New medical instruments with integrated soft electronics could improve diagnosis and treatment of cardiac conditions. The surgical tools use soft materials that conform to the body’s tissue and permit a single catheter to combine diagnostic and therapeutic functions while providing real-time feedback and electrophysiological information.

Israeli startup Envizion Medical Ltd. said it is partnering with one of the largest private U.S. hospital chains to deploy its electromagnetic fields-guided feeding tube placement navigation technology in 150 hospitals nationwide. The company received U.S. FDA 510(k) clearance for the Envue navigation device and Envizion feeding tubes in April 2019.

The U.S. Centers for Medicare and Medicaid Services (CMS) has moved incrementally to date on the Medicare inpatient-only (IPO) list for a number of procedures, but the agency recently proposed to eliminate the IPO list altogether by 2024. The Advanced Medical Technology Association (Advamed) cautioned that the elimination of the entire IPO list should at the least be accompanied by a monitoring of outcomes to ensure that quality of the services is not affected, but also said the translation of payment codes for outpatient performance of these procedures might lead to inadequate reimbursement rates.

The U.S. Centers for Medicare and Medicaid Services (CMS) finalized its Medicare inpatient payment rule for fiscal 2021, and Boston Scientific Corp., of Marlborough, Mass., was perhaps a surprise winner with a new technology add-on payment (NTAP) for its Eluvia paclitaxel-coated stent for the lower limbs. The Eluvia had faltered at a previous NTAP application due to the controversy over paclitaxel in devices for the peripheral vasculature, but Boston Scientific said in a Sept. 3 press release that the decision to grant an NTAP payment “is particularly important,” given the scrutiny applied to paclitaxel’s use in these devices.

While the emergency use authorization (EUA) the FDA granted Aug. 23 for convalescent plasma remains a political talking point, the agency moved ahead Sept. 2, issuing an updated, immediately effective guidance on the use of convalescent plasma to treat COVID-19 patients in ongoing clinical trials, on an expanded access basis or under the EUA.

The need for self-administered surveillance testing finally has a few candidates, thanks to labs and test developers across the globe, and the U.S. FDA is keen on exploiting the opening. Tim Stenzel, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health, said on the agency’s Sept. 2 testing town hall that the agency is interested in a test intended to be self-administered multiple times compared to a test validated under a single test approach, a flexibility that may prove critical in advancing the U.S. approach to testing for the COVID-19 pandemic.

The idea of being able to produce vaccines at the point of care with the push of a button may sound futuristic, but Codex DNA Inc. claims it will have the first fully automated, tabletop vaccine printer ready for the market in 18-24 months. Will this be a game-changer in rolling out a COVID-19 vaccine? Probably not. But the technology could better position health officials to respond to the next pandemic, or eventually to produce a better, faster influenza vaccine each year.

The U.S. Centers for Medicare and Medicaid Services (CMS) capped off the month of August 2020 with one of the more significant Medicare coverage documents in recent memory. The more immediately impactful part of the proposed rule would offer immediate coverage for devices approved or cleared under the FDA’s breakthrough devices program, but the broader element of this proposed rule offers a definition for the term “reasonable and necessary,” a development that itself constitutes a breakthrough in the world of Medicare coverage of medical technology.

The Court of Justice for the European Union (CJEU) has invalidated the EU-U.S. Privacy Shield, a mechanism designed to ensure the privacy of EU citizens’ data when conveyed to other nations in a manner consistent with the EU’s General Data Protection Regulation (GDPR). Makers of drugs and devices are not without recourse in transferring patient data to the U.S. for clinical trials conducted in Europe, but industry must revisit their standard contractual clauses to ensure those protocols provide the necessary privacy provisions, or face fines that could amount to tens of millions of euros.