European regulators have given BonAlive Biomaterials the CE mark for its bone graft substitute designed to address bony gaps and voids. BonAlive Putty, which can promote bone growth within six to 12 weeks of implantation, comes in a small applicator for cranio-maxillofacial and hand surgery and a bigger applicator for use in trauma and orthopedic procedures.
Combining mastopexy and breast enhancement in a single operation is as safe as performing the procedures separately, a retrospective review found. The combined procedure is less expensive but is more technically complex, according to researchers. The single-center study was published in the journal Plastic and Reconstructive Surgery.
The FDA has cleared Medical Modeling to market its virtual surgical planning systems for use in maxillofacial and oral surgery. The portfolio includes VSP Orthognathics, which allows CAD/CAM surgical splints and virtual surgical planning to be applied to the orthognathic procedure site, and VSP Reconstruction, which involves the use of vascularized grafts to repair the mandible or maxilla.
AirXpanders has obtained CE mark approval in Europe to market AeroForm, a tissue expander intended for use in women receiving breast reconstruction after mastectomy. The technology, which currently is undergoing an investigational device exemption clinical trial in the U.S., allows patients to inflate the implant remotely and at a desired rate.
Myoscience's Focused Cold Therapy device has received FDA approval for targeted pain relief. European and Canadian regulators have approved the device as an anti-wrinkle treatment whose effect is temporary.