Medtronic wins FDA nod for MRI-safe pacemaker lead | Becton enters next-generation sequencing market with GenCell buy | Maker of total artificial heart advances $15M funding round
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October 15, 2014
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Medtronic wins FDA nod for MRI-safe pacemaker lead
The FDA has granted Medtronic approval for its CapSureFix Novus MRI SureScan 5076 pacemaker lead. With this approval, patients who are implanted with the lead and the company's Revo MRI or Advisa MRI SureScan pacemakers can now undergo whole-body MRI scans safely. (Boston) (10/14)
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CAPA Violations Still the Top Issue for FDA:
FDA inspectors view a firm's CAPA program as an indicator of how well or how poorly a firm has a handle on its overall operations.
Business & Market Trends
Becton enters next-generation sequencing market with GenCell buy
Becton Dickinson has agreed to pay an undisclosed sum to purchase GenCell Biosystems, an Irish firm specializing in automated sample preparation technology. The deal should allow Becton to make inroads in the next-generation sequencing technology arena. GenomeWeb Daily News (free registration) (10/13)
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Maker of total artificial heart advances $15M funding round
A regulatory filing disclosed that Syncardia has obtained $6.4 million in a Series F financing round aiming for $15 million. The company is the maker of the CardioWest total artificial heart, an FDA-approved device used to reduce heart failure symptoms. (10/14)
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Mazor Robotics appoints new CEO
Christopher Prentice has been promoted from senior vice president of America and global marketing to CEO of Mazor Robotics. Prentice held leadership roles at Ethicon Endo-Surgery, a Johnson & Johnson unit, before joining Mazor four years ago. (10/14)
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International DevelopmentsSponsored By
EU nod sought by Medtronic for proposed $43B merger with Covidien
The European Commission said Medtronic has sought the approval of antitrust regulators in Europe for its pending acquisition of Covidien for $43 billion. EU regulators said a decision could be issued by Nov. 14. Reuters (10/13)
Device, drug regulatory agencies in Bulgaria, Sweden get new leaders
The Bulgarian Drug Agency has appointed Assena Stoimenova as its new executive director, while the Medical Products Agency in Sweden has tapped Catarina Andersson Forsman to serve as its director general. The European Medicines Agency said Stoimenova and Andersson Forsman became members of its management board on Sept. 30 and Oct. 1, respectively. Clinica (subscription required) (10/14)
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The 10 Commandments of Product Development
People often ask, "how can I make my design process more predictable?" In our 25 years of experience designing medical devices, we've found that you can't always predict all the twists, but there are things that can be done to increase the certainty in a successful outcome. Click here for this free e-book.
Science & Health
Collaboration aims to develop test for early TB diagnosis
Advanced Biological Laboratories has struck a development deal with two universities in Hong Kong for undisclosed terms. Under the deal, the groups will create a next-generation sequencing-based early tuberculosis detection test that works with Advanced Biological's DeepChek system, and validate the test using prospective and retrospective clinical samples. GenomeWeb Daily News (free registration) (10/14)
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Emerging Technologies
VisionCare's eye device obtains wider FDA approval
VisionCare Ophthalmic Technologies has received expanded FDA approval for its miniature telescope implant to be used in patients with end-stage age-related macular degeneration who are at least 65 years old. The agency previously approved the surgical device for use in end-stage AMD patients at least 75 years old. Healio (free registration)/Ophthalmology (10/13)
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Featured Press Releases
Government & Regulatory
Final FDA guidance distinguishes device recalls from market withdrawals
Guidance outlining requirements for differentiating medical device recalls from market withdrawals has been finalized by the FDA. Apparently taking industry feedback into account, the final guidance revises how the terms "correction" and "removal" are defined. Manufacturers also will no longer be required to report device corrections or removals to the FDA but rather must keep records of them for two years. Regulatory Focus (10/14)
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Tool for CT-based bone mineral density measurement gets FDA OK
The FDA has cleared MindwaysCT to market its computed tomography calibration system for use in measuring bone mineral density using quantitative CT scans. The tool can also be used for retrospective evaluation of previously captured CT images. (10/14)
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AdvaMed News
Premarket Approval (PMA) Submissions Workshop
Thursday, Oct. 23 – Friday, Oct. 24
Washington Marriott at Metro Center
Completing the MTLI set of interactive submissions workshops, senior industry experts and members of the CDRH device evaluation and bioresearch monitoring staffs will lead participants through the strategic considerations and practical steps of filing a PMA, illustrated with real-world case studies. Topics include strategy development and evidence requirements, productive meetings with the FDA, the mechanics of submission development, advisory panels, inspectional activity, conditions of approval studies, and the care and feeding of approved PMAs. Visit MTLI online for more information.
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