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Realton closes Series B financing

Realton Corporation, a pioneer in developing diode-pumped laser systems initially targeted to treat enlarged prostate, today announced the closing of its Series B financing co-led by OrbiMed Advisors and China Healthcare Partnership. Existing investor CSV Capital Partners will also participate in the financing. The financing will be used primarily to enhance Realton's marketing and distribution networks, expand its manufacturing capabilities and pursue new technology development.

29 Apr 2010

NIDCR awards Selenium $912,943 grant for development of antimicrobial dental devices and water lines

The National Institute of Dental and Craniofacial Research (NIDCR), one of the National Institutes of Health (NIH), has issued a two-year $912,943 grant to biopharmaceutical company Selenium, Ltd. to support the development of antimicrobial dental devices and water lines. In the two-part grant the NIH has approved $492,972 for year one and $419,971 for year two dependent on achieving year one objectives.

29 Apr 2010

ECRI Institute's recommendations for controlling CT radiation dose

The benefits of computed tomography (CT) have increased greatly over the past decade. Now twice as powerful, it offers dynamic images of anatomy, including the beating heart. Future advancements promise to deliver even more clinical benefits. However, CT has always had a downside: it can deliver high radiation doses to patients, putting them at increased risk of developing cancer.

29 Apr 2010

USPTO issues new patent to Applied Spine Technologies

Applied Spine Technologies, Inc. www.appliedspine.com, a medical device company focused on motion preservation of the lumbar spine, has been awarded a new patent titled "Spinal Stabilization Device with Weld Cap".

29 Apr 2010

FDA grants Fenwal 510(k) clearance for Amicus separator with DXT

Fenwal, Inc., a global medical technology company focused on improving blood collection, separation, safety and availability, announced today the U.S. Food and Drug Administration has granted Fenwal 510(k) clearance for its Amicus® separator with new wireless data-export capabilities.

29 Apr 2010

Maryland startup Rhemisphere signs agreement with UMB for right to commercialize Blink system

Maryland startup Rhemisphere, LLC has licensed a unique, "all-in-one" patient monitoring system invented by clinical researchers at the University of Maryland, Baltimore.

28 Apr 2010

Boston-Power announces lithium-ion battery technology for medical device and equipment market

Boston-Power®, Inc., the rapidly growing provider of next-generation lithium-ion batteries, is responding to strong customer and partner demand by bringing its industry-leading lithium-ion battery technology to the multi-billion dollar global medical device and equipment market. Boston-Power's lithium-ion battery cells deliver unmatched levels of long life, fast charge and safety to a market that demands the most stringent standards of battery reliability to ensure that patients receive the highest quality of care.

28 Apr 2010

Phase II clinical trial to test safety and efficacy of transplanted encapsulated islets

The Juvenile Diabetes Research Foundation announced today that it is partnering with Living Cell Technologies, a New Zealand-based biotechnology company focused on developing cell based therapeutics, in a Phase II clinical trial to study the safety and effectiveness of transplanting encapsulated insulin-producing cells from pigs as a treatment for type 1 diabetes with significant hypoglycemia unawareness.

28 Apr 2010

SI-BONE to present iFuse MIS procedure at WCMISST 2010

SI-BONE, Inc., a medical device company that is pioneering the use of a minimally invasive surgical device to treat the sacroiliac joint today announced that iFuse initial post-market clinical experience will be presented at upcoming 2010 minimally invasive spine surgery meetings.

28 Apr 2010

Alair Bronchial Thermoplasty System receives FDA approval to treat asthma in adults

The U.S. Food and Drug Administration today approved the first medical device that uses radiofrequency energy to treat severe and persistent asthma in certain adults.

28 Apr 2010

TYRX receives FDA marketing clearance for AIGISRx ST antibacterial patch for soft tissue repair

TYRX, Inc. announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market AIGISRx® ST, its antibacterial product for the surgical repair of damaged or ruptured soft tissue.

28 Apr 2010

ICON reports net revenues of $219 million for first-quarter 2010

ICON, a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, today reported its financial results for the first quarter ended March 31, 2010.

