The FDA in July approved the first molecular-based laboratory test designed to detect whether breast cancer has spread (metastasized) to nearby lymph nodes. The GeneSearch Breast Lymph Node (BLN) Assay from Veridex (Warren, New Jersey), a Johnson & Johnson (New Brunswick, New Jersey) company, detects molecules that are abundant in breast tissue but scarce in a normal lymph node, the agency said.

The assay is designed to detect the spread of cancer into the lymph nodes more accurately than existing rapid methodologies and, as a result, has the potential to reduce the need for stressful and costly second surgeries for breast cancer patients, according to Veridex.

"It’s always great to be the first to market with a test like this... we’re very excited," Steve Dnistrian, a company spokesman, told Biomedical Business & Technology. "It’s all about improving the standard of care for breast cancer patients."

He noted that the GeneSearch BLN Assay is the first in vitro diagnostic test approved in the U.S. for the rapid detection of metastases greater than 0.2 mm in sentinel lymph node tissue removed from breast cancer patients, Veridex said. The presence or absence of breast cancer cells in underarm lymph nodes is a powerful predictor of whether the cancer has spread and is used to help decide appropriate therapy for a woman with metastatic breast cancer, according to the FDA.

The first lymph node that filters fluid from the breast is called the sentinel node, because that is where breast cancer cells are likely to spread first, the agency said. During a lumpectomy or mastectomy to remove a breast tumor, surgeons commonly remove the sentinel node for examination. Sometimes the sentinel node is examined immediately and if tumor cells are found, additional lymph nodes are removed. A more extensive microscopic examination, requiring one to two days for results, is almost always performed. If tumor cells are only found with the later microscopic examination, the patient may require a second surgery to remove the remaining lymph nodes.

"The question for the patient and the physician during that initial operation is ‘has the cancer spread?’ And this test is designed to answer that question and offer assurance, accuracy and confidence... ." Dnistrian said. "[Physicians] want to know for certain, at that moment, ‘is it in the lymph nodes or not? It is a break through."

In a clinical trial, the GeneSearch BLN Assay showed strong agreement with results from extensive microscopic examination of the lymph nodes of 416 patients, the FDA said. According to the agency, the test accurately predicted that breast cancer had spread nearly 88% of the time in women with metastasis and patients without metastasis were identified accurately 94% of the time.

The new, gene-based technology of the GeneSearch test allows for the analysis of 50% of the sentinel node, versus 5% of tissue typically examined under a microscope for evidence of cancer cells. Test results from GeneSearch can be produced in 35 to 40 minutes during the initial surgical procedure versus two to three days with tissue pathology, Veridex said.

"The GeneSearch BLN Assay offers a new approach to sentinel node testing," said Daniel Schultz, MD, director of the FDA’s Center for Devices and Radiological Health. "Results of this rapid test are available while patients are on the operating table, providing a way for some women to avoid a second operation."

Most of the women were also studied to compare the BLN Assay with immediate microscopic examination during surgery. According to the FDA, the test gave fewer false negative results, but slightly more false positive results. A false negative test result, when the cancer has actually spread, may delay the needed removal of additional lymph nodes. A false positive test, indicating metastasis when there is none, may result in a more extensive surgery and puts the women at risk of unnecessary lymphedema (swelling due to fluid build-up following lymph node removal) and other side effects.

"There is no perfect test out there but this is just another step forward … science and medicine continue to take steps forward that gets us to a better place in terms of having a correct diagnoses," Dnistrian said. Given its level of accuracy, Veridex said, GeneSearch has the potential to prevent the need for costly and traumatic second surgeries for as many as 5,200 additional breast cancer patients in the U.S. each year.

Veridex said it would initiate two post-approval studies on the GeneSearch BLN Assay. The first study will further substantiate the turnaround time of the test when used intra-operatively, the company said. An additional study, which will involve more than 1,000 patients, will further validate the accuracy of GeneSearch BLN. Dnistrian said, "We want to make sure we are getting the best and most accurate test results possible."

