Mevion Medical wins FDA 510(k) clearance for Mevion S250 proton therapy systems
Toshiba
FDA clears Ethicon’s 1st surgical set docs can assemble inside the body | Regulatory Roundup
Johnson & Johnson (NYSE:JNJ) Ethicon Endo-Surgery won FDA clearance for the 1st surgical instruments that can be assembled and disassembled inside the body during surgery.
Abbott, St. Jude Medical re-up ‘cardiovascular alliance’ | Wall Street Beat
Ortho market growth stable but low | Wall Street Beat
The market for hip and knee implants is stable but mired in a low-growth stage, according to analysts who attended the American Academy of Orthopedic Surgeons conference in San Francisco last week.
Although the abrupt departure of Stryker CEO Steve MacMillan drew the lion’s share of attention at the AAOS event, analysts from Barclays Capital and Leerink Swann agreed that the sector’s outlook calls for low-single-digit growth.
Toshiba lands 510(k) for latest Aquilon CT scanner | Regulatory Roundup
Toshiba’s (TYO:6502) American medical products division won 510(k) clearance from the FDA for the latest iteration in its Aquilon line of CT scanners.
The Aquilon Prime is designed for healthcare facilities that need to perform a wide variety of advanced clinical examinations with reduced radiation exposure, according to a press release.
Boston Scientific lauds NICE results from the U.K. | Regulatory Roundup
Boston Scientific Corp. (NYSE:BSX) lauded a new guidance released by the research arm of the U.K.’s National Health Service, the country’s publicly funded health care system.
The National Institute for Health & Clinical Excellence issued a final guidance for bronchial thermoplasty as an option for patients with severe asthma that isn’t controllable with drugs, a boon for Boston Scientific’s Alair.
Steris and Toshiba collaborate on hybrid ORs
Steris Corp. (NYSE:STE) and Toshiba Medical Systems Corp. struck a deal to collaborate on creating hybrid operating room suites.
The hybrid suites allow surgical and diagnostic teams to perform open surgeries and carry out a wide range of image-guided cardiovascular, vascular and neurosurgical procedures without moving a patient from room to room.
GPOs: Novation inks MRI deal with six OEMs
Group purchasing organization goliath Novation inked six new agreements this week for MRI scanners and equipment.
Toshiba increases MR efficiency with M-Power | Regulatory Roundup
Toshiba Medical’s M-Power interface, a customizable MRI system designed to accelerate the scanning process and enhance diagnoses. M-Power will be availble for use on Toshiba’s Vantage Atlas, Vantage Titan, and Titan3T system.
The interface uses a drag and drop method that, Toshiba said, will enhance useability, allowing technicians to favorite the most frequently used scanning tools.
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Toshiba receives FDA clearance for advanced M-Power interface
Toshiba Receives FDA Clearance for Advanced M-Power Interface
Customizable User Interface Streamlines and Accelerates Imaging Process
TUSTIN, Calif.–(BUSINESS WIRE)–Increasing MR exam efficiency, Toshiba America Medical Systems, Inc.’s advanced M-Power interface has received FDA clearance. M-Power is a customizable MR system user interface enabling technologists to streamline and accelerate scanning processes and enhance diagnoses. M-Power will be available for use on Toshiba’s Vantage Atlas™, Vantage Titan™ 1.5 and Titan 3T MR systems with an upgrade path for those systems already installed.
M-Power runs the MR system, offering a simple interface for the entire imaging process. M-Power has many new enhanced efficiency tools:
Optos gains on Project Daytona FDA clearance | MassDevice.com Regulatory Roundup
Shares of Optos plc (LSE:OPTS) gained 6.4 percent after the company announced that the FDA granted 510(k) clearance in the U.S. for its Project Daytona retinal scanning device.
The British ophthalmology device maker’s stock closed at £1.62 today (about $2.64), up about 15 cents since August 25, the day before the clearance announcement, when OPTS shares closed at £1.52 ($2.49) on the London Stock Exchange.