Cleveland BioLabs, Inc. announced that the first healthy volunteers have been dosed in the second human safety study for CBLB502, a drug under development for the treatment of Acute Radiation Syndrome (ARS). CBLB502 is being developed by Cleveland BioLabs under the FDA’s Animal Efficacy Rule to treat Acute Radiation Syndrome (ARS) or radiation poisoning from any exposure to radiation such as a nuclear or radiological weapon / dirty bomb, or from a nuclear accident.

For the full story, Click Here

SonoSite’s NanoMaxx ultrasound system has just received FDA approval. The NanoMaxx system relies on SonoSite’s advanced proprietary imaging algorithms, including SonoMB and SonoAdapt to offer superior image quality in a lightweight, rugged form factor. Since it is fully portable, it can be used in several places including busy clinics, ambulances, emergency rooms and other places where ultrasound is required.

The FDA has announced the release of a draft guidance entitled “The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System 13.” The document is aimed at providing the FDA’s current view on the final regulations implementing the Mammography Quality Standards Act of 1992 MQSA) to the mammography facilities and their personnel. Some of the points addressed in the draft guidance are:
•    General guidance regarding Additional Mammography Reviews (AMRs)
•    Previously approved alternative standards
•    Labeling of mammographic images
•    Mammographic modality and its impact on personnel experience requirements

The University of Illinois at Chicago recently unveiled this new generation magnetic resonance imaging (popularly called MRI) machine, which has a magnetic field strength more than three times that of the state-of-the-art clinical units. The world’s most powerful MRI can detect brain tumors and diseases such as Alzheimer’s even before actual symptoms appear. The FDA has approved the use of the device for certain research projects.

NeuroLogica Corporation has received the 510(k) clearance from the FDA for the SPECT (single photon emission computed tomograph). The inSPira HD is a mobile system that runs on batteries and can be moved around hospital wards if necessary. Image quality of inSPira HD is close to that of PET with the resulting reconstructed spatial resolution as high as 3.0mm. inSPira HD is capable of imaging all available neuro radiotracers offering a broad range of clinical applications including Epilepsy, Parkinson’s, Stroke and Alzheimer’s.

SuperSonic Imagine has received 510K clearance from the FDA for its Aixplorer(TM) ultrasound system. Aixplorer is the only commercially available system of its kind with MultiWave(TM) Technology, which is based upon interaction between conventional longitudinal waves and shear waves in tissue. The system displays tissue stiffness or elasticity information using shear waves. As stiffness is an additional parameter which characterizes tissue, Aixplorer brings clinicians significantly enhanced diagnostic information.

With the US facing erratic availability of this technetium-99m’s feedstock, molybdenum-99, the FDA is advising physicians to consider substituting sodium-fluoride positron emission tomography, also known as NaF-18 PET imaging. However, this PET bone imaging test would not be covered by Medicare. Although the five medical societies have petitioned the federal Centers for Medicare & Medicaid Services (CMS) to alter its PET-exclusion policy, no decision is expected till March 2010.

The FDA has approved a new trauma device in which FISO Technologies Inc’s fiber optic sensor is a key element. FISO expects the device to be released to the markets in the forthcoming months. Fiber optic temperature probes are insensitive to radio frequency and microwave radiation and can, therefore, be used in MRI machines without affecting the image clarity.

Hologic has received approval from the Food & Drug Administration (FDA) for R2 DigitalNow HD software that allows radiologists to improve the analysis of mammograms. Marketing director Jim Culley said that a large number of screening sites in the US use analog photographs, which can lose image quality when they are digitized. R2 DigitalNow HD can digitize older film-based mammograms, while retaining image quality.

The U.S. Food and Drug Administration has granted the 501(k) clearance to Aurora Imaging Technology Inc.’s Aurora® 1.5Tesla Dedicated Breast MRI System for AuroraSPECTROSCOPY™, the company’s package of breast magnetic resonance (MR) spectroscopy. The package was developed as an add-on for the Aurora Breast MRI in order to enhance the image specificity of this innovative technology. It continues to be the only dedicated breast MRI system cleared by FDA which is specifically designed to detect, diagnose and manage breast disease alone.