Elsewhere in the product pipeline:

Angiotech Pharmaceuticals(Vancouver, British Columbia) reported the completion of enrollment in its central venous catheter (CVC) pivotal study, which is designed to examine the safety and efficacy of Angiotech’s 5-Fluorouracil (5-FU) coated CVC in preventing bacterial catheter colonization when compared to another leading anti-infective CVC. CVC’s are usually inserted into critically ill patients for extended periods of time to administer fluids, drugs, and nutrition, as well as facilitate frequent blood draws. One of the complications associated with CVC implantation is infection, which can occur when bacteria contaminate the catheter. CVC infections that progress to bloodstream infections, or septicemia, can become life threatening. The principle behind using 5-FU — an approved anti-cancer drug — is that the drug appears to effectively interrupt the colonization of an implanted medical device by those micro-organisms that typically gain entrance to the bloodstream via the local skin penetration of implanted catheters. This reduction in colonization by bacteria may have a net effect of reducing biofilm burden on the implanted catheters, making them less likely to serve as reservoirs for additional infection. 5-FU has also been shown to inhibit the proliferation of a number of bacterial species directly which may be a second source of efficacy in preventing catheter-based infections. Angiotech is a specialty pharmaceutical and medical device company.

ARC International (St. Albans, England) reported that CVRx (Maple Grove, Minnesota) has chosen a member of the configurable ARC 600 core family to drive its Rheos Baroreflex hypertension therapy system. CVRx chose a configurable ARC core because of its very small size, ability to operate using extremely low power, and long-term reliability — all key criteria for “deeply embedded” organic applications, it said. The Rheos system from CVRx is believed to reduce blood pressure by using the human body’s natural blood pressure regulation system (the baroreflex). The system electrically stimulates the baroreflex, which sends signals to the brain suggesting a blood pressure increase. Then, the brain acts to lower blood pressure by sending signals to various parts of the body, including the blood vessels, heart and kidneys. The Rheos includes a small pulse generator that is implanted under the collar bone, two thin leads that are wrapped around the left and right carotid arteries, and a programmer system. CVRx makes implantable medical devices. ARC International makes configurable media subsystems and CPU/DSP processors.

ArthroCare (Austin, Texas) said it has received FDA clearance for its Cavity SpineWand to reduce malignant lesions within the vertebrae. The Cavity SpineWand is used in a minimally invasive, surgical procedure to actually remove malignant tissue within vertebrae, creating a small cavity. Medical grade cement can then be injected into the cavity, stabilizing the fracture. This procedure does not eliminate other therapeutic options for the patient such as radiation or chemotherapy. Skeletal metastases, commonly referred to as spine tumors, are caused when breast, prostate or other primary cancers spread by the bloodstream to the spine, causing vertebrae to weaken and collapse. VCFs can create debilitating back pain, impaired mobility and in some cases, paralysis. In addition to decreasing quality of life, the pain caused by VCFs may make it difficult for many patients to receive their chemo or radiation therapies prescribed by their oncologists. The wand is inserted through the cannula under radiographic guidance and is activated once it reaches the tumor. A small, highly localized plasma cloud removes tumor material while minimizing damage to surrounding healthy tissue. ArthroCare specializes in minimally invasive surgical products.

AtriCure (West Chester, Ohio) reported that its Isolator bipolar ablation clamp system has received FDA clearance for the ablation of cardiac tissue. AtriCure believes that theirs is the only bipolar radio frequency clamp system that has been cleared by the FDA for the ablation of cardiac tissue. “The AtriCure team is pleased to have achieved this major milestone. This expanded indication reaffirms our leadership position in our rapidly growing markets,” said David Drachman, president/CEO. “Furthermore, we continue to make significant progress toward obtaining an atrial fibrillation indication for our Isolator ablation clamp and pen systems. We look forward to continuing to make important contributions toward improving and preserving human life.” AtriCure makes cardiac surgical devices designed to create precise lesions, or scars, in soft and cardiac tissues.

