Medical Devices News and Research

RSS

Biopharmaceutical companies still trying to find the best ways to measure effectiveness of CAPA processes

A well-defined CAPA system is essential for any biopharmaceutical company to drive quality improvements across the organization. Hence, it is imperative for biopharmaceutical organizations to measure the effectiveness of their CAPA processes to identify potential areas of improvement in their quality function.

25 Jul 2015

New benchmarking study reveals current corporate library services within biopharmaceutical industry

Corporate libraries and information centers are under increasing pressure in today's environment of shrinking business resources. To meet those pressures, libraries and information centers need to demonstrate their value to their organization. That means library leaders need to know whether their activities are cost effective and whether they are spending in the areas that have the greatest impact for their customers.

25 Jul 2015

TSO3 obtains purchase orders from the US for STERIZONE sterilization system

TSO3 Inc., an innovator in sterilization technology for medical devices in healthcare settings, today announced that the Company has received purchase orders for multiple devices from the US. The orders are the result of the collaborative relationship between Getinge Infection Control, its sales and service provider, and the Company.

24 Jul 2015

NeoGraft selects Verasoni Worldwide as marketing communications partner

NeoGraft is pleased to announce the selection of Verasoni Worldwide as integrated marketing communications partner. NeoGraft is a world leader in hair replacement technology serving physicians and patients in the United States and around the world. NeoGraft is the first Class One FDA Listed automated medical device for hair restoration.

23 Jul 2015

MediCollector to commercialize Wyss Institute's bedside data-acquisition software

The Wyss Institute for Biologically Inspired Engineering at Harvard University today announced that its bedside data-acquisition software will be commercialized by a recently formed startup company, MediCollector LLC. The announcement follows a worldwide license agreement between Harvard's Office of Technology Development and MediCollector.

23 Jul 2015

New, nontoxic surgical glue helps heal wounds without scar or inflammation

One of the most basic yet important surgical skills to keep a patient alive and intact may be closing wounds. It seems that doctors will now get the job done with more ease thanks to new, nontoxic surgical glue that instantly seals a bleeding wound and helps it heal without a scar or inflammation.

22 Jul 2015

Avita Medical’s unique regenerative technology offers hope for burn victims

Avita Medical Ltd., a medical device company specializing in the treatment of wounds and skin defects, today said a branch of the U.S. Military says the U.S. Department of Defense ‘wants to use’ the company’s ReCell technology, which it described as offering a possible ‘paradigm shift’ in skin injury treatment.

22 Jul 2015

Expanded use for IntelliCap with further CE Mark for aspiration of fluids

The small, pill-shaped IntelliCap wireless medical device is opening up research opportunities into the impact of the small intestine microbiota on health and disease. For the first time, scientists have been able to obtain and analyse samples of the small intestine’s microbiome in a non-invasive way.

21 Jul 2015

XIAFLEX approved in Japan for treatment of patients with Dupuytren's contracture

BioSpecifics Technologies Corp., a biopharmaceutical company developing first in class collagenase-based products, announced that Asahi Kasei Pharma Corporation has received approval for its regulatory application to the Japanese Pharmaceutical and Medical Device Agency (PMDA) for XIAFLEX (collagenase clostridium histolyticum) for the treatment of patients with Dupuytren's contracture in Japan.

20 Jul 2015

Melphalan granted FDA Orphan Drug Designation for treatment of cholangiocarcinoma

Delcath Systems, Inc., a specialty pharmaceutical and medical device company focused on oncology with an emphasis on the treatment of primary and metastatic liver cancers, announced today that the U.S. Food and Drug Administration Office of Orphan Products Development has granted Orphan Drug Designation for melphalan for the treatment of cholangiocarcinoma.

20 Jul 2015

Mindray Medical announces completion of Wuhan Dragonbio acquisition

Mindray Medical International Limited, a leading developer, manufacturer and marketer of medical devices worldwide, announced today that it completed the acquisition of the remaining stake in Wuhan Dragonbio Surgical Implant Co., Ltd. for a total cash consideration of RMB 435 million (approximately US$ 70.2 million) pursuant to the terms of the definitive agreement entered into on July 7, 2015.

From Mindray 17 Jul 2015

ForeverGreen Worldwide earns BSCG's anti-doping certification for PowerStrips

ForeverGreen Worldwide Corporation, a leading direct marketing company and provider of health-centered products, today announced the company has received an anti-doping certification from the Banned Substances Control Group for PowerStrips, indicating the product is free of banned substances.

