Complete Genomics Inc. launched a new line of genetic sequencers designed to decode DNA in greater quantities – and at a lower price point – than existing sequencing tools. The new products could signal a new era of more affordable testing, leading to wider availability and the potential to fulfill the long-desired promise of precision medicine. Read More
Truleaf Medical Ltd., a subsidiary of Israel-based Allmed Solutions, is ready to begin human trials of its Rosedoc platform to replace the heart’s leaky mitral valve using cardiac catheterization. Read More
The U.S. FDA raised some hackles with its final guidance for clinical decision support (CDS) software, thanks to provisions that some stakeholders argued flew against congressional intent regarding the regulatory status of some device functions. That final guidance is now the target of a petition by the CDS Coalition to withdraw and rewrite the final guidance, arguing that the agency is “doing an end run” around the limitations established by Congress regarding the FDA’s oversight of software as a medical device (SaMD). Read More
Woebot Labs Inc. posted uplifting news for women who have suffered from baby blues and their big brother, post-partum depression. The company recently enrolled the first patient in its pivotal trial of WB001, a digital therapeutic for post-partum depression (PPD). WB001 received U.S. FDA breakthrough device designation in 2021, indicating the acute need for accessible treatment for the common condition. Read More
Following on from wireless weighing scales, blood pressure monitors and smartwatches designed to track health indicators, Withings SA is now developing home urine analysis products. Read More
Med-tech firms raising money in public or private financings, including: Deep Breathe, Garuda, Mediwound, Renalytix, Rxsight, Treace Medical Concepts, Vapotherm. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Dariohealth, Dexcom, Guardant, Isoray, Paragonix, Perspective Therapeutics, RBC Medical Innovations, Sequana, Sterling Medical, Titan Medical, Viewpoint Molecular. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: BD. Read More
