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China Jo-Jo Drugstores revenues increase 20.9% to $18.0 million

China Jo-Jo Drugstores, which operates retail pharmacies in the People's Republic of China, reported financial results for the third quarter and nine-month period of fiscal 2011 ended December 31, 2010.

15 Feb 2011

Nfocus Neuromedical's Luna AES receives CE Mark approval to treat brain aneurysms

Nfocus Neuromedical, Inc., an innovative medical device company with a focus on the next generation treatment for brain aneurysms, announced today that its Luna Aneurysm Embolization System received CE Mark for the treatment of patients with brain aneurysms.

15 Feb 2011

FDA provides less-burdensome path to market certain hardware, software used with medical devices

Today, the FDA announced a final rule that provides a less-burdensome path to market for certain hardware and software products used with medical devices. The rule classifies these products, known as Medical Device Data Systems or MDDS, as Class I or low-risk devices, making them exempt from premarket review but still subject to quality standards.

15 Feb 2011

Rapid approvals for medical devices by FDA leads to increased recalls: Study

According to a latest study many medical devices recalled in recent years by the Food and Drug Administration (FDA) because they posed a high risk to patients were not rigorously studied before being approved for patient use. The study, appearing on the web site of The Archives of Internal Medicine, said that most medical devices that were the subject of high-risk recalls from 2005 to 2009 had been cleared through a regulatory pathway with little testing. This included external heart defibrillators, hospital infusion pumps and mechanical ventilators.

14 Feb 2011

bioMD makes offer for Allied Medical

bioMD Limited (ASX: BOD), a company with assets in regenerative tissue engineering technologies today announced that it has made an offer to buy all of the shares in Allied Medical Limited (Allied), a public unlisted company that specialises in the sales, distribution and commercialisation of medical technologies.

14 Feb 2011

BioTime to merge Glycosan with OrthoCyte

BioTime, Inc., a biotechnology company that develops and markets products in the field of stem cells and regenerative medicine, today announced it has signed a definitive agreement to merge Utah-based Glycosan BioSystems, Inc. (Glycosan) with BioTime's wholly-owned subsidiary, OrthoCyte Corporation. The acquisition is expected to close by March 18, 2011.

14 Feb 2011

Best Practices publishes new report on 'Innovations in Patient-Focused Initiatives'

For the biopharmaceutical industry, the changing healthcare marketplace has increased the importance - and difficulty - of interacting with patients to improve outcomes. New technologies and access restrictions have created both opportunities and challenges for approaching and engaging patient populations to improve disease control.

14 Feb 2011

Kyocera and JMM open new Orthopedic Design Center in the U.S.

Kyocera Industrial Ceramics Corp., Orthopedic Division, today unveiled its new Orthopedic Design Center in Somerset, N.J., formed in collaboration with Japan Medical Materials Corporation (JMM) - a Kyocera Group company.

14 Feb 2011

SpineSmith to rollout VisuALIF stand alone device for intervertebral body fusion of lumbar spine

SpineSmith, a Texas-based medical device company, today announces the company will begin the national rollout in March of the VisuALIF, following a successful Alpha launch.

14 Feb 2011

Cappella Medical presents new clinical data on Sideguard coronary sidebranch system at International JIM 2011

Cappella Medical Devices presented new clinical data on its unique Sideguard® coronary sidebranch system today at the International JIM 2011 in Rome, Italy.

11 Feb 2011

TMJ Medical receives FDA postmarket surveillance study order

TMJ Medical acknowledged Tuesday receiving a postmarket surveillance study order from the U.S. Food and Drug Administration. TMJ Medical is one of three medical device manufacturers approved to market temporomandibular joint (TMJ) implants in the United States. Each manufacturer received the same FDA order.

10 Feb 2011

CHI commends FDA's recognition of more efficient regulatory pathway for innovative medical devices

"CHI commends the FDA for its recognition of the need for a more efficient regulatory pathway for innovative medical devices that have the potential to improve lives," said CHI President and CEO David L. Gollaher, Ph.D. "It is essential that the FDA maintains focus on initiatives that strengthen the medical device review process, bringing greater clarity and consistency, while ensuring the U.S. maintains its competitive edge."

