NuVasive has gained premarket approval (PMA) for its cervical motion preserving system from the US Food and Drug Administration (FDA). The PCM cervical disc device, which is comprised of superior and inferior endplates, is designed for ...
Tags: cervical motion preserving system, PCM cervical disc device, FDA
Roche's Accu-Chek Combo system has been cleared by the US Food and Drug Administration (FDA) for insulin pump therapy. The Accu-Chek Combo system features an insulin cartridge that can hold up to 315 units of insulin, as well as a ...
The US Food and Drug Administration (FDA) has approved Abbott's Healon EndoCoat ophthalmic viscosurgical device (OVD). The Healon EndoCoat OVD is a clear, viscous, protective gel intended for use as a surgical aid in cataract ...
Tags: FDA, clinical product, ophthalmic viscosurgical device
The US Food and Drug Administration (FDA) has approved pSivida's investigational new drug (IND) application for injectable sustained-release micro-insert, designed as a treatment for posterior uveitis. pSivida's injectable ...
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Vitacon's VitaScan LT USB bladder scanner, designed for measuring bladder volume in real-time which avoids the placement of indwelling urethral catheters, a major ...
Tags: bladder scanner, FDA, clinical device
The US Food and Drug Administration (FDA) has granted 510(k) clearance to NovaBay Pharmaceuticals' NeutroPhase skin and wound cleanser for use in moistening and debriding graft and donor sites. The approval allows the company to use ...
Tags: FDA, wound cleanser, clinical application
Globus Medical has obtained premarket approval (PMA) from the US Food and Drug (FDA) for its articulating intervertebral disc replacement device, designed for patients with intractable symptomatic cervical disc disease (SCDD) between ...
Tags: FDA, articulating intervertebral disc replacement device
The US Food and Drug Administration (FDA) has granted 510(k) approval to Kinetic Concepts for new indication use of vacuum assisted closure (VAC) therapy system. The new indication for VAC therapy for closed incision management will ...
The US Food and Drug Administration (FDA) has approved Immunetics' BacTx rapid test to detect bacterial contamination in platelet units. The clearance allows BacTx test to use on leukocyte-reduced whole blood-derived platelet units, a ...
Microsulis Medical has obtained the US Food and Drug Administration's (FDA) approval for upgraded version of its Accu2i pMTA applicator, designed for use as part of the company's Acculis Microwave Tissue Ablation (MTA) system. The Accu2i ...
Tags: Medical, microwave tissue ablation applicator, applicator
Teleflex's Arrow FlexTip Plus Closed Tip, multi-port epidural catheter has been granted 510(k) clearance by the US Food and Drug Administration (FDA). The Arrow FlexTip Plus Closed Tip catheter utilizes the same technology of the ...
The US Food and Drug Administration (FDA) has cleared Boston Scientific's subcutaneous implantable cardioverter defibrillator (S-ICD) to treat patients at risk for sudden cardiac arrest (SCA). The CE-marked system, which the company ...
Tags: FDA, CE-marked system, S-ICD system
The US Food and Drug Administration (FDA) has cleared Covalon's SurgiClear antimicrobial silicone adhesive film dressing. SurgiClear antimicrobial silicone dressing is designed to cover and protect wound sites and wound closure ...
Tags: FDA, dhesive film dressing, clinical product, clinical application
The US Food and Drug Administration (FDA) has granted 510(k) approval to Avery Dennison Medical Solutions' new non-cytotoxic, grade 0 profile transparent wound film dressing, designed to treat catheter-related blood stream infections. ...
Tags: FDA, wound film dressing, clinical product, clinical application
The US Food and Drug Administration (FDA) has granted 510(k) approval to Surefire Medical's High-Flow Microcatheter. The Surefire Microcatheter, comprising of expandable tip, is designed to deliver therapy with higher infusion ...