Transcatheter aortic valve replacement (TAVR) devices continue to make a splash in the world of medical technology, with the Sapien 3 by Edwards Lifesciences Corp. leading the way. Results of the EARLY TAVR study strongly suggest a need for implant in asymptomatic patients with severe aortic stenosis, a development that should help sustain and possibly increase sales of these devices for the next few years. Read More
FDA commissioner Bob Califf made it his mission to counter medical and food product misinformation, and described the dilemma as an emergency at an Oct. 28 public meeting. Read More
The U.S. FDA cleared Paragonix Technologies Inc.’s Kidneyvault portable renal perfusion system, which combines digital monitoring capabilities and hypothermic perfusion technology to preserve donor kidneys during transportation. Read More
Some rare skin diseases not only reduce the quality of life of patients, but also can be devastating conditions, leading to amputations or death. At the 31st annual congress of the European Society of Gene and Cell Therapy (ESGCT), held last week in Rome, different laboratories showcased their approaches to editing mutations related to this group of diseases. Read More
The third PCT family of patenting to emerge from IR Medtek LLC, and its first as the sole named assignee, sees its CEO, Douglas Cohen, continue to build protection for the company’s platform which uses a light detection technology and machine learning to improve the accuracy of cancer diagnosis. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Advanced Nanotherapies, Conavi, Corvia, Edwards, Roivios, Vahaticor. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbott, Adona, Adx, Alamar Biosciences, Biocardia, Cleerly, Delfi Diagnostics, Fujirebio, Histosonics, Incendia Therapeutics, Posit Science, Shifamed, Tidepool. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Distalmotion, Paragonix Technologies, Vantis Vascular. Read More