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Synapse Biomedical, IFR to commercialize implantable systems that restore muscle function in paralyzed patients

Case Western Reserve University's Institute for Functional Restoration (IFR) and Synapse Biomedical Inc. have entered a partnership to commercialize fully implantable systems that restore muscle function in paralyzed patients.

16 Oct 2015

2015 Frost & Sullivan Asia Pacific CRO Company of the Year award goes to Quintiles

Quintiles has clinched the 2015 Frost & Sullivan Asia Pacific Contract Research Organization (CRO) Company of the Year award. Frost & Sullivan selected Quintiles based on its in-depth evaluation of CRO companies' performance in the current Asia Pacific market landscape and its emerging trends.

16 Oct 2015

Big data and analytics expected to play major role in Singapore’s healthcare market

Continuous data collection for chronic illness management is crucial to deliver personalized care for patients. In the era of globalization, patients still do not have the right tools to collect and share their physiological information on a frequent, real time basis.

16 Oct 2015

Nanovis announces availability of new FortiCore interbody fusion devices

Nanovis, a life sciences company committed to developing scientifically advanced regenerative platforms for implantable medical devices, today announced the availability of the FortiCore wedge shaped lordotic cervical cage and a transforaminal lumbar interbody fusion (TLIF) device with increased scaffolding.

15 Oct 2015

Slater endoscopy launches ENSIZOR® endoscopic scissors for bariatric surgery market

Slater Endoscopy, LLC, a medical device company that develops and manufactures minimally invasive flexible endoscopic devices, announced today the launch of its ENSIZOR® Endoscopic Scissors with Patented Edge Flex™ Technology to meet the needs of the growing endoscopic surgery market.

15 Oct 2015

Avita Medical sends devices and personnel to help treat mass burn victims in Taiwan

Avita Medical Ltd., a regenerative medicine company specializing in the treatment of wounds and skin defects, today announced that doctors in Taiwan have reported positive results from using ReCell® to treat burn victims of June’s waterpark disaster, with medics saying they have seen superior wound closure and better outcomes.

15 Oct 2015

LEADERS FREE clinical trial demonstrates superior safety, efficacy for BioFreedom compared with bare-metal stent

Biosensors International Group, Ltd., a developer, manufacturer and marketer of innovative medical devices, announced today that the LEADERS FREE clinical trial demonstrated superior safety and efficacy for BioFreedom compared with a bare-metal stent (BMS).

15 Oct 2015

Intuitive Surgical and Trumpf Medical team up to address hospitals’ need for operating room integration

Intuitive Surgical and Trumpf Medical are now offering Integrated Table Motion for the da Vinci® Xi® Surgical System in Europe. This first-of-its-kind product includes the latest Intuitive Surgical robotic-assisted surgical system and Trumpf Medical’s advanced operating table, the TruSystem® 7000dV. The surgical system and table have been seamlessly integrated to allow surgeons and anesthesiologists – for the first time – to make a comprehensive range of table adjustments easily and efficiently during da Vinci Surgery.

15 Oct 2015

ADMT announces filing of FDA 510(k) application for Angiodroid The CO2 Injector for Angiography

ADM Tronics Unlimited, Inc. has announced that a Premarket Notification 510(k) application has been filed with the US Food and Drug Administration for Angiodroid The CO2 Injector for Angiography (the "Angiodroid Injector") by Angiodroid America, Inc., a subsidiary of Angiodroid, Srl, in affiliation with Triotech Ventures and ADMT, as previously announced.

15 Oct 2015

Palm Beach Vapors unveils safe, fully customizable vaping technology for tobacco users

Millions of smokers worldwide have used vaping to help finally break free from the shackles of tobacco. An April 2015 study released by a team of researchers at Kings College London showed electronic cigarettes to be up to 95 percent less harmful than traditional cigarette smoking.

13 Oct 2015

Harris Health System to help HHS improve critical cyber infrastructure of healthcare sector

Harris Health System is the only healthcare system in the nation awarded a $150,000 grant to help the U.S. Department of Health and Human Services (HHS) develop and improve ways to share cybersecurity threat information and protect the critical cyber infrastructure of the nation's public and private healthcare sector.

13 Oct 2015

Gamma Medica secures CE Mark approval to distribute LumaGEM Molecular Breast Imaging system within EEA

Gamma Medica, Inc., a breast imaging medical device company, today announced the CE Mark approval allowing for the sale and distribution of the LumaGEM® Molecular Breast Imaging (MBI) system within the European Economic Area (EEA). Gamma Medica is finalizing distribution partners in strategic markets across the EEA.

