BTG announced U.S. Food and Drug Administration 510(k) clearance has been granted to the EKOS® Control Unit 4.0. The EKOS® system includes an ultrasonic device that uses acoustic pulses, powered by the new Control Unit 4.0, to quickly and safely dissolve blood clots and restore blood flow in patients with pulmonary embolism (PE), deep vein thrombosis (DVT), and peripheral arterial …

AV Medical Technologies, Ltd. announced today that its Chameleon™ PTA balloon catheter has received FDA clearance for an expanded indication to include infusion of diagnostic or therapeutic fluids. “The Chameleon™ balloon offers advantages for experienced operators as well as those training in dialysis access procedures,” commented Dr. John Ross of the Dialysis Access Institute in Orangeburg, SC. “We appreciate the …

E-QURE Corp. announced it has received marketing approval for the Company’s patented Bio-electrical Signal Therapy Device (“BST Device”) in Israel from the Israeli Ministry of Health. The Accessories and Medical Devices Registration (AMAR) is granted in order to secure safety and efficacy for medical devices used in Israel. BST is a breakthrough novel electrotherapy for the non-invasive treatment of hard-to-heal …

Since its inception, Paragon 28 has obsessed over every aspect of foot and ankle surgery. Committed to creating tailored solutions to improve surgical outcomes, Paragon 28 has launched innovative products and instrumentation that help to streamline procedures, allow surgeons flexibility in technique and approach and facilitate reproducible results benefitting both the surgeon and patient. Today, Paragon 28 adds to its …

Accelerate Diagnostics, Inc. announced that the U.S. Food and Drug Administration has granted the de novo request to market the Accelerate Pheno™ system and Accelerate PhenoTest™ BC kit for identification and antibiotic susceptibility testing of pathogens directly from positive blood culture samples. The blood culture kit is indicated for susceptibility testing of specific pathogenic bacteria commonly associated with bacteremia, the …

Laboratory Corporation of America® Holdings, Providence Health & Services (Providence) and Catholic Health Initiatives (CHI) announced that they have entered into a definitive agreement for LabCorp to acquire all of the ownership interest in Pathology Associates Medical Laboratories, LLC, (PAML), one of the nation’s premier medical reference laboratories and a healthcare solutions company jointly owned by Providence and CHI. In …

Vention Medical (Vention), a KRG Capital Partners Fund IV (KRG) portfolio company and integrated services provider for the design, engineering and manufacturing of complex medical devices and components, has entered into merger agreements with separate buyers to sell the business in a two-step transaction. The Advanced Technologies segment will be acquired by Nordson Corporation, the leader in precision dispensing, fluid …

Wenzel Spine, Inc. announced that it has completed the acquisition of the PrimaLOK™ SP Interspinous Fusion System and PrimaLOK™ FF Facet Fixation System from OsteoMed, LLC. The PrimaLOK SP & FF platforms include a polyaxial interspinous process device and percutaneous facet screw system designed for MIS applications in treatment of lumbar spinal disorders. These patented technologies are designed to provide …

Henry Schein Medical announced that it has signed an exclusive distribution agreement with Rijuven, which develops innovative digital medical devices, to sell its CardioSleeve diagnostic device to medical practitioners. CardioSleeve is a stethoscope attachment that records synchronized electrocardiogram (ECG) and heart sound signals, transmits real-time data to any smartphone or tablet via Bluetooth, and offers cloud-based analysis to help physicians …

At the Health IT Conference (HIMSS) 2017 in Orlando, Siemens Healthineers has announced a digital platform for healthcare providers as well as for providers of solutions and services, aimed at covering the entire spectrum of healthcare. The platform is to foster the growth of a digital ecosystem linking healthcare providers and solution providers with one another as well as bringing …