Boston Scientific (Natick, Massachusetts) reported the launch of the Precision Plus spinal cord stimulation system (SCS), a rechargeable SCS neuromodulation device for the treatment of chronic pain of the trunk, back and limbs. Precision Plus provides physicians with EGL scan, the first and only SCS lead scanning technology. The Precision Plus system also features an improved remote control and charger to simplify control of patient therapy. EGL scan (electronically generated lead scan) technology displays the relative position of implanted leads, within seconds and without using fluoroscopy or x-ray. The information from EGL Scan can be used to increase programming accuracy, which can lead to improvements in patient outcomes and treatment office operating efficiencies. One in five Americans suffers the effects of chronic pain, and approximately five million people may be candidates for SCS therapy.

Cerner (Kansas City, Missouri) said that Cerner Bridge transfusion administration and specimen collections software solution has received FDA pre-market notification clearance. The software uses barcode scanning technology, wireless networks and clinical systems integration to improve patient safety. Utilizing positive patient identification, the solution records and collects information at the bedside and facilitates compliance with standards. Cerner supplies healthcare technology.

CryoCath Technologies (Montreal) said that data on the company’s Arctic Front catheter system to treat atrial fibrillation (AF) was presented at the European Society of Cardiology (Europace) Conference in Lisbon, Portugal. Arctic Front is a minimally invasive cryo-balloon catheter designed specifically to treat AF. This bi-directional, double balloon catheter enables physicians to rapidly isolate all four pulmonary veins for the treatment of AF. Approved in Europe, it has treated more than 750 patients in more than 24 centers. CryoCath specializes in cryotherapy products to treat cardiovascular disease.

CSMG Technologies (Corpus Christi, Texas) reported that its subsidiary, Live Tissue Connect, has filed a 510(K) submission with the FDA for a vessel and duct sealing electrosurgical generator and two sealing instruments. CSMG is a technology management company focused on commercializing human live tissue bonding devices.

DePuy Mitek (Raynham, Massachusetts) reported the launch of the VAPR S50 Radiofrequency Electrode. The VAPR S50 uses radio frequency energy to smooth tissue and eliminate jagged edges resulting from the surgical removal of soft tissue in the knee or shoulder. It is designed to ablate soft tissue and remove debris, fluid and heat (suction), as well as seal blood vessels while minimizing damage to surrounding tissue and increasing visualization during arthroscopic surgery. The device is designed to offer surgeons optimal access to the tight anatomy of the knee or shoulder. At its default setting, the VAPR system provides sufficient power for controlled ablation including meniscal sculpting. Surgeons can adjust the wattage for aggressive tissue removal including ACL debridement, notchplasty or general tissue ablation. DePuy Mitek, a Johnson & Johnson (New Brunswick, New Jersey) company, makes surgical sports medicine and soft tissue repair devices.

Dynatronics (Salt Lake City) reported that it has begun shipping the new Dynatron X5 soft tissue oscillation therapy unit. The X5 creates an electrostatic field within the patient, resulting in a highly effective treatment for pain. Dynatronics expects to announce a return to profitability in the fourth quarter ended June 30, 2007 as a result of the X5 introduction. Dynatronics develops advanced-technologymedical devices, orthopedic soft goods and supplies, treatment tables and rehabilitation equipment for the physical therapy, pain management, sportsmedicine, chiropractic, podiatry, plastic surgery, dermatology and other related medical, cosmetic and aesthetic markets.

Encision (Boulder, Colorado) said that it will begin to make its own disposable scissor inserts. “Sales of our disposable scissor inserts represent approximately 50% of our sales and we believe that we will be able to achieve a major cost reduction by producing our own disposable scissor inserts,” said Jack Serino, president/CEO of Encision. “We also expect to provide better control over the quality and consistency of this significant product line. By owning the process and manufacturing expertise for our disposable scissor inserts, we believe that we will add intrinsic value to Encision.” Encision makes surgical devices that allow surgeons to optimize technique and patient safety during a broad range of minimally invasive surgical procedures.

