Imaging

A fine example of how problems can befall a medical product. In this case, overzealous zapping (alright, gamma irradiating) one particular lot of an X-Ray detectable swab during manufacture has had the potential effect of causing its X-Ray detectable thread to fall to pieces.

FDA approval confirms that ExAblate® MRI-guided Focused Ultrasound is effective in reducing pain from bone metastases in patients who could not undergo radiation therapy.

Brilliant idea this. Use the principle behind your in car GPS to create the map of the internal organ, then fit your insertable device with sensors so you can locate it without repeat fluoroscopy. Real time navigation with reduced radiation exposure.

Echometrix LLC has announced that it has received U.S. FDA clearance to market its EchoSoft™ ultrasound technology, which the company claims provides a new level of information from diagnostic ultrasound tests.

Toshiba America Medical Systems, Inc. has received FDA clearance for its Aquilion™ RXL Edition CT system. The Aquilion RXL reconstructs images faster and includes the latest dose reduction technologies, providing what Toshiba says is faster, safer information to physicians and patients.

Based out of Shenyang, China, Neusoft Positron Medical Systems, a joint venture between Neusoft Medical Systems Co., Ltd., and Positron Corporation has received ISO certification (9001:2008 & 13485:2003) and CE Mark approval for the Attrius® PET Systems.

Siemens Healthcare has announced that its MAGNETOM Spectra 3 Tesla MRI system has received US FDA clearance. The company believes it has achieved the optimal blend of reduced ownership costs, excellent image quality and rapid scan times with this system which it says provides hospitals and radiological institutes with easier access to 3T technology.

Imaging specialist Olea Medical, has obtained FDA 510(k) clearance to market its Olea Sphere medical imaging enterprise software package in the US.

NeuroLogica has announced the integration of NeuroLogica’s portable BodyTom™ 32-slice CT scanner with Medtronic’s StealthStation® S7® surgical navigation system.

Intrinsic Medical Imaging says its newly FDA cleared, next generation 3D capabilities will provide visualisation and quantification tools designed to improve on existing conventional 2D and 3D methods.

Smart move for Cyberonics as it spots an opportunity to tap into Imricor’s MRI-compatible lead capability for its own neuromodulation products.

NinePoint Medical, Inc., an emerging leader in the development of medical devices for in vivo pathology, has announced that it has gained CE mark approval for the NvisionVLE™ Imaging System.

Cleveland medical device company ViewRay Inc., has received U.S. FDA 510(k) premarket notification clearance for its MRI-guided radiation therapy system. The ViewRay system features what the company calls a unique combination of radiotherapy delivery and simultaneous magnetic resonance imaging (MRI) for the treatment of cancer.

Bioptigen Inc. has received FDA 510(k) clearance to begin marketing its hand-held Envisu Spectral Domain Ophthalmic Imaging System (SDOIS) for patient use. In receiving this regulatory clearance, Bioptigen’s Envisu SDOIS become the first optical coherence tomography(OCT) imaging system commercially available in the United States for hand-held and paediatric imaging.

We’re keen to keep you informed of future events in your chosen, or related specialty. To that end we’ve trawled the heart congresses taking place in the next twelve months and provided this helpful list with links.

They’re all at it… joining forces to extend sales of their own products while also sharing future NPD expenditure is medtech’s very own definition of a developing symbiotic relationship between closely related businesses.