The U.S. CMS had the usual mix of good news and bad news in its hospital outpatient final rule for calendar year 2023, which served up a plate of bad news for Brainscope Inc. and Elucent Medical Inc., which will enjoy no new technology pass-through (NTPT) payments in the coming year for their applications. Conversely, Carlsmed Inc. and Microtransponder Inc. both came out of the annual NTPT scrum with wins, thus ensuring they’ll be able to more rapidly recapture their med tech investments. Read More
Femasys Inc. revised the design for its Femaseed pivotal trial to focus on couples experiencing male factor infertility, which accounts for about half of all cases of infertility today. Femaseed delivers sperm directly to the fallopian tube where an egg is released. As a result of the redesign, the Femaseed trial will need just one-quarter the number of treatment cycles originally anticipated. Read More
Oncores Medical Pty Ltd. reported positive data from its first in-cavity trial of its quantitative micro-elastography (QME) imaging system, a hand-held imaging tool that helps surgeons differentiate between cancerous and healthy breast tissue at the point of surgery. Read More
Diagnostic Medical Systems Group SA (DMD) is selling its entire stake in the share capital of Hybrigenics SAS, a biotech company listed on the Paris Euronext Stock Exchange since 2007. This sale of 116,911,328 shares, representing 43.41% of Gard, France-based Hybrigenics’ share capital, will allow DMS Group to refocus on its core imaging business. “We will strengthen our free cash in order to ramp the launch of new technology in medical imaging,” Samuel Sancerni, CEO of Diagnostic Medical Systems, told BioWorld. Read More
While weekly global and U.S. confirmed cases of COVID-19 are below each of the last two years, infectious disease experts remain on guard. There are still about 1,500 people dying around the world each day, including 350 in the U.S., and the SARS-CoV-2 virus may continue to find ways to outmaneuver current treatments and vaccines. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Acutus, Ascensia, Illumina, Medtronic, Microport, Pixee, Senseonics, Sernova, Twist Bioscience, Viz.ai, Us2.ai. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Accelus, Fresenius Medical Care, Grifols, Orasure Technologies, Prosomnus. Read More