EXACT Sciences (Marlborough, Massachusetts) reported the publication of a study which concluded that patients who are educated about, but inexperienced with, the various colorectal cancer (CRC) screening methods prefer stool-based DNA technology (sDNA) over other non-invasive methods. In the study, 263 subjects were educated about six CRC screening tests: colonoscopy, flexible sigmoidoscopy, FOBT, flexible sigmoidoscopy plus FOBT, double contrast barium enema and sDNA. The authors concluded that average risk patients who are inexperienced with screening prefer sDNA among non-invasive options and prefer colonoscopy, overall, due to its effectiveness. Importantly, the study also showed that most patients value a shared decision-making process with their physician when it came to test selection. Finally, the authors found that because colonoscopy and stool-based tests, particularly sDNA testing, are preferred over other options, it suggests that provider-patient decision making can be tailored to include fewer options. Among the tests evaluated, patients preferred colonoscopy, sDNA and FOBT by a wide margin over all other options. EXACT Sciences uses applied genomics to develop patient-friendly screening technologies for use in the detection of cancer.

The International Society on Thrombosis and Haemostasis (Geneva, Switzerland) and Dade Behring (Deerfield, Illinois) introduced a next-generation D-dimer coagulation test, Innovance D-dimer, in Europe, Canada, and the Middle East and Asia Pacific regions. The Company also anticipates introducing a similar test in the United States in the future. The Innovance D-dimer test has a validated sensitivity for exclusion of deep vein thrombosis (DVT) and pulmonary embolism conditions associated with blood clots in the human circulatory system. The test benefits clinical laboratories of all types and sizes because it is a fully automated test that can be run on multiple coagulation systems offered through Dade Behring. “By using a simple blood test to help diagnose a patient with a possible blood clot, physicians are able to more quickly initiate proper treatment,” said Jim Reid-Anderson, president/CEO, Dade Behring. “One of Dade Behring’s priorities is to develop new tests such as this one, which assist healthcare providers around the world in offering differentiated care to their patients.” DVT and PE are serious medical conditions, affecting millions of people worldwide every year. DVT is caused by the formation of a blood clot in the deep veins of the legs, pelvis or upper extremities, leading to either partially or completely blocked circulation. PE occurs when a clot breaks loose and travels to pulmonary arteries. Both conditions could cause death if they are not diagnosed and treated properly. Studies have shown that measurement of D-dimer may also be valuable in the evaluation of rethrombosis risk, to monitor potential coagulation disorders in pregnancy, and as an aid in the diagnosis of disseminated intravascular coagulation. Dade Behring continues to evaluate Innovance D-dimer for these potential clinical indications.

Technologies (Northvale, New Jersey) reported that it has completed enrollment in its clinical trial using the company’s pulsed electromagnetic field (PEMF) technology to treat patients with ischemic cardiomyopathies. The institutional review board (IRB)-approved clinical trial at the Cleveland Clinic is designed for cardiac patients who are not candidates for surgical intervention such as angioplasty, stenting or cardiac bypass surgery. The trial looks at the use of Ivivi’s PEMF technology over a period of five months on patients with ischemic cardiomyopathy, a heart condition characterized by decreased blood flow to the heart. The primary endpoint is the improvement in regional myocardial perfusion (the flow of blood through the heart) and function as seen with a 64-slice computed tomography (CT) Scan. The secondary endpoint is patient improvement for angina and exercise tolerance. Ivivi Technologies specializes in non-invasive electrotherapeutic technology.

