With strong one-year results from the PULSAR trial, Kardium Inc. could soon be jockeying for third place in the race for pulsed field ablation market share. Boston Scientific Corp. clearly won the roses, with Medtronic plc solidly positioned to place, but the show spot – previously called as a battle between Johnson & Johnson and Abbott Laboratories – could go to this Canadian dark horse. Read More
Viromed Medical AG recently signed a couple of deals to get its devices based on cold plasma technology into the hands of clinicians to treat patients with skin diseases and pneumological infections. Read More
The U.S. Department of Justice may have dismantled its civil division, but that doesn’t mean companies in the life sciences can let their guard down. Read More
Physicians aren’t the only ones who see prior authorization (PA) practices as a significant problem, but John Brooks, deputy administrator at CMS, told a med tech audience that a renewed focus on Medicare Advantage plans’ use of PA will not yield tangible results overnight. Read More
Following a complete response letter last year, Satsuma Pharmaceuticals Inc. received U.S. FDA approval of dihydroergotamine nasal powder to treat acute migraine with or without aura. Branded Atzumi, it is the first product that uses Satsuma’s SMART (Simple MucoAdhesive Release Technology) platform that combines an advanced powder and device technology aimed at making delivery more simple. Read More
The first 100 days of the Trump administration have been nothing short of chaotic, both in the U.S. and throughout the world. Shining a light through the uncertainty, BioWorld continues to cover the administration’s latest policy decisions and actions affecting the life sciences sector, as well as their impacts across the globe. It’s all right here at Trump administration impacts. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Akoya, Bestbrick, Electrocore, Elutia, Houston Research, Lumendi, Neurosigma, Nexalin, Pinnacle Clinical, Quanterix, Resmed, S&E Bio, Summit Clinical, Surgibox, Virtuox. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Faceheart. Read More