• CytoCore (Chicago) said that FDA has approved the company’s 510(k) clearance for its SoftPAP cervical cell collector. The company said that the SoftPAP “collects more comprehensive and complete cervical cell specimens for Pap testing.” “CytoCore’s SoftPAP cervical cell collector is a significant advance in women’s health,” said Robert McCullough, Jr., CytoCore’s CEO. “Each year, over 2 million American women are told that their Pap test was negative when, in fact, they have early stage cervical cancer. These false negatives are frequently caused by an inadequate or incomplete sample of cervical cells. SoftPAP collects complete specimens from the cervical canal, the cervical surface and the transition zone simultaneously” The company cited evidence “that the SoftPAP significantly reduces the rate of false negative Pap tests leading to earlier treatment of cervical cancer.”

• Medical Safety Technologies (McAllen, Texas) introduced its Turtle SafeShot Safety Syringe, calling it the only passive, self-sheathing syringe never exposing the needle during the entire injection process. The syringe is designed to ensure that the needle is never exposed from the time the syringe is taken from its packaging, through the injection process and on to sanitary disposal. The syringe design includes a hard, shatter-resistant and unbreakable sheath on the outside of the needle, which stays intact. A spring-loaded mechanism keeps the sheath constantly against the medication source or patient so that the needle is never exposed to the user. It is available in 3 cc size.

• Mitralign (Tewksbury, Massachusetts) said that it performed its first implantation of the Mitralign percutaneous annuloplasty system for mitral valve repair at French Hospital (Asuncion, Paraguay). The Mitralign was able to remodel the valve and reduce the patient’s mitral regurgitation (MR) from 3+ to 2+, 24 hours after the procedure, based on lab assessment. The patient spent less than 48 hours in the hospital after the procedure and continues to do well at home, Mitralign said, the system emulating the open surgical procedure of suture-based mitral annuloplasty. The implant was delivered percutaneously though a single 14 Fr femoral arterial sheath, providing direct geometric reduction of the posterior annulus. Mitralign is developing a catheter-based methods to treat MR in patients suffering from congestive heart failure.

• Reliant Technologies (Mountain View, California) launched its Fraxel re:pair laser system for dermatology. The Fraxel re:pair laser is a minimally invasive, ablative fractional laser system that delivers aesthetic treatment from fractional microderm ablation treatment to fractional deep dermal ablation. It can be operated by a single clinician because of its built-in smoke evacuation system and is capable of treating at depths from 300 m to 1.6 mm into the dermis.

• The Oncology Care Systems unit (Concord, California) of Siemens Medical Solutions received FDA clearance for the sale of its Artiste solution, a linear accelerator engineered specifically for adaptive radiation therapy (ART). This radiation therapy solution offers clinicians multiple imaging modalities. From Megavoltage (MV) to gold-standard, in-room CT imaging, clinicians can select the optimal imaging application for their treatment approach. Siemens’ MVision cone beam imaging package delivers outstanding soft-tissue resolution, especially in challenging cases, such as imaging prostheses and with large patients. The CTVision CT-on-rails system provides in-room, diagnostic quality imaging, thus opening up opportunities to implement benchmark concepts, such as daily re-planning.