Routine use of Impella CP in patients who had a heart attack with cardiogenic shock cut mortality by 12.7% at six months compared to standard care, researchers reported in a late breaking presentation at the American College of Cardiology Scientific Sessions in Atlanta. Read More
Medtronic plc reported data from a head-to-head trial backing its Evolut TAVR system against competitor Edwards Lifesciences Corp.’s Sapien platform, and the data showed particular promise of the Evolut in patients with a small aortic annulus, which would appear to be most beneficial for women in particular. Read More
“Hot and cold tumors may need different types of immunotherapy,” Jay Berzofsky told the audience as the American Association for Cancer Research’s (AACR) 2024 annual meeting kicked off this weekend. In an educational session on cancer vaccines, Berzofsky, who is head of the National Cancer Institute’s Molecular Immunogenetics and Vaccine Research section, explained that when immunotherapy fails in hot tumors, it fails despite the existence of an immune response, due to an immunosuppressive microenvironment. Read More
The U.S. FDA proposed in November 2023 to up-classify many wound care products that are associated with antimicrobial resistance, a change that would require a large number of clinical trials and a large volume of new premarket applications for the agency. Read More
Top of FormMed-tech financings in March totaled $1.79 billion. Although a decline from February’s total, the cumulative value for the first three months of the year reached $6.02 billion, an increase from $4.69 billion during the same period the previous year. Read More
While the notion of a medical device single review program is still more aspirational than respirational, a number of nations are shifting incrementally toward mutual recognition for medical devices. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Clew Medical, Heartbeam, Icad, J&J, Myriad Genetics, Shockwave Medical. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Agenus, Atmo, Bayer, BBI, Carthera, Early Is Good, Empire Genomics, Eyenovia, Ibex, Icad, Densitas, Immunovia. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: IR-Med, Orthobond, TAE Life Sciences. Read More