A Medical Device Daily

Hologic (Bedford, Massachusetts), a developer of premium diagnostics, medical imaging systems and surgical products dedicated to serving the healthcare needs of women, reported that it has received the CE mark for its ThinPrep integrated imager.

The integrated imager represents the latest innovation in cervical cancer screening by combining proven ThinPrep imaging technology and slide review into a single, convenient stand-alone device. This exciting new product offering allows laboratories of all sizes to benefit from clinical advantages of ThinPrep imaging for cervical screening.

"This represents a tremendous opportunity for Hologic and our current and future laboratory partners throughout Europe," said Howard Doran, senior VP, diagnostics products for Hologic. "The ThinPrep integrated imager is designed to provide the small and medium volume laboratory access to the most effective and efficient cytology screening technology available, while allowing them the flexibility to address their specific productivity and throughput needs." The majority of laboratories in Europe would fall into the small or medium category, the company noted.

The integrated imager analyzes a ThinPrep Pap test slide in about 90 seconds, during which time each cell and cell cluster is scanned. Using optical density analysis, the integrated imager identifies diagnostically-relevant cells or cell groups and then stores coordinates of the 22 fields of interest. These 22 fields of interest are presented to the cytotechnologist for interpretation. If no abnormalities are identified by the cytotechnologist, the slide can be signed out as negative or proceed through the laboratory quality control system. A complete slide review is required if the user detects any suspicious cells within the 22 fields of view. This dual review process combines human interpretative expertise with the power of computer imaging.

The ThinPrep integrated imager is currently not approved by the FDA.

Safer auto-injector to secure regulatory approval

A novel auto-injection device designed specifically for the major class of emerging therapeutics, viscous biologic drugs, is set to gain CE marking regulatory approval in Europe by year end.

Future Injection Technologies (FIT; Oxford, UK) reported the launch of their new class of auto-injectors, designed specifically for the emerging and high growth market in injectable viscous, biologic and protein therapeutics.

The company said it has been granted an audit date and expects to secure a CE mark as a class IIa medical device by the year end and U.S. 510(k) regulatory approval following shortly after that.

Two thirds of the drugs currently in clinical trials are viscous biologics for indications including rheumatoid arthritis, multiple sclerosis and psoriasis. These are often difficult to inject because of the force required to push a viscous fluid through a fine-gauge needle so there is a significant need for injection devices that allow patients to self-inject these drugs easily.

Current devices are generally derivatives of insulin pens and many fail to cope with the forces needed to administer viscous drugs. This raises the risk of failure and the risk to patients. The SafeClick injector numbers amongst only a handful of devices that will meet emerging global needle-stick regulations likely to make needle-safe devices mandatory, the company said.

FIT has patented an active needle management solution which automatically shields the needle inside the device. The device is designed specifically for proprietary pharmaceutical and generics companies seeking delivery solutions for viscous, pegylated macromolecule and lyophilized injectables.

The auto-injector is designed to enclose a standard pre-filled syringe, lyophilized cartridge or any other pre-filled drug chamber, so that the needle is shielded within the main device rather than an outer flimsy needle shield. The drug which might be a non-viscous, viscous or lyophilized substance does not come into contact with the device. This means that because there has been no interference with the primary packaging, there is little regulatory requirement if any before product launch.

"Auto-injectors are rapidly becoming a must-have to protect franchises for injectable medicines and are becoming mandatory for pre-filled syringes, which is how many of these new biologic drugs must be administered," said Paul Whyte, MD, CEO of Future Injection Technologies.

Hospital adds MRI to diagnostic armamentarium

Staff at Musgrove Park Hospital (Taunton, UK), part of Taunton and Somerset NHS Foundation Trust, reported the installation of a Magnetom Avanto 1.5 Tesla MRI from Siemens Healthcare (Erlangen, Germany). The system has been installed in a new MRI suite in the Diagnostic Imaging department and was officially unveiled by the Trust's Chairman Ros Wyke, with consultant radiologists and members of the strategic project team also in attendance.

The installation will enable the hospital to carry out cardiac MRI for the first time and enhance neurological procedures to offer a new stroke imaging service. The system will also be used for general musculoskeletal, hepato-biliary and pelvic scanning and will help to provide additional capacity for scanning of oncology patients, to coincide with the opening of the hospital's Beacon Cancer Center. This will include whole body imaging for prostate cancer. Two spinal surgeons at the hospital are also keen to explore the potential use of the Avanto to assist in examinations of patients suffering from spinal abnormalities.

Siemens' intuitive syngo VIEWS application, powered by Tim (Total imaging matrix) technology, has also been purchased with the Avanto. syngo VIEWS provides high spatial and temporal resolution for 3-D bilateral breast imaging.

"We carried out very detailed market research on the MRI systems offered by the major healthcare providers and the Avanto was clearly well ahead," said Gillian Stapleton, Deputy Clinical Manager and MRI Project Manager at Musgrove Park Hospital. "Siemens came out on top in our tender return evaluation and its representatives were very easy to work with. Although scanning has only just started with the Avanto, we have already noticed its excellent image quality and we anticipate that its advanced coil technology will allow us to achieve a high level of streamlined workflow, patient throughput and efficiency."