1. FDA clears Covalon’s MediClear OTC surgical film-drape
Covalon announced in a Sept. 21 press release that the FDA has cleared its MediClear PreOp to market in U.S. hospitals, clinic and directly to patients without a prescription. The MediClear PreOp is a breathable, transparent, self-adhesive, silicone barrier film-drape that can conform to a patient’s skin at a planned incision or insertion site. The film-drape helps protect the patient from bacteria, yeast and viruses. It can be applied by the patient or by clinicians at a consultation prior to surgical procedures. It is then removed immediately before surgery by a clinician in the operating room under sterile conditions.
2. ManaMed launches PlasmaFlow deep vein thrombosis prevention system
ManaMed has launched the first FDA-approved digital and tubeless deep vein thrombosis prevention device, according to a Sept. 21 press release. The deep vein thrombosis prevention device, known as PlasmaFlow, is now available to medical practitioners in the U.S. PlasmaFlow is portable and tubeless with multiple pressure functions. It features a one-button operation, soft cuffs made of a high-grade medical material, 10 hours of rechargeable battery life and two LCD screen with a timer and pressure. It can be used at home or in the hospital to prevent deep vein thrombosis from occurring by stimulating blood flow.
3. Medovex launches DenerveX in Spain
Medovex announced in a Sept. 19 press release that it has launched its DenerveX System in Spain through distributor Prim SA. The DenerveX System denervates and removes capsular tissue from the facet joint during a single procedure. A slowly rotating burr removes targeted facet joint synovial membrane and joint surface as heat ablation destroys tissue and denudes leftover nervous and synovial membrane left on the joint.
4. Getinge and Contego ink European distribution deal
Getinge and Contego have signed a distribution deal stating that Getinge will distribute Contego’s products throughout Europe, according to a Sept. 18 press release. Getinge is set to distribute Contego’s Paladin Carotid Post-Dilation Balloon System and Vanguard IEPTM Peripheral Balloon Angioplasty System, both with integrated embolic protection, in Germany, France, Spain, Portugal, the U.K., Netherlands, Belgium, Austria and Scandinavia.
5. Guerbet gets CE Mark for Victorio chemo mixing system
Guerbet announced in a Sept. 14 press release that its conventional Trans-Arterial Chemo-Embolization (cTACE) mixing and injection system has received CE Mark. The system, known as Vectorio, is a set of Lipiodol resistant medical devices like syringes, stopcock and sampling devices. It is used for mixing and delivery Lipiodol Ultra Fluid and anticancer drugs during cTACE procedures in adults.
6. IBA releases Razor Nano ionization chamber
Ion Beam Applications (IBA) has released its Razor Nano Chamber, according to a Sept. 20 press release. The Nano Chamber is one of the smallest available ionization chambers available on the market. It is a waterproof, ventilated small ionization chamber that has long-term stability and a small diameter of 2 mm.
7. Bioventus launches Exogen study
Bioventus announced in a Sept. 13 press release that it has launched its BONES program and has enrolled its first patients in the study. The BONES program (Bioventus Observational Non-interventional Exogen Studies) is designed to collect data on the use of the Exogen Ultrasound Bone Healing System that uses safe, effective, low-intensity pulsed ultrasound to stimulate the natural bone healing process.
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Dr. Robert Greenberg, Executive Chairman, Alfred E. Mann Foundation
Gary Guthart, President and Chief Executive Officer, Intuitive Surgical
Reggie Groves, CEO, REVA Medical
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