Bionik Completes Interactive Motion Buy
Bionik Laboratories has finalized its acquisition of Interactive Motion Technologies, a developer of robotic tools for neurorehabilitation. The Toronto-based devicemaker will gain all of IMT’s outstanding shares, assets and liabilities. Bionik’s pipeline now will include three upper extremity clinical rehabilitation products, a lower-body product and other candidates in the pipeline.
FDA Clears Vevo MD Ultrasound System
A Fujifilm SonoSite subsidiary has garnered clearance for its ultra-high frequency ultrasound Vevo MD, which delivers image resolution down to 30 mm. The system is compatible with the company’s transducer technology that can generate frequencies up to 70 MHz, an increase in resolution versus traditional ultrasounds, according to the company.
Ortho Kinematics Nabs CE Mark
Ortho Kinematics has earned CE marking for its Vertebral Motion Analysis diagnostic test, intended to assess spinal motion and radiographic instability. The test increases sensitivity in the detection of radiographic instability with no reduction in specificity versus the standard test. The company plans to begin marketing in the UK later in the year.
EMBLEM S-ICD Systems Gets CE Mark
Device giant Boston Scientific has been granted CE marking for its Emblem MRI subcutaneous implantable defibrillator system, along with magnetic resonance conditional labeling for all implanted Emblem S-ICD systems. The system is designed to minimize the risk of complications linked to transvenous implantable cardioverter-defibrillators in patients at risk of sudden cardiac arrest that leaves the heart and vasculature unharmed. A full European launch is expected early this summer, the company says. The product is not available in the U.S.
Bill Aims to Amend CMS Process
A lawmaker has proposed legislation that would streamline Medicare coverage for technologies approved through the FDA’s medical device expedited review process. Rep. Charles Boustany (R-La.) introduced the bill, which would allow any new FDA-approved device or diagnostic labeled as a breakthrough to receive transitional coverage for a three-year period by CMS. During this time, the therapy would receive reimbursement, and CMS could specify, if necessary, additional data that would be needed for continued coverage after the three-year period.
FDA Greenlights Nevro Leads
The FDA has approved Nevro’s new surgical leads, which are intended for use with Senza Spinal Cord Stimulation, a neuromodulation platform delivering HF10 therapy. The SCS therapy system delivers electrical pulses via a compact battery-powered generator implanted under the skin located near the spinal cord to treat chronic leg and back pain.
Toshiba’s Aquilion Lightning CT Cleared
Toshiba America Medical Systems has gained FDA clearance for its Aquilion Lightning CT system for routine volumetric scanning. The 16-detector row system features ViSION CT detector technology and AIDR 3D Enhanced to minimize dosage and enhance patient safety, according to the company.