K2M (Leesburg, Virginia) reported the launch of its Range spinal system. This system combines the newest versions of the MESA and DENALI spinal systems and includes instruments designed to enhance the surgeon’s ability to address complex spinal pathologies such as scoliosis, which is a deforming or abnormal curvature of the spine. The RANGE spinal system is designed to provide surgeons with the ability to make an array of inter-operative decisions for spinal correction based on both the patient’s pathology and the instruments and implants the system offers. RANGE includes the next profile MESA locking technology, as well as the DENALI set screw based system that enables surgeons to address both upper and lower back surgeries. Newer instruments were also added to the combination to make treating complex pathologies a faster, easier and more efficient process when addressing pediatric, adolescent and adult patients. K2M is a spinal device company that develops simplified solutions for the treatment of complex spinal pathologies and procedures.

Medtronic (Minneapolis) said that a review of data from the ENDEAVOR IV clinical trial indicates that the trial has met its primary, non-inferiority endpoint. The trial is evaluating the safety and efficacy of the Endeavor drug eluting coronary stent as compared to the Taxus paclitaxel-eluting coronary stent system from Boston Scientific. ENDEAVOR IV has a primary endpoint of target vessel failure (TVF — a composite of cardiac death, myocardial infarction and target vessel revascularization) at nine months. Medtronic will submit these data to the FDA in support of the Endeavor pre-market approval (PMA) application. Medtronic specializes in alleviating pain, restoring health, and extending life.

• A study published in the June issue of Journal of Alzheimer’s Disease demonstrates the accuracy and validity of a new mathematics-based memory assessment developed by Medical Care (Irvine, California) to detect early signs of memory impairment due to Alzheimer’s disease and other related disorders, according to the company. The assessment, called the MCI Screen, outperformed two of the most widely used pen-and-paper tests and its accuracy helps justify the importance of regular memory assessments of people over 65 by primary care physicians, according to the study’s authors. The MCI Screen, a computer-based memory assessment, was 96% accurate in detecting impaired patients, while the MMSE was 72% accurate and the CDT 57%. The MCI Screen detected memory disorders from a variety of conditions ranging from Alzheimer’s disease (43%) to cerebrovascular disease (36%) to depression (3%). Of the 254 patients assessed, 20% were found to have underlying medical conditions. However, two-thirds had no subjective complaints of impairment and would not have received medical attention if they had not been screened for memory loss. Medical Care makes comprehensive dementia care products for healthcare professionals.

Medical Informatics Engineering (Fort Wayne, Indiana) reported the addition of the Physician Quality Reporting Initiative (PQRI) module to its Webchart electronic medical record system. This module automatically generates the data required for the PQRU voluntary program administered by the Centers for Medicare & Medicaid Services, making it easier for practices to qualify for the 1.5 percent PQRI bonus payment. The WebChart PQRI module was developed with significant physician input. As patient encounters are documented, WebChart automatically populates the PQRI module based on 74 unique measures identified by CMS for the 2007 PQRI program. WebChart also makes it easy to document allowable performance exclusions. The WebChart PQRI module then generates specific CPT II quality-data codes associated with each measure, which are submitted as part of each claim. MIE delivers customized EMR, RIS/PACS, and medical-document management solutions designed to support and improve practice workflow.

MedAir (Delsbo, Sweden) reported the launch of its OxyCheck fingertip pulse oximeter, a monitoring device that performs measurement of oxygen saturation and pulse rate. According to the company, its features include; durability, the ability to fit a range of finger sizes from pediatric to adult, and use of standard AAA batteries. The device also passes IPX2 testing against water ingress. MedAir makes widescreen capnography and pulse oximetry technologies.

Mentor (Santa Barbara, California) reported the market launch of NeoForm dermis. NeoForm is processed by Tutogen Medical (Alachua, Florida), and is a solvent-dehydrated, gamma-irradiated preserved human allograft dermis that is used in breast reconstruction procedures for women who have undergone a mastectomy. The addition of NeoForm complements Mentor’s line of high-quality breast reconstruction products, and it provides physicians and patients with another option that can help outcomes and satisfaction. Mentor makes aesthetic medical products.

