A final order has been issued by the Ontario Superior Court of Justice approving Stryker's acquisition of fluorescence imaging technology maker Novadaq Technologies, valued at $700 million. The completion of the deal is still subject to approvals from US and Canadian antitrust regulators.
A round of Series D financing has brought in $13 million for Boston-based clinical-stage firm NeoSync. The proceeds will be used to fund a registration study of the company's NeoSync-EEG Synchronized TMS, or NEST, technology involving patients with treatment-resistant depression, as well as to prepare for the technology's commercial launch.
A $2.4 million exchange of outstanding warrants for 2 million new shares of common stock has been announced by InVivo Therapeutics. The warrants were issued as part of a financing deal three years ago.
A private placement of common stock and warrants involving Hong Kong-based investment group Ally Bridge LB Healthcare Master Fund could pull in $2.2 million for Biocept. Strategic options are also being discussed by the company and Ally Bridge's Chinese affiliate for leveraging the liquid biopsy platform of Biocept in China.
An agreement has been reached by JustRight Surgical with Intuitive Surgical granting Intuitive an exclusive global license to JustRight's intellectual property in energy-based tissue stapling and vessel sealing technologies for robotics. The deal includes an equity financing arrangement, as well as collaboration on product development.
J. Michael Bruff has been tapped to serve as vice president of investor relations at Varian Medical Systems. Bruff, who most recently served as senior vice president of North America sales strategy and planning at Dell, succeeds Spencer Sias.
A letter was released by the FDA alerting health care providers of seven deaths involving patients implanted with liquid-filled intragastric balloon systems, including Apollo Endo Surgery's Orbera Intragastric Balloon System and ReShape Medical's ReShape Integrated Dual Balloon System, for obesity treatment. The FDA seeks to continue its collaboration with the device makers to track possible complications, including spontaneous overinflation and acute pancreatitis, and determine the cause of deaths.
Results from a trial presented at the annual Amputation Prevention Symposium showed use of peripheral interventions, including Cardiovascular Systems' DiamondBack 360 coronary orbital atherectomy system, for treating patients with critical limb ischemia demonstrated an 81.7% rate of freedom from amputation for Rutherford Classification 6 and 96% for RCs ranging from 4 to 5 at one year. A sub-analysis also showed that at 12 months, vessel preparation using the Diamondback led to a 95.2% rate of freedom from major adverse events without major amputations.
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The FDA has given molecular diagnostics firm iCubate clearance for the iC-System and the iC-GPC assay for rapid detection of bloodstream infections-related pathogenic bacteria. The system and the in vitro diagnostic test take up to 48 hours less than other tests to deliver results, the company said.
AdvaMed is looking to use this year's remaining congressional agenda, including the reauthorization of the Children's Health Insurance Program and a tax reform package, as vehicles to end the medical device tax and is now organizing a group of industry executives to meet with members of Congress on Sept. 13. Greg Crist, a spokesman for AdvaMed, said the repeal has gained a high level of support as it is included in a House Problem Solvers Caucus plan and a proposal from Sens. Lindsey Graham, R-S.C., and Bill Cassidy, R-La.
Oct. 18 | Washington, D.C. During this interactive workshop, the FDA and industry experts will lead you through the regulatory and practical guidelines governing when an investigational device exemption (IDE) is required. Learn more.
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