Qiareach test features a portable hub device – smaller than a laptop – that can hold up to eight nasopharyngeal swab samples at a time. The test provides a digital readout of the results in two to 15 minutes – with strong positive results taking closer to two minutes and negative results coming back in 15 minutes.

Acutus Medical Inc. posted strong results for the third quarter of 2020, despite the ongoing uncertainties of the COVID-19 pandemic. Sales for the quarter totaled $3.2 million, up 180% sequentially and 391% when compared with the same period in 2019.

Regulation of the digital health space is in some respects fundamentally different from traditional hardware medical devices, a fact that was highlighted during a Nov. 12 webinar hosted by the U.S. FDA. Nonetheless, several participants in the webinar made the point that the twin problems of coverage and reimbursement are critical issues for digital health as well, a problem that some see as requiring more collaboration between the FDA and the Centers for Medicare & Medicaid Services (CMS).

Medtronic plc has reported the launch of the Inpen integrated with real-time Guardian Connect continuous glucose monitoring (CGM) data. Inpen is the first U.S. FDA-cleared smart insulin pen on the market for people on multiple daily injections (MDI). With this integrated system, users will have real-time glucose readings alongside insulin dose information, giving them what they need to manage their diabetes in one view.

Dialysis maker Outset Medical Inc. tallied $13.8 million in revenue for the third quarter of 2020, up 423% from the prior year period – in its quarter as a publicly traded company. Of that, $10.8 million was product revenue, buoyed by COVID-19 tailwinds that drove demand for Tablo portable dialysis systems.