Irvine, Calif.-based Axonics Modulation Technologies Inc., which is marketing implantable sacral neuromodulation (SNM) devices for the treatment of urinary and bowel dysfunction, reported the submission of a premarket approval (PMA) supplement. Specifically, it is looking to gain full-body magnetic resonance imaging-conditional labeling for 3.0 Tesla (T) MRI scans. Read More
Many adaptations to the coronavirus pandemic will remain standard features of health care long after the pandemic wanes, according to Brian Chapman, managing partner at ZS Associates, an Evanston, Ill.-based pharmaceutical and medical technology consultancy. In the long term, telehealth will be a clear winner as payers look to lower ongoing costs, more procedures and care will move out of hospitals, rapid diagnostics will gain importance, and government and payer coverage of infectious disease testing of all kinds will expand, he predicted. Read More
The emergence of the new variety of coronavirus has had a massive effect on medical care across the globe, which has boosted telehealth coverage while suppressing non-emergency procedures. Several medical societies have published guidelines for procedures during the COVID-19 outbreak, however, which in the aggregate suggest that many procedures will be significantly delayed. Read More
Palo Alto, Calif.-based Varian Medical Systems Inc. is no stranger to machine learning applications. It rolled out its first such software to guide photon-based radiotherapy treatment planning more than five years ago. Now, it’s expanding a similar approach for machine learning-driven patient matching and treatment guidance in proton treatment planning. Read More
Olympus Medical Systems Group, of Center Valley, Pa., a division of Olympus Corp., is preparing the U.S. launch of the Itind device for the treatment of benign prostatic hyperplasia (BPH), following FDA de novo authorization earlier this year. The nonsurgical, minimally invasive treatment is made by Medi-Tate Ltd., of Or-Akiva, Israel. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Medi-Tate, Merit Medical, Olympus. Read More
Keeping you up to date on recent developments in cardiology, including: Patient data registry aims to give insights for care, adverse cardiovascular outcomes; Research: Medicare changes could boost TAVR access; Muscle protein serves essential role in blood clotting during heart attack. Read More
