From the FDA’s clearance of Covalon’s film-drape to Bioventus launching its study, here are seven medtech stories we missed this week but thought were still worth mentioning.
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.