Medical Devices News and Research

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SI-BONE's summit to develop clinical diagnostic process for SI Joint pathology identification

SI-BONE, Inc. a San Francisco Bay-area, medical device company, announced the first ever meeting of thought leading spine surgeons to review data and develop a clinical diagnostic process for identification of SI Joint pathology, a frequent cause of low back pain.

17 Sep 2009

Nuveta closes Series A seed financing round for in vitro fertilization research

Nuveta, Inc., a privately held medical device company and global leader in basic in vitro fertilization (IVF) research, announced today that it has closed a Series A seed financing round, solely funded by Vivo Ventures.

17 Sep 2009

FDA provides PMA approval for Spectrascience's WavSTAT technology enhancements

SpectraScience, Inc. (OTC Bulletin Board: SCIE), a San Diego based medical device company, today announced that its application for premarket approval (PMA) relating to key enhancements of its WavSTAT platform technology has been approved by the Food and Drug Administration. The Company can now begin commercial distribution of the enhanced WavSTAT technology.

17 Sep 2009

Americans for Tax Reform assesses the Baucus healthcare plan

Employer Mandate Tax. $400 per employee if health coverage is not offered. Note: this is a huge incentive to drop coverage, as $400 is much less than the average plan cost of $11,000 for families or $5000 for singles (Source: AHIP)

17 Sep 2009

Baucus unveils much-anticipated Senate Finance version of health overhaul legislation

Senate Finance Committee Chairman Max Baucus unveiled his version of a health overhaul bill, which has no public option and requires most people to have health insurance coverage.

16 Sep 2009

GENova in advanced negotiations to acquire patents from TheraGlass

GENova Biotherapeutics Inc. ("GENova") is pleased to announce that it is in advanced negotiations to acquire a number of patents from TheraGlass Ltd., a company that produces a ground-breaking regenerative bioactive material with exciting potential applications.

16 Sep 2009

Phase Forward advances its clinical trial and drug safety data management capabilities

For many large pharmaceutical and medical device firms, the task of capturing and managing volumes of clinical trial and drug safety data is often outsourced to experts like Phase Forward.

16 Sep 2009

Global medical device manufacturer procures Sono-Tek's MediCoat stent coating systems worth $400,000

Sono-Tek Corporation (OTC Bulletin Board: SOTK) announced today the sale of a series of its MediCoat DES 2000 stent coating systems to a leading global medical device manufacturer. The sale is Sono-Tek's largest ever sales transaction to the medical device industry, valued at approximately $400,000.

16 Sep 2009

EVEREST clinical trial results to be presented at the upcoming TCT Conference

The upcoming Transcatheter Cardiovascular Therapeutics (TCT) Conference, to take place in San Francisco from September 21-25, will serve as a backdrop for the presentation of EVEREST registry clinical results of the MitraClip(R) therapy for patients with mitral regurgitation (MR).

16 Sep 2009

Device makers, late to the table, object to new fees in health bills

"The $100 billion medical-device industry is scrambling to reverse billions of dollars in fees proposed by the Senate Finance Committee, but it faces trouble because its reluctance to offer concessions alienated some lawmakers," the Wall Street Journal reports.

16 Sep 2009

Laser technology lowers manufacturing cost of artificial joints and arterial stents

Researchers are developing technologies that use lasers to create arterial stents and longer-lasting medical implants that could be manufactured 10 times faster and also less expensively than is now possible.

16 Sep 2009

Baucus works to iron out Medicaid, abortion and costs in health reform bill

Sen. Max Baucus is addressing the final questions in his Senate Finance Committee health care reform bill and plans to offer it Wednesday, opening the way for a committee vote next week and a floor vote the week after.

16 Sep 2009

Congressional aides for health care have industry ties

"Some of the most influential aides in the closed-door Senate Finance Committee negotiations over health care reform have ties to interests that would be directly affected by the legislation," Politico reports.

