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Mazor Robotics Spinal Deformity Correction Planning Software FDA Cleared

Picture: Mazor Robotics

Mazor Robotics Ltd. has received FDA clearance for its Mazor X Align™ software. Mazor X Align is designed to assist surgeons in planning spinal deformity correction and spinal alignment for procedures performed with the Mazor X Surgical Assurance Platform. The new software will be demonstrated during exhibit hours at the 2017 American Association of Neurological Surgeons (AANS) Annual Scientific Meeting in Los Angeles, CA, April 22-26.

Mazor X Align leverages Mazor Robotics’ extensive experience in pre-operative planning, image processing, computerized anatomy recognition, and registration of different imaging modalities. It is the latest module to be added to the Mazor X proprietary Pre-operative Analytics software suite, and enables surgeons to create a patient-specific, three-dimensional spinal alignment plan. The 3D plan simulates an entire spine, allowing pre-operative estimation of the impact of a planned surgical correction on the patient’s posture post-operatively, considering segmental range-of-motion and final alignment parameters.

According to Ori Hadomi, CEO of Mazor Robotics, “Mazor X Align is the product of Mazor’s development program and represents our innovative pipeline and visionary team experience. We are dedicated to pushing the envelope bringing to the market advanced products and applications in order to benefit an increasing number of patients suffering from difficult conditions and supporting the medical professionals serving them.”

Mazor X Align will be released to a selection of Mazor X customers in early May. This early release will be followed by a widespread release during the second half of 2017.

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Alpha Source to Strengthen Medical Equipment Service Offerings

Alpha Source announced that it has expanded its portfolio of medical equipment service offerings through a recent investment in Medical Optics. Medical Optics, a global leader of endoscope and surgical instrument repair, will operate as a business unit of Alpha Source. Together, Alpha Source and Medical Optics will continue to enhance their portfolio of solutions for healthcare customers seeking to extend the life of their medical equipment; and the patients who depend on them.

“The Alpha Source acquisition of Medical Optics is part of an ongoing growth strategy to expand our comprehensive portfolio of medical equipment parts, field service and depot repair options,” said Rick Lytle, Chief Executive Officer of Alpha Source and Medical Optics. “Medical Optics has a proven approach, focusing on rapid and flexible customer responsiveness, and we are excited to partner with the talented Medical Optics management team.”

Founded by Frank Malvasio in 1997, Medical Optics has grown into a premier, international and ISO certified endoscope repair company with a strong reputation for high quality, efficient turn-around of endoscopes and surgical instruments. “Our customers will continue to work directly with their trusted Medical Optics sales and service contacts, experiencing the same superior levels of customer service they’ve come to expect,” said Malvasio. “In addition, through commercial and supply chain partnership with Alpha Source, our ability to respond to customer needs and market growth becomes stronger.”

“The Alpha Source team is pleased by the continued operational and investment support from our private equity sponsor Baird Capital,” said Lytle. “Given the rapidly changing healthcare marketplace, hospitals and other healthcare providers will benefit from our broadening portfolio of medical equipment service offerings.”

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CFDA adjusts approval procedures for drugs and medical devices

In order to optimize the evaluation and approval procedures for drugs and medical devices, and improve evaluation and approval efficiency, China Food and Drug Administration (CFDA) recently issued The Decision of China Food and Drug Administration on Adjusting Some Administrative Approval Procedures for Drugs (CFDA Order No. 31), and The Decision of China Food and Drug Administration on Adjusting Some Administrative Approval Procedures for Medical Devices (CFDA Order No. 32), to adjust CFDA’s administrative approval procedures for the approval of clinical trials, the approval of re-registration and registration renewal, and the approval of registration alteration of drugs and medical devices.

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BD New Flow Cytometer System FDA Cleared

BD announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for a flow cytometer system with a leucocount reagent assay used in residual white blood cell enumeration.

When used together with the BD Leucocount™ kit and BD Trucount™ tubes, the new BD FACSVia™ system provides a simple solution for identifying and counting rWBCs in leucoreduced blood products.

“The BD FACSVia system provides blood banks and clinical laboratories with an easy-to-use cell analysis solution to help determine and quantify the presence of residual white blood cells in their blood products,” said John Ledek, president of Biosciences for BD. “The addition of the BD FACSVia system follows our larger strategy of making flow cytometry easier to use with improved efficiency, simplified sample analysis and high-quality diagnostic results.”

