A new cancer genomic test co-developed by Illumina Inc. and Merck & Co. Inc. will soon be available globally, excluding the U.S. and Japan. The research use only Trusight Oncology 500 HRD test is designed to identify genetic mutations used in the evaluation of homologous recombination deficiency (HRD), a signal that can indicate tumor formation. The product combines HRD technology from genetic test maker Myriad Genetics Inc. and next generation sequencing (NGS) technology from Illumina. Read More
If timing is everything, Femasys Inc.’s Fembloc has everything on its side. While the company’s dual tracks addressing infertility and providing permanent contraception may appear at odds, they both serve to put greater control of reproductive decisions and treatment in the hands of women. A permanent contraceptive, Fembloc offers an alternative to surgical tubal ligation by encouraging scar tissue growth in the fallopian tubes in an office-based procedure. Read More
Device servicing by third parties has been topical of late, although not in the context of continuous positive airway pressure (CPAP) systems. That seems likely to change thanks to the ongoing recall of CPAP machines made by Philips Respironics Inc., of Murrysville, Pa., which was driven by reports of degradation of foam used in the device for insulation. Read More
If GE Healthcare’s GM of Monitoring Solutions Neal Sandy gets his way, nursing staff will perk up and notice a newly launched wireless patient monitoring system that helps them detect patient deterioration much earlier than periodic, manual monitoring. Read More
As was the case for all medical device inspections, the Medical Device Single Audit Program (MDSAP) was hampered by the COVID-19 pandemic, but the participant regulators agreed to allow the use of remote audits to fill in for live MDSAP inspections. This program has been renewed again through the end of September 2022, but the sponsoring regulatory agencies said this will be the last extension, barring exceptional circumstances. Read More
New hires and promotions in the med-tech industry, including: Brighter, Fujifilm Sonosite, Hyperfine, Iterative Scopes, Madison Core Laboratories, Sphingotec. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 3Spine, Immunovia, Biodesix, Etiometry, Royal Philips, Radiometer Medical, Uro Medical. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Intuitive, Siemens Healthineers. Read More
