• American Bio Medica (ABMC; Kinderhook, New York) said that it has commenced manufacturing diagnostic test strips for Syphilis for Hema Diagnostic Systems (HDS; Miami Beach, Florida), a privately held manufacturer of rapid diagnostic tests for infectious diseases. HDS will incorporate the ABMC Syphilis test strip into HDS’ Rapid 1-2-3 Hema Express delivery system. The Express is a patent pending device that provides a simple, efficient and cost effective method that allows testing at the point of care. The Express uses a simple, pre-marked series of lines on the sample pad, which is used to clearly identify when sufficient blood has been taken up onto the pad. This feature aids in eliminating guesswork and ensures reliable, repeatable test results. American Bio Medica makes accurate, cost-effective immunoassay diagnostic test kits, including point of collection tests for drugs of abuse.

• Biolase Technology (Irvine, California) reported receiving FDA clearance to market a version of its Waterlase MD Laser system for use in dermatological applications as well as general and plastic surgery. New indications for the device include incision, excision, ablation, vaporization and coagulation of dermatologic tissues including epidermal nevi, cheilitis, keloids, verrucae, skin tags, keratosis, scar revision, debulking of tumors, cysts, diagnostic biopsy and skin resurfacing. In addition, general surgical use of the device is now allowed for incision, excision, vaporization and coagulation of soft tissue where skin incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue ablation and/or vessel coagulation may be indicated. Biolase is a dental laser company.

• Rubbermaid Medical Solutions (RMS; Huntersville, North Carolina) reported the launch of the Mini Med Module with mounting bracket for the motion computing C5 mobile clinical assistant (MCA). Key features for the mini med module include: compact 14” wide base enables cart to easily get to point of care, electronic PIN code locking medication drawers with a timed auto-locking feature, and a large bottom drawer for storing supplies or the C5 MCA when it is not in use. Rubbermaid Medical Solutions makes medication carts and mobile computing solutions.

• Life Spine (Hoffman Estates, Illinois) FDA clearance to market the Kinetic-SL, an internally dynamized anterior cervical plating system. The plate, with an exceptionally thin profile as well as a narrow plate width (16mm), was created from the clinical need to address small stature patients. Kinetic-SL features 0-2mm of fully adjustable internal dynamization per level and an ultra slim pre-lordosed profile. Plate sizes range from 21mm to 111mm, in levels one to five. Life Spine improves the quality of life for spinal patients by increasing procedural efficiency and efficacy through design and manufacturing platforms.

• The Female Health Company (Chicago) said that the PMA it submitted for its second generation product, FC2 female condom, has been accepted by the FDA for review. The Center for Devices and Radiological Health (CDRH) received FHC’s PMA on Jan. 8. The FC female condom is primarily distributed by public health organizations and donor groups in over 90 developing countries around the world. World-wide, the female condom is available in various programs in 108 countries, the company said. It says that the female condom is the only FDA-approved product controlled by a woman that offers dual protection against sexually transmitted diseases, including HIV/AIDS, and unintended pregnancy.

• Wright Medical Group (Arlington, Tennessee) reported a limited launch of its Biofoam Cancellous Titanium Tibial Base, the latest addition to its Advance knee systems. The Biofoam features a bone-like titanium with a roughened texture that “bites” into bone for cementless fixation of the impant, according to the company. Wright makes reconstructive joint devices and biologics.

Wright also reported new product and technique innovations for its comprehensive line of solutions for hip surgery. The introductions include the company’s first cemented modular neck hip implant, a new revision stem that combines wedged-stem design with modular neck technology, and a total hip arthroplasty surgical technique that does not require the hip to be dislocated during the procedure. The Supercar technique for total hip arthroplasty was developed by Stephen Murphy, MD, of New England Baptist Hospital (Boston). The goal of this approach is to safely perform total hip arthroplasty while minimizing the effects on the surrounding soft tissues. A feature of the approach is that it does not require surgical dislocation of the hip during the procedure, resulting in maximum preservation of the surrounding soft tissue. The technique is performed through a single incision, which may help reduce patient recovery times for a quicker return to everyday life. Wright Medical Group is an orthopaedic medical device company.