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.
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.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Intuitive, Siemens Healthineers.
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.
New hires and promotions in the med-tech industry, including: Brighter, Fujifilm Sonosite, Hyperfine, Iterative Scopes, Madison Core Laboratories, Sphingotec.
After three years of clinical research, Royal Philips NV said its Tack (4-F) endovascular system has shown promising results for arterial dissection repair following balloon angioplasty in patients with critical limb ischemia and infrapopliteal arterial occlusive disease. The data was collected from a 36-month follow-up in the Tack Optimized Balloon Angioplasty (TOBA) II below-the-knee clinical trial.
The U.S. FDA reported a proposed down-classification for two device types intended for detection of melanoma, a move that would ease the premarket path for similar devices. The agency noted that it has received only one PMA application each for optical diagnostic devices and electrical impedance spectrometers, which suggests the agency sees these device types as suffering for want of interest on the part of device makers.
Joining a growing number of diagnostics companies mobilizing to minimize the spread of monkeypox, Novacyt SA and Seegene Inc. reported they have developed new polymerase chain reaction (PCR) assays to quickly diagnose the disease this week. Roche Holding AG released three monkeypox tests for research use in late May. Abbott Laboratories and Becton Dickinson & Co. have similar plans. Stanford Medicine made its own diagnostic available to its patients last week.
RSS
