• CytoCore (Chicago) said that FDA has approved the company’s 510(k) application 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.”

• Healthcare Providers Direct (Lawrenceville, New Jersey) reported the release of ImmunoDip, a rapid screening test to detect microalbuminuria, an early indicator of chronic kidney disease in diabetic patients. Microalbuminuria occurs when a malfunctioning kidney leaks small amounts of albumin into the urine. Sometimes early kidney damage can be reversed, making early diagnosis critical. ImmunoDip can detect as little as 18 mg/l of albumin in the urine. Microalbuminuria is indicated at 20-30 mg/l. With ImmunoDip, physicians can complete the test in their office with a negative or positive indication within three minutes. Healthcare Providers Direct makes rapid diagnostic tests.

• Ikonisys (Dallas) said that it has begun a clinical trial evaluating its breakthrough test for early detection of chromosomal abnormality trisomy 21. Early, non-invasive detection of genetic disorders, including Down syndrome, provides pregnant women with fast and accurate solutions that eliminate the need for repeat testing. The trial is intended to establish accuracy and efficacy in the detection of trisomy 21 in circulating fetal cells. Ikonisys expects this solution to be the first in a suite of non-invasive cell-based fetal tests. Ikonisys makes non-invasive, cell-based diagnostic solutions.

• Medtronic (Minneapolis) reported FDA approval of a new physician-use continuous glucose monitoring (CGM) system, the CGMS iPro Recorder. Physicians send patients home with the CGMS iPro to uncover patterns and potential problems that often go undetected with today’s standard glucose measurements like finger stick meters and HbA1c tests. Patients wear the CGMS iPro Recorder for three days, after which physicians can review the data and use the results to uncover glucose patterns and optimize patient therapy. The iPro is attached to a small glucose sensor inserted just under the skin. During the course of three days, the recorder automatically measures and stores glucose values during daily activities like work, sleep, eating, and exercise. After the recording period is completed, the patient returns to the physician’s office where the device is removed and downloaded. Medtronic specializes in a number of medical technology devices.

• 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.

• Siemens Medical Solutions’ Oncology Care Systems unit (Concord, California) received FDA clearance for the sale and distribution of its most recent innovation in radiation therapy technology, the Artiste solution. The Artiste is 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.

• Smiths Medical ASD (Rockland, Massachusetts) said it has received FDA clearance for its Saf-T closed blood collection system for use in syringe blood draw and transfer applications. Configurations address winged vein access as well as Luer access to a newly placed peripheral IV catheter. The Saf-T is similar in design to Saf-T Wing blood collection set, but accommodates either a male Luer connector or a Saf-T Wing to access the vein. Both configurations use a female Luer connector for sample syringe attachment. The company said the Saf-T devices require minimal manipulation of the Luer connectors once the initial set up is completed, resulting in lower risk for sample contamination. Smiths Medical specializes in safety devices, vital care and medication delivery & patient monitoring.

• T2 Biosystems (Cambridge, Massachusetts) reported significant research findings that support the advancement and development of nanoparticle-based, magnetic resonance technology that offer rapid, portable diagnostic testing. This new research demonstrates new methods of advancing and developing magnetic resonance-based diagnostics that offer improved speed, accuracy and efficiency as well as portability to a broader range of settings including doctor’s offices, homes and hospitals. These findings show the feasibility of T2’s portable diagnostic system, building on dozens of prior published research studies by scientists demonstrating the ability of the nanoscale MR-based technology to detect target substances in diagnostic tests, including small molecules, single viral particles, bacteria and cancer biomarkers. T2 biosystems makes portable diagnostic products.

• Toshiba America Medical Systems (Tustin, California) reported FDA clearance for its new open-bore 1.5T vantage titan MR system. The company said the open-bore of the titan is 18% larger than other 1.5T systems on the market, featuring a large 71-centimeter patient aperture. The system features Toshiba’s Pianissimo noise reduction technology, which creates a better imaging experience for all patients. The titan also takes advantage of Toshiba’s contrast-free MRA techniques – fresh blood imaging, contrast-free improved angiography, time-spatial labeling inversion pulse, and time-slip angiography. Toshiba America Medical makes magnetic resonance technology.