Nonin Medical (Minneapolis) reported FDA clearance of the LifeSense capnograph/pulse oximeter. LifeSense combines capnography and pulse oximetry into one device. Key features of LifeSense are its Widescreen LCD display, portability and light weight. Like Nonin oximeters, the LifeSense capnograph comes equipped with Nonin’s PureSAT technology. PureSAT is designed to enable accurate readings and rapid response time. The LifeSense is intended for use in settings such as acute care, emergency medical services, intensive care units and during procedural sedation. Nonin also offers this capnography (EtCO2) technology to OEM (original equipment manufacturers) with the MaCO2 board. Nonin Medical is a privately owned company specializing in physiological monitoring solutions.

Novadaq Technologies (Toronto) reported the results of the first clinical experience utilizing the Helios fluorescence imaging system. The study confirmed that the use of intra-operative real-time laser-assisted fluorescent imaging during free-flap breast reconstructive surgery may result in improved intra-operative decision making for surgeons performing complex plastic surgery procedures and ultimately positively impact procedural outcomes for patients. Novadaq also reported that results from a pilot study of the use of the Luna imaging system during surgery for kidney cancer were recently presented at the 2007 annual meeting of the American Urological Association. The study included detailed analysis of images obtained using the Luna system during 10 kidney cancer surgeries. Results showed that LUNA allowed surgeons to differentiate between healthy and malignant cancerous tissue which enabled more precise removal of the malignant tissue while preserving as much healthy tissue as possible. A critical factor in the future health of cancer patients. Novadaq makes real-time medical imaging systems and image guided therapies for the operating room.

Novartis (East Hanover, New Jersey) reported that the Exelon Patch (rivastigmine transdermal system) has received its first approval in the U.S. as a way to deliver medicine for mild to moderate Alzheimer’s disease patients through a skin patch instead of an oral capsule. This therapy is the first transdermal treatment for this degenerative condition affecting millions of people in the U.S. Exelon Patch offers treatment based on placebo-controlled clinical trial results showing benefits to patients in terms of their memory and overall functioning. The patch maintains steady drug levels in the bloodstream, improving tolerability and allowing a higher proportion of patients to receive therapeutic doses compared to the capsule form of the medication. It is applied to the back, chest or upper arm, and provides smooth and continuous delivery of medication through the skin over 24 hours. Gastrointestinal side effects are commonly seen with this class of drugs called cholinesterase inhibitors. The recommended dose of Exelon Patch greatly reduces these side effects, with three times fewer reports of nausea and vomiting than with the capsule form of the drug. Exelon Patch is indicated for the treatment of mild to moderate dementia of the Alzheimer’s type and mild to moderate dementia associated with Parkinson’s disease. Exelon Patch is contraindicated in patients with known hypersensitivity to rivastigmine, other carbamate derivatives or other components of the formulation. Novartis Pharmaceuticals makes prescription drugs used to treat a number of diseases and conditions, including those in the cardiovascular, metabolic, cancer, organ transplantation, central nervous system, dermatological, gastrointestinal and respiratory areas.

OmniGuide (Cambridge, Massachusetts) reported the commercial availability of its OtoBeam flexible CO2 laser fiber and intuitive handpiece product line for use in otology procedures. The clinical benefits of CO2 laser energy, namely precision cutting and coagulation with minimal thermal spread, previously had limited applications in otology due to the absence of a flexible delivery system, the company said. OmniGuide’s flexible CO2 laser fiber product for the first time allows this beneficial energy source to be placed at the surgeon’s fingertips for accurate control when operating on the delicate structures of the middle and inner ear, the company said. The company said CO2 laser energy has been established as a precise and safe laser wavelength due to rapid absorption by the water-like perilymph present in the inner ear, resulting in minimal thermal spread. These characteristics make the CO2 laser a desirable tool in stapedectomy procedures. OmniGuide specializes in products to assist otology, laryngology, head and neck surgery, and pulmonology procedures for which there is the potential to damage delicate untargeted structures.

