Abbott Laboratories Inc. has won a nod for MR-conditional labeling on some of its most widely used high voltage devices. The FDA-approved labeling is for the Quadra Assura Mp Cardiac Resynchronization Therapy Defibrillator (CRTD) and Fortify Assura implantable cardioverter defibrillator (ICD).
Sanuwave Inc. finally won de novo approval for its Dermapace diabetic foot ulcer treatment technology after years of struggling to get the device to the U.S. market. The Alpharetta, Ga.-based company's Dermapace uses high-energy acoustic pressure waves in the shock wave spectrum to produce compressive and tensile stresses on cells and tissue structures to elicit a series of biological responses, such as the formation of new blood vessels and the subsequent regeneration of tissue.
About $19.2 billion was generated by both public and private device companies in a total of 394 financings in 2017, according to data compiled by BioWorld MedTech. Public companies brought in about $12.7 billion in 144 transactions while private companies took in about $6.4 billion in 250 financing rounds in 2017.
Cytosorbents Corp.'s march to get its Cytosorb technology available to the U.S. market gained significant momentum last week, after the FDA approved the company's IDE trial. REFRESH 2 is a randomized, controlled, multicenter, clinical trial designed to evaluate intraoperative Cytosorb use as a therapy to reduce acute kidney injury (AKI), as measured by Kidney Disease Improving Global Outcomes criteria, following complex cardiac surgery.
The FDA has granted a de novo request for Procept Biorobotics Inc.'s Aquabeam system for the resection and removal of prostate tissue for the treatment of lower urinary tract symptoms (LUTS) as a result of benign prostatic hyperplasia (BPH), or enlarged prostate. The Redwood Shores, Calif.-based company said it plans to launch the system in 1Q18 on a limited basis.