With an intuitive user interface, the fully automated BD FACSVia system improves overall lab efficiency and simplifies workflow.

The BD FACSVia system offers the performance of a full-function clinical flow cytometer but in a compact design that easily fits on a benchtop or within a hood.

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REVA receives CE Mark for bioresorbable scaffold

REVA Medical, Inc. announced that it has received CE Mark approval for its Fantom drug-eluting bioresorbable coronary scaffold, which offers multiple and substantial performance advantages over first-generation scaffolds on the market.

Fantom is REVA’s first commercial product. CE Marking allows for commercial sales in Europe and other countries that recognize the mark. With the approval, REVA will commence selling in selected centers in Europe this quarter. Initial quantities of the product have been manufactured and are immediately available to support commercialization.

Commenting on the approval, Chief Executive Officer Ms. Reggie Groves said, “CE Mark approval for Fantom is a major milestone for the Company. It is the culmination of years of effort. As the patient population becomes increasingly acquainted with the appeal of bioresorbable scaffolds in general, versus metal stents, we believe they will come to ask for Fantom by name, based on our positive data and the increasing preference for Fantom that we expect leading clinicians will develop over time.”

Data from patients enrolled in the Company’s FANTOM II clinical trial were used to support the CE Mark application. The trial enrolled a total of 240 patients between March 2015 and March 2016. The Major Adverse Cardiac Event (“MACE”) rate through six months for all 240 patients is 2.1%, which compares favorably to commercial first-generation bioresorbable scaffolds.

The Company continues to follow and evaluate patients and plans additional data releases at major industry conferences in May and October of this year. As previously announced, the Company is currently pursuing a private financing to support its commercial launch of Fantom and its ongoing operating and capital needs, including followon clinical trials and new product feasibility work. The financing is anticipated to close before month end.

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ITL to develop ground-breaking cancer imaging project

Innovative medical device contractor ITL Group has partnered with King’s College London (KCL) to develop a ground-breaking cancer imaging project.

The project, funded by the EU Horizon 2020 scheme, brings a consortium of 20 companies, including technology giants Phillips and Siemens, to exploit developments in engineering and Magnetic Resonance Imaging (MRI) to develop Magnetic Resonance Force Imaging (MRFI) for new applications in cancer diagnostics.

The project aims to address a fundamental need in planning and monitoring of cancer treatment by allowing better identification and sizing of cancer tumours.

ITL Group joined the consortium in 2015 as a medical device design, development and manufacturing partner, becoming active in 2017 once earlier elements of the project had been completed.

Re-imagining MRI for new applications could provide a non-invasive way to diagnose and measure cancer tumours. This project will produce three prototypes developed for use on brain, liver and breast cancer patients.

Picture: ITL Group

ITL Group, with 40 years of industry experience, will further develop KCL’s initial hardware design, and manufacture several prototypes, which will be presented to Harvard Medical School this summer. The hardware is an advanced vibration transducer which functions by measuring interstitial fluid pressure and cell traction forces.

The global company, with operations in UK, US and China, has taken the original three vibration transducers through a rigorous development process to improve on the initial concept.

King’s provided ITL with an initial design and brief; to make the device smaller and more compact, more aesthetically pleasing, easier to handle and with improved performance and efficiency.

ITL has made significant headway in improving the technology that can guide treatment choices in breast, liver and brain cancer patients, with prototypes ready for trials in June 2017.

ITL Mechanical Engineer, Dan Hollands, is leading the project, taking dual roles as Project Manager and Head Engineer.

For the project, ITL has been trialling a state-of-the-art 3D printer to open up the possibilities of development and experimentation. As the transducer will be used in a MRI scanner it’s necessary that all components are plastic, therefore it lends itself to the 3D printing process.

Unlike commercial projects ITL has completed over the past 40 years, this grant gives ITL free reign to experiment and innovate. Essentially the design and development process can continue to the capacity of the grant – giving Dan Hollands time to push the design to its limits.

Over the year’s ITL has collaborated with a host of leading universities in the UK.

Source: ITL Group

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