Omni-Tract Surgical (St. Paul, Minnesota) reports the introduction of their new GhosTract radiolucent retractor kit. These blades are designed to retract tissue during anterior lumbar spine procedures. Because these procedures access the spine via an incision in the patient’s abdomen, retractors must be used to maintain a pathway to the spine. The most commonly used retractors are stainless steel, which blocks the intra-operative imaging necessary during these procedures. GhosTract retractor blades are designed to be translucent, allowing the X-ray to “see through” the retractor blades. Omni-Tract Surgical makes table-mounted surgical retractors.

Omrix Biopharmaceuticals (New York), a fully integrated biopharmaceutical company that develops and markets protein-based biosurgery and passive immunotherapy products, reported the FDA approved the company’s use of Cryoprecipitate from Talecris Biotherapeutics (Research Triangle Park, North Carolina). Cryo is a plasma fraction containing coagulation proteins and the raw material from which Omrix manufactures BAC, the fibrinogen component of its marketed fibrin sealants, Evicel and Quixil, and Omrix’ Fibrin Patch, a biological-device convergence product candidate that addresses severe bleeding, an unmet medical need. The company’s passive immunotherapy product line includes antibody-rich products and product candidates for the treatment of immune deficiencies, infectious diseases and potential bio-defense applications. Omrix Biopharmaceuticals develops protein-based biosurgery and passive immunotherapy products.

Reliant Technologies (Mountain View, California) reported that its Fraxel re:pair laser system has received FDA clearance for ablation, coagulation and skin resurfacing, based on ongoing results from two rounds of clinical trials. The system provides fractional deep dermal ablation (FDDA) treatment, which leads to tissue contraction, tightening and collagen remodeling. The Fraxel re:pair laser removes aged and damaged skin without the prolonged downtime and adverse reactions associated with conventional ablative resurfacing lasers (also known as CO2 or erbium YAG lasers) and surgical procedures. The company says that the Fraxel re:pair laser combines benefits of conventional CO2 resurfacing with the safety of fractional photothermolysis. Reliant Technologies makes fractional resurfacing and aesthetic laser skin treatment.

Sequenom (San Diego) and Lenetix Medical Screening Laboratory (Mineola, New York) reported that Lenetix has submitted a clinical package to the New York State Department of Health to support its application for a clinical laboratory permit to perform a non-invasive prenatal Rhesus D (RhD) incompatibility test, the first non-invasive prenatal test based on Sequenom’s Fetal Nucleic Acid Technology. Lenetix’s RhD application of Sequenom’s fetal nucleic acid technology detects a fetus’ RhD status from the mother’s blood sample without invasive procedures that typically pose risk to the health of the mother and baby in utero. Lenetix makes genetic screening and diagnostic testing products.

Small Bone Innovations (SBI; Miami) reported that its Artelon CMC spacer arthro has been cleared by the FDA for marketing. The product is an extension of SBI’s line of implants to treat a common complaint: osteo-arthritis (OA) in the base of the thumb. The Artelon CMC spacer arthro was designed to allow minimally invasive, arthroscopic implantation in the joint between the first metacarpal and the trapezium. By avoiding violation of the joint capsule, the procedure may offer significant advantages to surgeons and their patients such as joint stability, faster recovery and less pain. SBI specializes in the small bone and joint market in the orthopedic industry.

Surgical Information Systems (SIS; Atlanta) and Materials Management Microsystems reported the first successful implementation of a bidirectional interface between SIS’ perioperative software solution and the SPM sterile processing information system. The new interface ensures consistency between instrument set descriptions in SPM and in SIS’ preference cards, and provides real-time information on instrumentation requirements necessary for supporting the OR schedule. Efficient and compliant instrument delivery, coordinated with the scheduling function, is an essential component of a streamlined operating room. And because the OR generates the largest revenues and costs in most hospitals, an effective and intuitive interface is of importance. SIS provides surgery management solutions. Microsystems provides bar code driven sterile processing management information systems.