Boston Scientific plans 3-year restructuring program | Funding round pulls in $29M for RenalytixAI | Mobidiag gets $4.52M boost through EU financing project
November 16, 2018
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AdvaMed bullish about device tax repeal in lame-duck session
A measure that would repeal the medical device tax could garner over 60 votes in the Senate during the lame-duck session, AdvaMed President and CEO Scott Whitaker said. "[O]ur focus is going to be laser-like on full repeal and full repeal only. If it doesn't get done this year, then we will reassess where we are and talk about an alternative approach," Whitaker said.
MassDevice (Boston) (11/15) 
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Could a pill eliminate the mammogram?
University of Michigan engineering researchers developed a pill that makes breast tumors glow under infrared light. Their method —demonstrated in mice—could distinguish aggressive tumors from benign, and potentially prevent unnecessary treatments. Learn how it works in Smithsonian.
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Business & Market Trends
Boston Scientific plans 3-year restructuring program
Boston Scientific is planning a restructuring program from 2019 to 2021 and to cut operating annual expenses by up to $150 million and improve performance. The company expects a relatively unchanged total headcount after completion of the program.
The Business Journals (tiered subscription model)/Boston (11/16),  Seeking Alpha (11/15) 
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Funding round pulls in $29M for RenalytixAI
A round of financing has brought in $29 million for RenalytixAI, a UK-based company that makes artificial intelligence-enabled diagnostics for kidney disease. The proceeds will be used to develop and commercialize two product categories for early kidney disease detection and kidney transplant rejection management.
FinSMEs (11/15) 
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Mobidiag gets $4.52M boost through EU financing project
The European Investment Bank has provided the final $4.52 million tranche of a three-year project, valued at approximately $17 million, to Finland-based molecular diagnostics firm Mobidiag. The financing, provided under the InnovFin - EU Finance for innovators, has already supported the finalization, launch and commercialization of the company's Novodiag molecular diagnostic system and has allowed the company to develop the Novodiag Bacterial GE+ and Novodiag C. difficile assays for detecting gastrointestinal infections.
GenomeWeb Daily News (free registration) (11/15) 
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Valeritas looks to offer more shares in public offering
A preliminary prospectus has been filed by Valeritas for a public offering of around 44.1 million shares of common stock and Series A and B share purchase warrants, up from about 27.8 million shares and warrants filed for previously.
Seeking Alpha (11/15) 
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Helius Medical Technologies announces pricing of public offering
A public offering of approximately 2.1 million Class A common shares has been priced by Helius Medical Technologies at $8.25 each.
Seeking Alpha (11/15) 
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Science & Health
Pulmonx scores reimbursement win for Zephyr endobronchial valve
Aetna has issued a positive coverage policy for Pulmonx's Zephyr endobronchial valve system, naming it as an approved bronchoscopic option for lung volume reduction. The device is designed for treating severe emphysema and chronic obstructive pulmonary disorder.
MassDevice (Boston) (11/15) 
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Emerging Technologies
NuVasive debuts implant for lateral ALIF
NuVasive has launched the Brigade Lateral implant for lateral anterior lumbar interbody fusion spine surgery. The implant provides a low-profile and reproducible insertion process to improve surgical workflow in the operating room.
Becker's Spine Review (11/15) 
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Government & Regulatory
FDA, EU clear Abbott's DRG Invisible Trial System
The FDA has granted Abbott clearance to market its DRG Invisible Trial System, which is designed to provide trial treatment with the company's dorsal root ganglion stimulation therapy to patients with complex chronic pain conditions. The system has also received CE mark approval from European regulators.
MassDevice (Boston) (11/15) 
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Terumo's blood parameter monitoring system wins FDA clearance
The FDA has given Terumo Cardiovascular Group 510(k) clearance for its CDI Blood Parameter Monitoring System 550, a next-generation system that measures 12 critical blood parameters. The system comes with an improved probe design, an advanced optical fluorescence technology and a high-visibility LCD screen.
Compelo/Medical Devices (11/15) 
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AdvaMed Events and Education
Recalls From A To Z: Regulations, Decisions, Procedures, And Best Practices Workshop
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During this workshop, you'll establish a clear understanding how the regulatory affairs function is pivotal to every recall and every team decision. After partaking in detailed discussions and strategies of communicating with the FDA, you'll learn to understand the points to consider when writing public recall notifications. At this interactive workshop, you will have access to network with industry leaders and FDA experts. Learn more.
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