In June 2013, Medtronic, Inc. (NYSE: MDT) initiated four medical device notifications to customers worldwide about the SynchroMed® Implantable Infusion System. These notifications provide clinicians with information to help identify and manage issues that impact the safe and reliable delivery of therapy using the SynchroMed Implantable Infusion System.
Soon, women in Europe may be taking a new look at one of the world’s oldest forms of contraception. European regulators have granted the single-size SILCS Diaphragm a CE marking, allowing the product to be sold throughout Europe. The launch is also an important step toward expanding nonhormonal contraception options for women worldwide.
Axio Biosolutions Private Limited, a medical device designer and manufacturer company is proud to announce that it has obtained the European Union Class III Medical Device CE mark approval for its range of Emergency Haemostatic Dressing - AXIOSTAT. The CE mark designation will allow AXIOSTAT to be sold in the European Union and other countries.
Tangent Medical, an innovator in IV therapy products and creator of the NovaCath Integrated IV Catheter System, announced today its commercial product launch and start to clinical evaluations in several healthcare facilities across the U.S. The commercialization of this product is the first significant advancement in the IV catheter market in more than a decade.
Middle Peak Medical, a development-stage medical device company that will commercialize a novel technology for treating mitral valve disease, has raised $8.5M in a Series A financing. The round was co-led by healthcare investment specialists Wellington Partners and Seventure Partners, along with seed investor High-Tech Gründerfonds Management GmbH (HTGF).
Scientists in the US have developed a novel vaccination method that uses tiny gold particles to mimic a virus and carry specific proteins to the body’s specialist immune cells. The technique differs from the traditional approach of using dead or inactive viruses as a vaccine and was demonstrated in the lab using a specific protein that sits on the surface of the respiratory syncytial virus (RSV).
Padilla and researchers in his lab recently reported a breakthrough in efforts to create accessible and effective THz imaging. Using both optical and electronic controls, the team developed a single-pixel imaging technique that uses a coded aperture to quickly and efficiently manipulate stubborn THz waves, according to a recent report in the journal Optics Express.
The Biozoom scanner non-invasively measures and analyzes the biomarkers critical to understanding, managing, and improving a user's health and wellness. The prototype units have been validated in clinical trials and used at respected European institutions. The first commercially produced scanners are expected to arrive in September.
Medspira Announces New Clinical Trial Utilizing Its Innovative mcompass Biofeedback Anorectal Manometry System for Treatment of Fecal IncontinenceJune 26, 2013 9:00 am | by Business Wire | Comments
Medspira announces a multi-center randomized clinical trial utilizing an investigational biofeedback device (based on the FDA cleared and currently marketed mcompass Anorectal Manometry system) combined with pelvic floor physical therapy for treatment of fecal incontinence.
Qardio Unveils Daily-Wear, Wireless Devices for Continuous Health Monitoring by Consumers & Their PhysiciansJune 26, 2013 7:00 am | by The Associated Press | Comments
Qardio, a healthcare technology company, today unveils two revolutionary, cardiovascular monitoring devices. QardioCore and QardioArm are elegantly designed for effortless daily-wear, continuous monitoring by those with, or at risk of developing, cardiovascular conditions and sharing of data...
New Clinical Study Launches to Evaluate Healing of Knee Cartilage Using a Patient’s Own Regenerative CellsJune 26, 2013 6:00 am | by Business Wire | Comments
InGeneron, Inc., an innovator in cell-based technologies for healthcare and veterinary medicine, announced today a study to assess the use of adult adipose derived regenerative cells to enhance cartilage healing after knee surgery. The study will utilize InGeneron’s patented Transpose RT system to prepare regenerative cells from the patient’s own fat tissue.
These are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions. This list is generated on a monthly basis. A PDF document that contains the "Approval letter and Summary of Safety and Effectiveness" is being added to this listing for each PMA. The PMA number will appear as a link if this document is available.
Various areas of the brain process our sensory experiences. How the areas of the cerebral cortex communicate with each other and process sensory information has long puzzled neuroscientists. Exploring the sense of touch in mice, brain researchers from the University of Zurich demonstrate that the transmission of sensory information from one cortical area to connected areas depends on the task to solve and the goal-directed behavior.
What if experts could dig into the brain, like archaeologists, and uncover the history of past experiences? This ability might reveal what makes each of us a unique individual, and it could enable the objective diagnosis of a wide range of neuropsychological diseases.
Aethlon Medical, Inc. (OTCQB: AEMD), announced today that the United States Food and Drug Administration (FDA) has approved an Investigational Device Exemption (IDE) that allows the Company to initiate human feasibility studies of the Aethlon Hemopurifier@ in the United States. The...