Medical Device Daily State of the Industry 2011: Med-tech Market Trends, Strategies and Insight
Bioworld Online/AHC Media
November 1, 2011 SKU: CCAQ6748975
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The State of the Industry Report brings you the predominant news, the cutting-edge innovation, imperative regulation/legislation, financial undertakings, business development activities, and the aggregate market-bearing dynamics that have defined and shaped the current state of the global medical technology market this year.
We also dive into the regulatory changes and legal decisions that have been impacting our industry ... Healthcare Reform Act, the 510(k) regulatory process, the emergence and likely effect of Accountable Care Organizations, and pending judicial decisions that impact research, products and your business.
We bring you the analysis, the instant recall, and the business intelligence you need to help you move ahead and make truly knowledgeable evaluations of the industry and where it s heading.
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- About Medical Device Daily
- Introduction
- Med-tech innovation may be exiting U.S., other countries may fill the gap
- Where We’re Headed
- Clinic unveils highly anticipated Top
- DeParle plugs healthcare reform to skeptical crowd
- Health IT panel proves to be HIT with conference attendees
- Opportunities seen in ortho and neurostimulation spaces
- Paulsen slams policies that hold back medical technology
- Asian markets, especially China, draw interest from attendees
- Opportunities abound in cardio despite regulatory headwinds
- Goldman; still too many stray e-parts in typical hospital suite
- Kappos: end of fee diversion not the end of scrutiny of PTO
- Shared EHRs are blocked by incompatibility of med-tech
- Cosgrove: U.S. is currently ‘fattest country in the world’
- Executive/Legislation
- Stupak eyed a shutdown of DTC gene testing operations
- Baucus takes aim at Medtronic over canceled Novation contract
- Stanford v. Roche a warning to universities about contracts
- Senate eyes doc-owned device distributors, urges OIG review
- House passes patent bill; fees, prior user issues loom
- Grassley, Kohl argue for more FDA control of device recalls
- Supreme Court avails itself of another review of Prometheus
- Survey: lawsuit fears hinder adoption of new med-tech
- Court rules Bilski patent not eligible on narrow grounds
- Healthcare reform enrollment mandate ruled unconstitutional
- Regulatory
- Carriers may decide on FDG solid tumor follow-up scans
- CMS eyes MRI for pacemakers, ICDs; FDA still mum on Revo
- Design controls may be en route for lab-developed tests
- CMS proposes a two-year demo for Part B imaging DSS systems
- FDA cracking down on personalized knee systems
- CMS offers more class IV VAD coverage, none in class IIIb
- AdvaMed chimes in on class IIb while FDA ponders changes
- FDA rescinds the controversial Menaflex
- FDA publishes long-awaited
- FDA eyes reclassification of AEDs to class III/PMA
- FDA releases special controls for wound closures, NPWTs
- CMS proposes trial coverage of MRI with ICDs, pacemakers
- Advisory panel floats ‘class III lite’ category for AEDs
- Study says device recalls in U.S., EU, similar
- AMIC says overall Medicare imaging down
- Matrixx decision could prompt more data dumps in SEC filings
- Financings
- CEOs are bullish about going public and launching in Europe
- Funding gap is a continuing problem for start-up firms
- Boston Scientific gets $3B credit line to repay debt
- Deals
- $23.3B Novartis/Alcon deal paces an active list of med-tech transactions
- Interviews
- Chris Coburn: Cleveland Clinic’s magician turns innovation into products
- Chris Rivera: Washington Biotechnology & Biomedical Association president
- William Trainor: Mutual Capital Partners co-founder
- Manny Villafana: Med-tech entrepreneur extraordinaire
- Rick Randall: Chairman/CEO, Avantis Medical & veteran med-tech executive
- Biomaterials
- Tissue engineering, related technologies are focus at conference
- Guided stem cells may provide therapy for chronic HF patients
- Research shines spotlight on regenerative medicine
- TRT enlists ‘soft’ shock wave to help heal tissue
- CorMatrix ECM shows potential to reduce new onset post-op AF
- Kuros regains rights from Baxter for KUR candidates
- Cardiovascular
- Disruptive cardio technologies attracting investors’ attention
- Cardiothoracic surgeons learn of latest surgical innovations
- Device-based HF therapies linked to lower mortality risk
- CorMedix sees big opportunity with drug/device combination
- Analysts see HeartWare taking lead in LVAD market position
- St. Jude announces first implant of Portico valve
- Medtronic launches Contour
- Medtronic could face significant stumbling block in AFib market
- Medtronic gains FDA approval for Consulta and Syncra CRT-Ps
- TAVR matches surgery survival, but shows higher stroke rate
- Boston Sci receives approval for ION DES
- Covidien’s TurboHawk PAD excision system launched
- Diagnostics
- Diagnostics field faces legal and regulatory growing pains
- Reimbursement change may boost adoption of MTWA test
- Lantheus to focus on less invasive cardio-tests
- GE seeks better diagnosis of early stage colon cancer
- FDA clears first lab-quality tBili test available in NICU
- Chembio Diagnostics provides patients rapid HIV test results
- Advances in PSA testing may reduce unnecessary biopsies
- Gene testing of fluid specimens helps identify cancer origin
- Pathwork gains approval for its new Tissue of Origin test
- Roche wins FDA approval for Elecsys anti-HCV test
- Seegene develops Sepsis assay and TB diagnostics application
- Elekta’s Symmetry now gives
- SMI to use satellite spy technology to find cancer
- Monitoring diabetes an issue; there’s an app for that too
- Healthcare IT
- Heavy metal gives way to software in new products
- Europe scales up cross-border e-health and tele-monitoring
- Shared EHRs are blocked by incompatibility of med-tech
- France brings EHR online targeting
- U.S. News names the most connected hospitals in U.S.