14 Jul 2015

OphthaliX updates website to reflect proposed acquisition of Israel-based Improved Vision Systems

OphthaliX Inc., a clinical-stage company focused on developing products that treat and improve sight for people living with ophthalmic disorders, and a subsidiary of Can-Fite BioPharma Ltd., announced today it has launched an updated website, www.ophthaliX.com, to reflect its definitive agreement to acquire Israel-based Improved Vision Systems Ltd.

14 Jul 2015

Researchers develop new approach for better integrating medical devices with biological systems

Researchers have developed a new approach for better integrating medical devices with biological systems. The researchers, led by Bozhi Tian, assistant professor in chemistry at the University of Chicago, have developed the first skeleton-like silicon spicules ever prepared via chemical processes.

9 Jul 2015

Amedica receives FDA feedback on proposed wear testing femoral head protocols

Amedica Corporation, a company that develops and commercializes silicon nitride ceramics as a biomaterial platform, today announced that responses to the U.S. Food and Drug Administration inquiries regarding the Company’s cervical composite silicon nitride interbody device were submitted to the FDA on June 30, 2015.

8 Jul 2015

OBP Medical introduces CLEAR-TRAC family of disposable surgical retractors

OBP Medical, the leading global developer of single-use, self-contained, illuminating medical devices, today announced the launch of its CLEAR-TRAC family of disposable surgical retractors. The line—which includes CLEAR-TRAC SP (surgical pocket), CLEAR-TRAC V (vaginal) and new CLEAR-TRAC B (breast)—is the first on the market to offer a built-in, single-use light source.

8 Jul 2015

Mindray announces definitive agreement to acquire remaining stake in Dragonbio for US$72.6 million

Mindray Medical International Limited, a leading developer, manufacturer and marketer of medical devices worldwide, announced today a definitive agreement to acquire the remaining stake in Wuhan Dragonbio Surgical Implant Co., Ltd. for approximately US$72.6 million.

From Mindray 7 Jul 2015

Bionik Laboratories successfully raises US$13.1 million in private placement transaction

Bionik Laboratories Corp., a medical device and robotics company with a core focus in robotic exoskeleton technology for users with mobility impairments, announced today that it has completed an additional sale to qualified accredited investors of units consisting of its common stock and warrants for aggregate gross proceeds of approximately US$1.4 million in a private placement transaction.

7 Jul 2015

Patients who receive intracranial stents at increased risk of experiencing another stroke

The risk of experiencing another stroke is higher if patients, after dilation of their blood vessels in the brain, receive not only clot-inhibiting drugs, but also have stents inserted. The recently published results of the VISSIT study confirm this conclusion of a rapid report by the German Institute for Quality and Efficiency in Health Care (IQWiG) of October 2014.

7 Jul 2015

WPI-led study provides clues to new ways to treat difficult-to-cure fungal infections

A study by a multidisciplinary research team, co-directed by Worcester Polytechnic Institute, offers new insights into how virulent fungi adapt through genetic modifications to fight back against the effects of medication designed to block their spread, and how that battle leaves them temporarily weakened. These insights may provide clues to new ways to treat notoriously difficult-to-cure fungal infections like thrush and vaginitis.

7 Jul 2015

Medical Devices News and Research

Biopharmaceutical companies still trying to find the best ways to measure effectiveness of CAPA processes

New benchmarking study reveals current corporate library services within biopharmaceutical industry

TSO3 obtains purchase orders from the US for STERIZONE sterilization system

NeoGraft selects Verasoni Worldwide as marketing communications partner

MediCollector to commercialize Wyss Institute's bedside data-acquisition software

New, nontoxic surgical glue helps heal wounds without scar or inflammation

Avita Medical’s unique regenerative technology offers hope for burn victims

Expanded use for IntelliCap with further CE Mark for aspiration of fluids

XIAFLEX approved in Japan for treatment of patients with Dupuytren's contracture

Melphalan granted FDA Orphan Drug Designation for treatment of cholangiocarcinoma

Mindray Medical announces completion of Wuhan Dragonbio acquisition

ForeverGreen Worldwide earns BSCG's anti-doping certification for PowerStrips

OphthaliX updates website to reflect proposed acquisition of Israel-based Improved Vision Systems

Researchers develop new approach for better integrating medical devices with biological systems

Amedica receives FDA feedback on proposed wear testing femoral head protocols

OBP Medical introduces CLEAR-TRAC family of disposable surgical retractors

Mindray announces definitive agreement to acquire remaining stake in Dragonbio for US$72.6 million

Bionik Laboratories successfully raises US$13.1 million in private placement transaction

Patients who receive intracranial stents at increased risk of experiencing another stroke

WPI-led study provides clues to new ways to treat difficult-to-cure fungal infections

Industry Focus - Medical Device eBook

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

Expanding access to NMR with the Fourier 80 Duo

Latest News