16 Sep 2009

Council briefing series to examine role of public policy in promoting medical innovation

The Council for American Medical Innovation will host a breakfast briefing on Capitol Hill titled "Translational Research - From Bench to Bedside." Health policy experts will explore important changes needed to improve the process of development and approval for safe and effective drugs, biologics, medical devices and diagnostics.

15 Sep 2009

Biocryst signs agreement with three partners to represent its anti-viral peramivir outside U.S.

BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that it has signed binding letters of intent with three partners who will exclusively represent BioCryst and its anti-viral peramivir for influenza stockpiling opportunities, as well as for marketing and distribution of peramivir for seasonal influenza upon local regulatory approval, within their territories outside the U.S.

15 Sep 2009

New hydrogel mats extends anti-infection protection

Treatment of hospital-related infections in the U.S. costs up to $11 billion a year and about half of those infections are related to medical devices implanted in patients. Until now, efforts to control drug-resistant biofilms on such devices have been largely unsuccessful.

15 Sep 2009

RAPS honors award recipients for contributions to healthcare product regulatory profession

The Regulatory Affairs Professionals Society (RAPS) today honored the recipients of its prestigious awards for outstanding contributions to the healthcare product regulatory profession. RAPS' Leonard Stauffer Award for mentoring and furthering regulatory professional education was given to independent consultant Nanci Dexter.

15 Sep 2009

Alnylam and Medtronic announce pre-clinical research findings from their Huntington’s disease program

Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, and Medtronic, Inc. (NYSE: MDT), the world’s leading developer of medical devices, announced today the presentation of new pre-clinical research findings from their Huntington’s disease program at the 2009 World Congress on Huntington’s Disease held September 12-15, 2009 in Vancouver, British Columbia.

15 Sep 2009

Significant uptake of medical imaging equipment in Ghana

Ghana's healthcare industry is experiencing growth across a range of sectors. However, the drive towards improved diagnostic capability has led to high demand for medical imaging devices.

15 Sep 2009

Misonix receives donation from anonoymous patient to buy SonicOne ultrasonic wound care system

Misonix, Inc. (Nasdaq: MSON), a developer of minimally invasive ultrasonic medical device technology, which in Europe is used for the ablation of tumors and worldwide for other acute health conditions, has announced that a patient, who wishes to remain anonymous, donated the majority of the funds necessary for Christus St. Vincent Medical Center, Santa Fe, NM, to purchase a SonicOne(R) Ultrasonic Wound Cleansing and Debridement System. The System was shipped and installed during the second half of August 2009.

15 Sep 2009

Medical Devices News and Research

SI-BONE's summit to develop clinical diagnostic process for SI Joint pathology identification

Nuveta closes Series A seed financing round for in vitro fertilization research

FDA provides PMA approval for Spectrascience's WavSTAT technology enhancements

Americans for Tax Reform assesses the Baucus healthcare plan

Baucus unveils much-anticipated Senate Finance version of health overhaul legislation

GENova in advanced negotiations to acquire patents from TheraGlass

Phase Forward advances its clinical trial and drug safety data management capabilities

Global medical device manufacturer procures Sono-Tek's MediCoat stent coating systems worth $400,000

EVEREST clinical trial results to be presented at the upcoming TCT Conference

Device makers, late to the table, object to new fees in health bills

Laser technology lowers manufacturing cost of artificial joints and arterial stents

Baucus works to iron out Medicaid, abortion and costs in health reform bill

Congressional aides for health care have industry ties

Council briefing series to examine role of public policy in promoting medical innovation

Biocryst signs agreement with three partners to represent its anti-viral peramivir outside U.S.

New hydrogel mats extends anti-infection protection

RAPS honors award recipients for contributions to healthcare product regulatory profession

Alnylam and Medtronic announce pre-clinical research findings from their Huntington’s disease program

Significant uptake of medical imaging equipment in Ghana

Misonix receives donation from anonoymous patient to buy SonicOne ultrasonic wound care system

Industry Focus eBook - Medical Devices (3rd Edition) eBook

Evaluating new approaches for rare disease genomics

Expanding access to NMR with the Fourier 80 Duo

Advancing Intracellular Delivery with LumiPore®

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