- FDA’s mobile medical app draft may allow class III designation
- ‘Meaningful use’ of EHRs defined in two final rules
- New mobile app to help decipher medical tests
- GE snags meeting spotlight for several HIT announcements
- Imaging
- Agfa takes a step back in X-ray to advance with IT
- Merging MRI with PET Siemens challenged to prove clinical case
- Price war unofficially declared in Europe for digital X-ray
- Superior capabilities boost hybrid imaging, says report
- Draeger monitors to feature novel imaging modality
- VisualSonics developing new photoacoustics imaging tool
- Study supports VH IVUS over angiographic imaging
- Siemens crafts panel to focus on lowering CT scan radiation
- Path clearer for Hologic’s
- International
- Interventionalists embrace new hypertension therapy
- Tightening up on TAVI to extract stronger evidence
- Virtual FFR to disrupt
- Biomed meeting comes alive with tour of conference floor
- Vexing barriers for U.S. entry push Vexim to global markets
- MRI wins a reprieve from the European Commission
- Authors of BMJ article seek tighter UK device recall regs
- AMO prosthetic arm movement fueled by signals from the brain
- Seeing opportunity, OrbiMed sets up new fund in Israel
- Israel’s commitment to the biomed community strong
- Nanotech
- Abbott reports Xience nano approved in smaller vessels
- Micro-optimism detected among nano manufacturers
- Roche inks OEM pact with IT-IS for LightCycler Nano
- Shrink Nano, EV to design StemDisk cell platform
- Dynasil company wins $6.2M in DoE grants
- Microvisk Technologies raises £2.5 million in financings
- Neurology
- CAE vs. CAS debated by surgeons at ISC meeting
- Opportunities seen in ortho and neurostimulation spaces
- FDA grants IDE approval for Penumbra’s THERAPY trial
- FDA approves Covidien’s DuraSeal Exact spine sealant
- St. Jude ‘broadens’ clinical study with FDA approved expansion
- PFO/stroke connection remains perplexing medical conundrum
- Medtronic DBS system gets CE mark for epilepsy indication
- NeuroPace seeking PMA for neurostimulation system
- BrainStorm engages Mass. hospitals for ALS research
- Oncology
- Latest breast cancer research reveals potential paradigm shifts
- New clinical research validates Calypso’s Gating technology
- First five patients treated in TriVascular’s OVATION trial
- KRAS diagnostic test receives CE Mark
- MPC to use ITA’s eviti for oncology support
- BSD Medical’s technology receives boost from study
- Imaging’s future role in cancer therapy evaluated
- OncoSec, not your typical startup by a long shot
- HexaPOD offers greater accuracy in cancer treatment
- NICO gets CE mark for Myriad brain tumor removal device
- Everist hits the market with its colorectal cancer assay
- Ophthalmology
- NovaVision hopes to bring VRT technology to forefront
- Arizona engineer develops at-home glaucoma test
- RHP in opthalmology space with newly launched BVI
- Japanese contact lens maker Menicon acquires Lagado
- PixelOptics develops notable new alternative to bifocals
- Retina Implant eyeing U.S. clinical trial site
- VisionCare telescope implant approved by FDA for AMD
- Orthopedics
- AAOS attendees are cautiously optimistic on orthopedics sector
- Smaller orthopedic companies providing big spark for sector
- Carticept Medical receives FDA approval for NDS
- FDA clears Aquamantys bipolar sealer from Salient
- Sanuwave’s orthoPACE gets boost from new study
- Emerge sees a need for line of generic orthopedic devices
- LDR in bid to gain FDA approval for Mobi-C
- Medtronic launches new Kyphon Xpede Bone Cement
- DSM plays behind the scenes role in device development
- Analyst sees opportunity in ‘new age’ of orthopedics
- Surgical
- Single Port Surgery and the Robot: Who Pays?
- Updates in Gynecology: Robotic Trends & Clinical Trials
- New modality for monitoring lung set to challenge CT, TEE
- Maquet and Philips reveal ‘truly hybrid’ operating room
- Presenters tout big advances with lasers in cataract surgery
- Surgeon combines lasers and robots for procedures
- Several non-surgical attempts to address obesity epidemic fail
- New studies bolster safety and efficacy of Lap-Band
- Women’s Health
- New imaging modalities focus on breast cancer
- China to dominate low-end European ultrasound market
- Halt closer to fibroid indication with FDA OK of ablation system
- Guided Therapeutics seeks PMA to find cancer via light
- Group launches Vivere to tackle ART procedures
- Mammostrat helps quantify likelihood of breast cancer recurrence
- FDA approves first
- Few regret elective removal of healthy breast years later
- FDA approves HER2 gene assay status in breast cancer patients
- Index
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