CorMatrix Cardiovascular, a leading medical device developer, today announced the receipt of three U.S. Patents for replacement heart valves that utilize unique biomaterial called extracellular matrix (ECM). The established leader in cardiac biomaterial, CorMatrix has more than 120 U.S. and international patent applications pending on various ECM-based compositions and structures.
MIT scientists have developed a new microchip that can quickly separate white blood cells from samples of whole blood, eliminating any preliminary processing steps—which can be difficult to integrate into point-of-care medical devices. The hope, the researchers say, is to integrate the microchip into a portable diagnostic device.
The U.S. Department of Defense awarded Danvers, Mass.-based device company NeuroLogica Corp. another year and a maximum of $12 million in a fixed-price radiological devices contract that may last as many as 7 years. The Philadelphia, Pa.-based troop support division of the DoD contracted NeuroLogica for the 3rd extension of a contract that can be renewed a maximum of 4 more times.
A collaboration between researchers at the U.S. Department of Energy’s Lawrence Berkeley National Laboratory and the University of Wisconsin-Milwaukee has combined Fourier Transform Infrared spectroscopy with computed tomography to create a non-destructive 3D imaging technique that provides molecular-level chemical information of unprecedented detail on biological specimens with no need to stain or alter the specimen.
Neurosurgeons at The Ohio State University Wexner Medical Center are among the first in the United States to successfully implant an MRI-safe spinal cord stimulator to help patients suffering from chronic back or limb pain. Neurosurgeons Dr. Ali Rezai and Dr. Milind Deogaonkar performed the surgery Aug. 5...
Hologic touted a new FDA clearance for its Single Energy Femur Exam, a test for finding rare, unusual femur fractures that pose a high risk to patients. The diagnostic exam is intended for patients that do not respond to bisphosphonates, drugs prescribed to prevent osteoporosis.
The welding of plastics using laser technology enables the rapid, clean result medical device manufacturers want. However, when welding clear or translucent plastics, additives must be used in order for the bond to occur. That is, until now. New laser technology enables these types of plastics to be welded without any additives being used.
ResMed got Wall Street's attention after posting record sales and income for its 4th quarter, but shares have dropped back down, and then some, since the initial rush last week. RMD shares were trading at $47.18 as of about 4 p.m. today, about 1% less than the $47.65 closing price the night before the company released its 4th quarter earnings.
Standex-Meder Electronics has announced that its MK02, MK11, MK21P, MK26, and MK27 series of reed sensors are now rated IP67. These five lines have achieved this demanding accreditation, which certifies that the sensors are both totally protected against dust and protected against the effects of immersion between 15cm and 1m.
EAO Corporation has improved end-user safety with the introduction of their new Series 04 Fail-Safe Emergency-Stop Switching Element. The innovative 'fail-safe' element will detect if the stop switch actuator becomes disconnected from the emergency stop actuator.
Medical Device OEM’s that have applied Norman Noble Inc.’s Design for Manufacturability services have realized substantial benefits. Costs and time-to-market are often cut in half with significant improvements in quality and delivery. These services are most effective when applied to projects that involve tight tolerances and exotic materials, including NiTinol.
Helix Medical has announced additional capabilities in thin-wall injection molding utilizing implantable PEEK and silicone materials. Other specialized molding services include implantable thermoplastic & silicone specialty components, biopharmaceutical components, and fully-automated molding of tight tolerance silicone bellows.
In Part 1 of this blog, I described the background and approaches StarFish Medical employed for more modern devices with a comprehensive technical file, giving five top tips. In Part 2, I now describe how we recertified for older devices where the available design documentation was less comprehensive.
Ocular Therapeutix, Inc. announced today that the U.S. Food and Drug Administration (FDA) has scheduled an Ophthalmic Devices Panel meeting on September 19, 2013 to discuss, make recommendations, and vote on the company’s Premarket Approval (PMA) Application for the ReSure Sealant.
Following the rigorous process required by the ISO community to validate quality management systems, EMCO High Voltage Corporation is now ISO 9001:2008 certified. EMCO High Voltage Corporation, a leading designer and manufacturer of high voltage power supplies, announced today that it has completed ISO 9001:2008 certifications.