Top Story

• Delphinus pursues FDA OK for breast cancer device
  Delphinus Medical Technologies has submitted an application with the FDA for its SoftVue system, a 3D imaging device that could provide doctors with a safer and more precise alternative to mammograms in diagnosing breast cancer. CEO William Greenway said he hopes the company will get an FDA OK to begin marketing the device during the first half of 2013. Detroit Free Press (1/6)     

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Business & Market Trends

• Lifecodes to become part of Immucor
  Hologic has entered a deal to sell its subsidiary Lifecodes to Immucor for $85 million. Lifecodes is a provider of molecular and antibody-based assays for businesses specializing in transplant diagnostics, specialty coagulation and transfusion medicine. The deal is expected to be finalized in the second fiscal quarter. AuntMinnie.com (free registration) (1/4)     

• Ceterix Orthopaedics obtains $19.5M in funding round
  A round of financing from five investors has pulled in $19.5 million for Ceterix Orthopaedics, which hopes to obtain an additional $1.10 million. The Menlo Park, Calif.-based startup is the maker of a suturing device that helps doctors stitch challenging anatomical areas while avoiding surrounding tissue, cartilage or nerves. MedCityNews.com (1/5)     

• Fla. maker of nonmelanoma skin cancer device gets $2.4M boost
  Sensus Healthcare has secured $2.4 million in a round of financing from 19 backers. The Boca Raton, Fla.-based startup markets the SRT-100 system, which administers low-energy, targeted radiation therapy in a noninvasive manner to treat patients with nonmelanoma skin cancers. MedCityNews.com (1/4)     

• SeraCare Life Sciences moves to renew focus on IVD
  SeraCare Life Sciences has divested its biorepository assets to Precision Health Holdings, restructured its business and appointed new leaders. The changes, which come less than a year after SeraCare was purchased by a private equity group based in Chicago, are intended to re-establish the company's focus on in vitro diagnostic products. American City Business Journals/Boston/BioFlash blog (1/4)     

International Developments

• EU approves NeoChord's device for mitral valve repair
  European regulators have granted NeoChord CE mark approval to market the DS1000 Mitral Valve Repair device. The technology is designed to treat patients with mitral valve prolapse using an off-pump, transapical procedure. MassDevice.com (Boston) (1/4)     

• New medical device vigilance guidelines take effect in Egypt
  The Egyptian Drug Authority has finalized guidelines governing its medical device vigilance program, which details responsibilities for the agency's Medical Device Safety Department, device users and manufacturers. The guidance took effect on Jan. 1 and includes changes to a draft version released in 2011, including a new section on in vitro diagnostics. Clinica (subscription required) (1/4)     

Science & Health

• Partnership aims to improve prenatal diagnostics
  Baylor College of Medicine will work with Chinese firm Berry Genomics to enhance the way prenatal genetic testing is performed. The partnership will allow BCM to combine its gene-chip microarray tools, which are used to analyze chromosome structure, with Berry Genomics' systems for assessing fetal DNA derived from maternal plasma. GenomeWeb Daily News (free registration) (1/4)     

Emerging Technologies

• Soft Tissue's device to repair rotator cuff wins FDA nod
  Soft Tissue Regeneration has been cleared by the FDA to market a biodegradable scaffold for patients in need of rotator cuff repair and soft tissue augmentation. The STR Graft, set to be commercially available in 2014, is intended to reduce pain, minimize surgical failure and expedite patient recovery time. Healio (1/4)     

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Hot Topics

Top five news stories selected by AdvaMed SmartBrief readers in the past week.

• 3 things medical device firms should consider this year (MassDevice.com (Boston))

• Becton wraps up buyout of Safety Syringes (MassDevice.com (Boston))

• FDA approves breast cancer device from Dune Medical (American City Business Journals)

• Abbott's heart stent gains FDA approval (Reuters)

• DJO unit acquires maker of waterproof cast technology (Minneapolis/St. Paul Business Journal)

• Results based on number of times each story was clicked by readers.

Government & Regulatory

• Minn. group aims to reverse changes to 510(k) process
  The Minnesota Medical Device Alliance has filed a petition asking the FDA to discontinue certain definitions and administrative measures that the group says unlawfully alter the 510(k) clearance process. The petition cites practices adopted by the FDA since 2009, including wrongly applying "assurance case" and risk mitigation principles to 510(k) criteria. MedCityNews.com (1/4)     

AdvaMed News

• Investigational Device Exemption (IDE) Submissions Workshop
  Wednesday, Feb. 27
  Sheraton Crystal City, Arlington, Va.
  MTLI offers this one-day interactive workshop to lead attendees through the regulatory and practical guidelines governing when an IDE is required, how to compile an effective IDE application, the rules governing clinical studies and human subject protection, Institutional Review Boards, types of pre-IDE meetings and communications, early/expanded access, foreign studies and export, and reimbursement for investigational devices. Visit MTLI online for more information.     

• Join the AdvaMed-MTLI LinkedIn group!
  Build close relationships with member companies, both small and large, and receive an intimate understanding of the key issues affecting innovation, access and the bottom line. Interact in discussions that leverage the leadership and expertise of the medical technology industry. This social group is full of key stakeholders, influencers and industry thought leaders as well as regulatory and policy experts from the FDA and CMS. Aside from practical learning opportunities, this LinkedIn group provides the premier opportunity to network with key players from virtually every aspect of the industry. Link to the AdvaMed MTLI LinkedIn group page.     

Position Title Company Name Location Program Director, Regulatory Affairs Johnson & Johnson Fremont, CA Quality Systems Manager Roche Diagnostics Indianapolis, IN IP Litigation Counsel - 001980 Edwards Lifesciences Irvine, CA

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