US-based Precision Spine has announced it will introduce several new and expanded product offerings at 28th annual North American Spine Society Meeting being held October 9-12 of this year in New Orleans, Louisiana. The company will ...
Tags: Precision Spine, Spinal Implants
Nucletron, an Elekta Company, has obtained 510(k) approval from the US Food and Drug Administration (FDA) for Esteya electronic brachytherapy system, a new approach for high precision skin cancer treatment. Depending on a small, high dose ...
Precision Spine, a spinal device company, has obtained 510(k) approval from the US Food and Drug Administration (FDA) for additional components of its Reform pedicle screw system, designed to treat spinal deformities. The additional ...
Beckman Coulter, a manufacturer of biomedical laboratory instruments, has obtained the 510(k) approval from the US Food and Drug Administration (FDA) for its Access AccuTnI+3 troponin I assay for use on the UniCel DxI series of immunoassay ...
Tags: Beckman Coulter, Cardiac Disease
US-based Crosstrees Medical has obtained 510(k) approval from the US Food and Drug Administration (FDA) for the Crosstrees PVA pod system for percutaneous vertebral augmentation (PVA). The FDA approval for the CE marked Crosstrees PVA pod ...
Therapeutic devices developer Abyrx has received 510(k) approval from the US Food and Drug Administration (FDA) for its new resorbable hemostatic bone putty called Hemasorb Plus that achieves hemostasis by mechanical tamponade. Hemasorb ...
Clinical lab instruments developer Magellan Diagnostics has received the US Food and Drug Administration (FDA) 510(k) approval to market its LeadCare Ultra blood lead testing system in the US. Claimed to be the first plug-and-play ...
SynGen has received 510(k) approval from the US Food and Drug Administration (FDA) to market its SynGenX-1000 System, CryoPRO-2 Cryopreservation/Storage Bag Set, SynGen DataTrak software products to process cord blood. Previously, the ...
Tags: Cord Blood Processing, Syngen
Boston Scientific's Guidezilla Guide Extension Catheter has secured 510(k) approval from the US Food and Drug Administration (FDA) and CE Mark, which would enable the company to market the device in the US and European markets. The ...
DJO Global has launched its Empi Phoenix, an electrical stimulator that simplifies the treatment of muscle atrophy pre and post surgery for total knee replacement or ACL repair. The Empi Phoenix is a prescription medical device that ...
Tags: Knee Treatment, Medicine
NeuroMetrix, a US-based medical device company, has received 510(k) approval from the US Food and Drug Administration (FDA) for its transcutaneous electrical nerve stimulator, called Sensus Pain Management System. Sensus Pain Management ...
Tags: medical device, Pain Management
Royal Philips has secured 510(k) approval from the US Food and Drug Administration (FDA) to market its AlluraClarity live image guidance system. The company's AlluraClarity system, equipped with ClarityIQ technology, offers quality ...
Tags: Philips, FDA Approval, X-ray System
Merit Medical, US-based cardiology, radiology and endoscopy disposable devices manufacturer and distributor, has received multiple regulatory approvals from various regulatory bodies. Merit's advanced high-pressure inflation device, ...
Tags: Merit Medical, Medical Devices
US-based medical aesthetics provider Solta Medical has received 510(k) approval from the US Food and Drug Administration (FDA) for its Fraxel DUAL 1550/1927 laser system, which can be used to treat pigmented lesions including solar lentigos ...
Beckman Coulter, a subsidiary of Danaher Corporation, has received 510(k) approval from the US Food and Drug Administration (FDA) for its new Access AccuTnI+3 troponin I assay for use in its Access 2 immunoassay system. In October 2010, ...
Tags: Beckman Coulter, Medicine