10 Feb 2011

Georgia Tech, Emory University startup receives $5.1M investment to develop novel cardiac surgery system

A Georgia Tech and Emory University medical device startup that has developed a system to simplify and standardize the technique for opening and closing the beating heart during cardiac surgery has received a $5.1 million investment.

10 Feb 2011

ALQAEM to release online blood glucose monitor in the M.E.N.A. regions

The Health Care Division of ALQAEM International FZE, the exclusive master distributor for the M.E.N.A. region of the UFIT noninvasive medical device created by Biosign Technologies Inc. of Canada, is pleased to announce that it has placed orders for delivery this quarter and will begin a limited release in March to those M.E.N.A. regions that recognize the CE Mark for medical device registration.

10 Feb 2011

FDA proposes plan to speed medical device reviews

The approach, which would focus on first-of-a-kind devices with the potential to make a significant difference for patients, could cut in half the current amount of time spent reviewing most new devices.

10 Feb 2011

PBNC technology may help detect cardiac disease, reduce diagnostic costs

Heart disease is a silent killer, but new microchip technology from Rice University is expected to advance the art of diagnosis.

9 Feb 2011

Minnetronix introduces new Cognita remote medical device monitoring and intelligence system

Minnetronix, a provider of award-winning product design, development and manufacturing services to the medical device and life science marketplaces, is pleased to announce the introduction of its latest product offering: the Minnetronix® Cognita™ System. The system will be debuted at the Medical Design & Manufacturing West Expo on February 8-10, in Anaheim, California.

9 Feb 2011

FDA proposes new Innovation Pathway program for pioneering medical devices

Today the U.S. Food and Drug Administration proposed the Innovation Pathway, a priority review program for new, breakthrough medical devices and announced the first submission: a brain-controlled, upper-extremity prosthetic that will serve as a pilot for the program. The FDA also announced plans to seek further public comment before the Pathway can be used more broadly.

9 Feb 2011

Revo pacemaker receives FDA approval for use during certain MRI exams

The U.S. Food and Drug Administration today approved the first heart pacemaker designed to be used safely during certain magnetic resonance imaging (MRI) exams.

9 Feb 2011

MRI Medical announces name change to Xeridiem Medical Devices

MRI Medical Inc. is changing its name to Xeridiem Medical Devices, Inc. as part of its corporate development plan.

9 Feb 2011

Medical Devices News and Research

China Jo-Jo Drugstores revenues increase 20.9% to $18.0 million

Nfocus Neuromedical's Luna AES receives CE Mark approval to treat brain aneurysms

FDA provides less-burdensome path to market certain hardware, software used with medical devices

Rapid approvals for medical devices by FDA leads to increased recalls: Study

bioMD makes offer for Allied Medical

BioTime to merge Glycosan with OrthoCyte

Best Practices publishes new report on 'Innovations in Patient-Focused Initiatives'

Kyocera and JMM open new Orthopedic Design Center in the U.S.

SpineSmith to rollout VisuALIF stand alone device for intervertebral body fusion of lumbar spine

Cappella Medical presents new clinical data on Sideguard coronary sidebranch system at International JIM 2011

TMJ Medical receives FDA postmarket surveillance study order

CHI commends FDA's recognition of more efficient regulatory pathway for innovative medical devices

Georgia Tech, Emory University startup receives $5.1M investment to develop novel cardiac surgery system

ALQAEM to release online blood glucose monitor in the M.E.N.A. regions

FDA proposes plan to speed medical device reviews

PBNC technology may help detect cardiac disease, reduce diagnostic costs

Minnetronix introduces new Cognita remote medical device monitoring and intelligence system

FDA proposes new Innovation Pathway program for pioneering medical devices

Revo pacemaker receives FDA approval for use during certain MRI exams

MRI Medical announces name change to Xeridiem Medical Devices

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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