Swiss devicemaker Synthes faces trouble from two sides, with an FDA warning letter posted just days after the company was sued by the families of two patients who died on the operating table during illegal clinical trials.
After consulting with Justice Department prosecutors, the HHS Office of Inspector General (OIG) has found nothing to substantiate the FDA’s claim that it began monitoring nine employees’ emails only after hearing that confidential industry information had been leaked to the...
Reports of gastrointestinal complaints.
SALT LAKE CITY--(BUSINESS WIRE)--BSD Medical Corporation, a leading provider of medical systems that utilize heat therapy to treat cancer, announced today that the Company continues an aggressive rollout of its successful MicroThermXÂ® Microwave Ablation System equipment rental program throughout the U.S.
NAMSA Opens Office near Frankfurt for EU Clinical Trial & Regulatory Support NORTHWOOD, Ohio--(BUSINESS WIRE)--Mar 8, 2012-- NAMSA, a leading medical device research organization, recently announced the opening of its newest office near Frankfurt, Germany. Staff with regulatory and quality...
Avinger, Inc., a medical device manufacturer of innovative, multi-functional catheters for treating patients with Peripheral Artery Disease (PAD), announces the enrollment of the first U.S. patient in the CONNECT II global clinical trial. Dr. Ian Cawich of Arkansas Heart Hospital...
According to Millennium Research Group (MRG), the global authority on medical technology market intelligence, procedures for Left Atrial Appendage (LAA) devices, intended to minimize stroke risk in patients with atrial fibrillation, have grown by over 200 percent in Germany since 2010.
Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: Norovirus Serological ReagentsMarch 8, 2012 5:30 am | by U.S. Food & Drug Administration | News | Comments
This special controls guidance document was developed to support the classification into class II (special controls) of norovirus serological reagents. These devices detect norovirus antigens in human fecal specimens as an aid in the diagnosis of...
Soft tissue imaging with 3D ultrasound both at therapy simulation and just before treatment has transformed prostate radiotherapy at University Hospital Galway (UHG). The majority of radiotherapy patients with prostate cancer who visit the clinic will benefit from a new technology...
Summary Information for: ION? Paclitaxel-Eluting Coronary Stent System (Monorail and Over-the-Wire Delivery Systems)March 7, 2012 6:30 am | by U.S. Food & Drug Administration | News | Comments
Labeling, Approval Order, and Summary of Safety and Effectiveness for ION? Paclitaxel-Eluting Coronary Stent System (Monorail and Over-the-Wire Delivery Systems) (P100023S015).
Summary Information for: Resolute MicroTrac Zotarolimus-Eluting Coronary Stent System (Resolute MicroTrac) and Resolute Integrity Zotarolimus-Eluting Coronary Stent System (Re...March 7, 2012 4:30 am | by U.S. Food & Drug Administration | News | Comments
Labeling, Approval Order, and Summary of Safety and Effectiveness for Resolute MicroTrac Zotarolimus-Eluting Coronary Stent System (Resolute MicroTrac) and Resolute Integrity Zotarolimus-Eluting Coronary Stent System (Resolute Integrity) (P110013).
Mayo Clinic today announced that Mayo Medical Laboratories has signed an agreement with A&G Pharmaceutical, Inc. and will receive a non-exclusive license to certain patent rights and proprietary antibody reagents for the detection and measurement of progranulin in blood.
The Breast Companion® Software System is a computer-aided report-generating system intended to improve the ACR BI-RADS® (American College of Radiology, Breast Imaging Reporting and Data System) assessment of ultrasound images of lesions of the...
Labeling, Approval Order, and Summary of Safety and Effectiveness for Breast Companion® Software System (P100007).
Medtronic, Inc. today announced the receipt of CE Mark (ConformitÃ© EuropÃ©enne) and launch of the CapSure Sense MRIâ„¢ SureScanÂ® pacing leads, which are approved for use during Magnetic Resonance Imaging (MRI). Medtronic introduced the first MR-Conditional pacemaker system in the world in 2008 and in the U.S. in 2011.
Covidien, a leading global provider of healthcare products, today announced that the Solitaireâ„¢ FR revascularization device has been cleared by the U.S. Food and Drug Administration. The Solitaire FR device is intended to restore blood flow to the brain in patients suffering acute ischemic stroke by mechanically removing blood clots from blocked vessels.
Amedica Corporation, a spinal and reconstructive implant and instrument manufacturer, focused on proprietary silicon nitride (Si3N4) ceramic technologies, announced today the launch of a new spinal implant called Procetâ„¢. Procet has been designed to treat patients who suffer from low back pain...
Houston Medical Robotics, Inc. announces that it has received U.S. Food and Drug Administration 510(k) clearance to market the Euclidâ„¢ Tier 1 Mini Access System. The Euclidâ„¢ Tier 1 Mini Access System is a portable, hand-held device that integrates commercially available...
Biosensors are critical components of diagnostic devices. They are tiny, integrated circuit chips that transmit readings from within the body to an external component that displays data for physicians and patients. Biosensors have many applications including important roles in continuous glucose monitors, sensors that monitor cell health, and magnetic sensors associated with microlabels and microfluidic cartridges, just to name a few. A big obstacle facing biosensors that are implanted into the body is longevity.
Labeling, Approval Order, and Summary of Safety and Effectiveness for Ovation Abdominal Stent Graft System (H100008).
The OVATION abdominal stent graft system is used to treat abdominal aortic aneurysms during endovascular repair (EVAR). An aneurysm is a diseased, bulging, weak section of an artery wall; in this case the aorta. The main portion of the OVATION abdominal..
Cardiac Science Powerheart, CardioVive, CardioLife; GE Responder and Responder Pro; and Nihon-Kohden Automated External Defibrillators (AEDs): Class I Recall - Defective Compo...March 2, 2012 2:31 pm | by U.S. Food & Drug Administration | News | Comments
Unexpected component failure may lead to AEDs not delivering defibrillation therapy, causing serious adverse health consequences, including death.
Class I Medical Device Recall: Cardiac Science Powerheart, CardioVive, CardioLife; GE Responder and Responder Pro; and Nihon-Kohden Automated External Defibrillators - AEDsMarch 2, 2012 7:30 am | by U.S. Food & Drug Administration | News | Comments
The affected AEDs contain a component that may fail unexpectedly due to a defect. If the component were to fail during a rescue attempt, the AED may not deliver defibrillation therapy causing serious adverse health consequences
SurModics' Hydrophilic Coating on Medtronic's Resolute IntegrityT Drug-Eluting Stent Delivery SystemMarch 1, 2012 11:45 am | by The Associated Press | News | Comments
SurModics' Hydrophilic Coating on Medtronic's Resolute IntegrityT Drug-Eluting Stent Delivery System EDEN PRAIRIE, Minn.--(BUSINESS WIRE)--Mar 1, 2012-- SurModics, Inc. (Nasdaq: SRDX), a leading provider of surface modification and in vitro diagnostic (IVD) technologies to the healthcare...
Statins and HIV or Hepatitis C Drugs: Drug Safety Communication - Interaction Increases Risk of Muscle InjuryMarch 1, 2012 11:30 am | by U.S. Food & Drug Administration | News | Comments
Protease inhibitors and statins taken together may raise the blood levels of statins and increase the risk of myopathy, kidney damage, and kidney failure, which can be fatal.