12 Oct 2015

FDA orders three duodenoscope manufacturers in the U.S. to conduct postmarket surveillance studies

The U.S. Food and Drug Administration today ordered the three manufacturers of duodenoscopes marketed in the U.S. to conduct postmarket surveillance studies to better understand how the devices are reprocessed in real-world settings.

12 Oct 2015

Federal judge grants permanent injunction against South Dakota medical laser manufacturer

A federal judge in the U.S. District Court for the District of South Dakota yesterday granted the U.S. Food and Drug Administration a permanent injunction against 2035 Inc. and Robert "Larry" Lytle, doing business as QLasers PMA and 2035 PMA.

12 Oct 2015

FDA awards research grants to boost product development for patients with rare diseases

The U.S. Food and Drug Administration today announced it has awarded 18 new research grants totaling more than $19 million to boost the development of products for patients with rare diseases, which affect the lives of nearly 30 million Americans.

11 Oct 2015

FDA allows marketing of new EarLens Contact Hearing Device

The U.S. Food and Drug Administration today allowed marketing of a new hearing aid that uses a laser diode and direct vibration of the eardrum to amplify sound. The combination of laser light pulses and a custom-fit device component that comes in direct contact with the eardrum is designed to use the patient's own eardrum as a speaker and enables amplification over a wider range of frequencies for some hearing impaired persons.

9 Oct 2015

FDA approves expanded indication for Optune device for brain cancer patients

The U.S. Food and Drug Administration today approved an expanded indication for the Optune device to treat patients with newly-diagnosed glioblastoma multiforme (GBM), an aggressive form of brain cancer.

9 Oct 2015

Avita Medical gains two CE marks to complete skin healing portfolio

Avita Medical Ltd. (ASX: AVH), (OTCQX: AVMXY), a medical device company specializing in the treatment of wounds and skin defects, today announced it has received CE Mark authorization to market in Europe that will allow it to define and target its autologous cell suspension technology for particular clinical market segments.

9 Oct 2015

Wake Forest Baptist Medical Center announces creation of Technology Development Program

Wake Forest Baptist Medical Center today announced the creation of a Technology Development Program, a $15 million program to develop the ideas, discoveries and inventions of the faculty and staff of the Medical Center into life science technologies having the potential to benefit patients in the community and worldwide.

8 Oct 2015

Primasil innovation helps improve Paxman™ cooling cap

Collaboration between Primasil Silicones and its academic partner University of Huddersfield has enabled Paxman™ to bring relief to cancer patients undergoing chemotherapy by further reducing the risk of hair-loss during treatment.

From Paxman 7 Oct 2015

Medical Devices News and Research

Synapse Biomedical, IFR to commercialize implantable systems that restore muscle function in paralyzed patients

2015 Frost & Sullivan Asia Pacific CRO Company of the Year award goes to Quintiles

Big data and analytics expected to play major role in Singapore’s healthcare market

Nanovis announces availability of new FortiCore interbody fusion devices

Slater endoscopy launches ENSIZOR® endoscopic scissors for bariatric surgery market

Avita Medical sends devices and personnel to help treat mass burn victims in Taiwan

LEADERS FREE clinical trial demonstrates superior safety, efficacy for BioFreedom compared with bare-metal stent

Intuitive Surgical and Trumpf Medical team up to address hospitals’ need for operating room integration

ADMT announces filing of FDA 510(k) application for Angiodroid The CO2 Injector for Angiography

Palm Beach Vapors unveils safe, fully customizable vaping technology for tobacco users

Harris Health System to help HHS improve critical cyber infrastructure of healthcare sector

Gamma Medica secures CE Mark approval to distribute LumaGEM Molecular Breast Imaging system within EEA

FDA orders three duodenoscope manufacturers in the U.S. to conduct postmarket surveillance studies

Federal judge grants permanent injunction against South Dakota medical laser manufacturer

FDA awards research grants to boost product development for patients with rare diseases

FDA allows marketing of new EarLens Contact Hearing Device

FDA approves expanded indication for Optune device for brain cancer patients

Avita Medical gains two CE marks to complete skin healing portfolio

Wake Forest Baptist Medical Center announces creation of Technology Development Program

Primasil innovation helps improve Paxman™ cooling cap

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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