Abbott Laboratories recently received FDA clearance for Tendyne, its transcatheter mitral valve replacement system. The news comes on the heels of Edwards Lifesciences Corp. securing a CE mark for its Sapien M3 system and is a boon for mitral valve therapies amid ongoing frustrations about the slow adoption of TMVR technologies. Read More
The U.S. Department of Justice is reshuffling its enforcement focus for the coming three years per a May 12 memo attributed to Matthew Galeotti, director of the department’s criminal division. Galeotti said federal attorneys should avoid prosecutorial adventurism in an effort to strike what he described as “an appropriate balance” between enforcement and “unnecessary burdens on American enterprise.” Read More
Asian health care-focused private equity firm Quadria Capital announced the final close of its Fund III with $1.07 billion in total commitments to transform health care across Asia, which is expected to drive 40% of global health care growth by 2030. Read More
The EU is having another go at improving access to capital for biotechs and science-based startups, in a bid to enable them to remain anchored in Europe. The Startup and Scaleup strategy, announced on May 28, is a response to the long-running problem that although Europe has strong foundations in its academic research, the innovative companies this science spawns often end up being acquired by U.S. companies, or moving to the U.S. to list on Nasdaq or the New York Stock Exchange. Read More
A dynamic chart of the latest executive orders (EOs) from the Trump administration that have been published in the Federal Register and that directly impact the biopharmaceutical and medical technology sectors. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Astrazeneca, Danaher, Essilorluxottica. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Iradimed, Reflow Medical. Read More