27 Apr 2010

Concord Medical signs definitive agreement to acquire 100% equity interest in Tianjin Kangmeng Radiology

Concord Medical Services Holdings Limited, operator of the largest network of radiotherapy and diagnostic imaging centers in China, today announced that its wholly-owned subsidiary, Shenzhen Aohua Medical Device Leasing Co., Ltd., has entered into a definitive agreement to acquire 100% of the equity interest in Tianjin Kangmeng Radiology Equipment Management Co., Ltd., a company that manages four radiotherapy and diagnostic imaging centers in Hebei province.

27 Apr 2010

KCI applauds FDA for launching medical device home use initiative

KCI applauds the FDA for launching this important initiative to ensure that complex medical devices are used safely in the home by caregivers and patients. We have made it our priority and unwavering responsibility to help caregivers and patients understand how to use our advanced treatments safely. This includes offering a robust education and training program, employing highly trained clinical support staff and providing easy-to-read, patient-specific labeling.

27 Apr 2010

Chubb WORLDcert system simplifies process for obtaining clinical trial liability insurance documentation

A new online system from the Chubb Group of Insurance Companies will help life sciences companies deliver life-saving products to market faster by simplifying the process for obtaining clinical trial liability insurance documentation. The new system, Chubb WORLDcert, allows drug and medical device developers to quickly secure required insurance documentation for clinical trials around the globe.

27 Apr 2010

LCT receives grant of $500,000 for Phase II clinical trial of DIABECELL in New Zealand

Living Cell Technologies Limited, a global company pioneering the development of a cell implant to treat diabetes, has received a grant of US$500,000 for its on-going Phase II clinical trial of DIABECELL in New Zealand from the Juvenile Diabetes Research Foundation International, a world leader in setting the agenda for diabetes research and the largest charitable funder and advocate for research in type 1 diabetes.

27 Apr 2010

ThermoGenesis extends reach of stem cell regenerative medicine market into Asia, Central and South America

ThermoGenesis Corp., a leading supplier of innovative products for processing and storing adult stem cells, announced today that it has signed two new distribution agreements that will further extend its global reach into Asia and Central and South America for its offerings in the bone marrow stem cell regenerative medicine market. The Company has now completed four new distribution agreements in the past 90 days, significantly enhancing its ability to market and sell its products throughout the world.

27 Apr 2010

New health law will require industry to disclose payments to physicians

Doctors who accept speaking fees, five-star meals and other compensation from pharmaceutical or medical device companies will soon see their names - and the value of the gifts they accept - revealed on the Web, under a new federal law that follows several states in drawing attention to such financial benefits" (Weintraub, 4/26).

27 Apr 2010

Costs, effects on business questioned as health overhaul analysis continues

The Associated Press: The biggest unanswered question in the health overhaul debate remains what the new law will mean for ordinary Americans. "Many experts believe the law falls short on taming costs, and that will force Congress to revisit health care in a few years.

27 Apr 2010

First Edition: April 26, 2010

Today's headlines reflect state-level health policy developments as well as forward-looking stories related to the cost of federal health reforms.

26 Apr 2010

Medical Devices News and Research

Realton closes Series B financing

NIDCR awards Selenium $912,943 grant for development of antimicrobial dental devices and water lines

ECRI Institute's recommendations for controlling CT radiation dose

USPTO issues new patent to Applied Spine Technologies

FDA grants Fenwal 510(k) clearance for Amicus separator with DXT

Maryland startup Rhemisphere signs agreement with UMB for right to commercialize Blink system

Boston-Power announces lithium-ion battery technology for medical device and equipment market

Phase II clinical trial to test safety and efficacy of transplanted encapsulated islets

SI-BONE to present iFuse MIS procedure at WCMISST 2010

Alair Bronchial Thermoplasty System receives FDA approval to treat asthma in adults

TYRX receives FDA marketing clearance for AIGISRx ST antibacterial patch for soft tissue repair

ICON reports net revenues of $219 million for first-quarter 2010

Concord Medical signs definitive agreement to acquire 100% equity interest in Tianjin Kangmeng Radiology

KCI applauds FDA for launching medical device home use initiative

Chubb WORLDcert system simplifies process for obtaining clinical trial liability insurance documentation

LCT receives grant of $500,000 for Phase II clinical trial of DIABECELL in New Zealand

ThermoGenesis extends reach of stem cell regenerative medicine market into Asia, Central and South America

New health law will require industry to disclose payments to physicians

Costs, effects on business questioned as health overhaul analysis continues

First Edition: April 26, 2010

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

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

Expanding access to NMR with the Fourier 80 Duo

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