Boston Scientific Corp. reported the U.S. launch of its Directsense technology, a tool to aid electrophysiologists in measuring tissue response to radiofrequency (RF) waves during cardiac ablation procedures. Approved by the FDA in April, the technology is available on the company’s Rhythmia HDx mapping system. Read More
The COVID-19 pandemic has demanded much of the FDA, and commissioner Stephen Hahn said on a June 1 conference call that “there have been hiccups along the way” as the enormity of the threat came into view. The agency’s use of emergency use authorizations (EUAs) has drawn criticism, but Hahn defended those EUAs and other regulatory flexibilities even has he declared that the FDA is not “walking away from” randomized, controlled clinical trials as the gold standard for premarket review. Read More
The Kaiser Family Foundation (KFF) reported that 48% of U.S. adults surveyed had postponed medical care due to the COVID-19 pandemic. In good news, more than two-thirds of those who delayed care expected to get the care they have delayed over the next three months. Read More
Hayward, Calif.-based Reflexion Medical Inc. reported a clinical collaboration with Merck & Co. Inc., of Kenilworth, N.J., to evaluate the safety and efficacy of Keytruda (pembrolizumab) in combination with biology-guided radiotherapy (BgRT) in multiple late-stage cancers. The goal is to establish whether treating multiple tumors with BgRT, a novel external beam radiotherapy treatment (EBRT) modality in development, is safe and amplifies Keytruda’s therapeutic effect. Read More
Investigators are working to develop electrogenetic devices that use remote-controlled electrical stimulation to elicit specific behaviors in engineered cells. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Allergan Aesthetics, Atron Group Avista Capital Partners, Celonova Biosciences, Clarion Medical Technologies, Designplex Biomedical, Evo Design, Ibuttonlink, Ideal Medical, Jet Propulsion Laboratory, Labcorp, Mvent, Minnetronix, Nanovibronix, Pro-Dex, Quanta, Richards Packaging Income Fund, Stark Industries, University of New Mexico, Vacumed, Vacumetrics, Vision Healthcare, Visionquest. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 3nt Medical, Abiomed, Healgen Scientific, Meditech Spine, Rhaeos, Siemens Healthineers, Tissue Regenix. Read More
Keeping you up to date on recent developments in cardiology, including: iPSC microtissue gives clues to heart disease; Two paths for helping patients with heart stents; COVID-19 hits stroke patients. Read More
