Tags: FDA, fetal heart monitor, fetal monitor, fetal monitoring system, medical device, medical devices, medical technology, MERIDIAN M110, mindchild, U.S. Food and Drug Administration
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MindChild Medical, Inc., a client of MBBP, has received FDA clearance for its Pre-Marketing Notification (510(k)) for its MERIDIAN™ M110 non-invasive fetal heart monitor. The FDA clearance will enable MindChild to enter the U.S. market with MERIDIAN™.
MindChild’s MERIDIAN™ M110 Fetal Monitoring System is an intrapartum fetal monitor that externally measures and displays fetal heart rate, maternal heart rate, and uterine contractions.
Congratulations to MindChild on this achievement!
Tags: boston children's hospital, david scadden, Harvard, harvard university, magenta therapeutics, massachusetts general hospital, medical field, medical technology, medicine, mgh, regenerative biology, stem cell, stem cell research, technology
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Harvard University has recently completed a license agreement with Magenta Therapeutics, a newly launched start-up in Cambridge, Massachusetts, in order to continue research and development related to new approaches to blood stem cell transplantation. The deal will help transform this science from that of a “last resort” into safer, more effective therapy for patients who suffer from blood diseases, cancers, and immune disorders. The license agreement has given Magenta the opportunity to utilize a platform of technologies developed at Harvard, Massachusetts General Hospital (MGH), and Boston Children’s Hospital.
This revolutionary technology has been most recently advanced in the laboratory of David Scadden, the Gerald and Darlene Jordan Professor of Medicine and professor of stem cell and regenerative biology at Harvard, and director of the Center for Regenerative Medicine at MGH. Scadden’s lab has made advances in how donor cells are selected, harvested, and prepared for transplant, improving projected outcomes for patients. For more information, read the Harvard Gazette and Boston Business Journal articles.
Interview with MBBP Client Valeritas Included in Wall Street Transcript Medical Devices Report 08/09/2016Posted by Morse, Barnes-Brown Pendleton in Client News, Intellectual Property, Life Sciences, Medical Devices.
Tags: Diabetes, insulin delivery, Intellectual Property, ip, John Timberlake, medical device, medical devices, medical technology, patent, type II diabetes, V-Go, Valeritas, wall street transcript
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The most recent Wall Street Transcript Medical Devices Report includes an interview with Valeritas, Inc.’s CEO, John Timberlake. Timberlake discusses in detail Valeritas’s V-Go Disposable Insulin Delivery Device. The V-Go is a wearable basal-bolus insulin delivery device that allows patients to deliver insulin at a continuous preset basal rate, with bolus delivery as needed. The V-Go has been cleared for use in the United States and in Europe. The fact that V-Go is a wearable product with scheduled insulin delivery enables patients to more easily go about their daily routines without having to stop to deliver insulin, and also allows them to discreetly deliver insulin during mealtimes without drawing attention to the act.
Valeritas is a commercial-stage medical technology company that develops new Type II diabetes technology products aimed at improving the lives of patients with Type II diabetes. For more information about Valeritas and its V-Go product, read the full interview with The Wall Street Transcript.
Tags: client, clinical study, ConforMIS, employment law, joint replacement implants, knee replacement, medical technology
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ConforMIS, Inc., a medical technology company that manufactures and sells joint replacement implants, received positive results from its iTotal CR study. The iTotal CR is a fully customized implant for use in total knee replacement, and the study found that 92% of patients were satisfied with the product in the year after receiving a knee replacement.
In developing, manufacturing, and selling joint replacement implants, ConforMIS uses its iFit Image-to-Implant technology, which allows for a customized implant specifically designed to fit an individual’s anatomy. The iTotal CR study included 300 patients in the United States, and is still ongoing. The interim study results were presented at the 2016 SICOT International Orthopaedic “Specialized Knee Surgery” Conference in Germany, which ran from June 30th to July 2nd.
The positive feedback is consistent with a previous study that showed that patients noted significantly higher satisfaction with the ConforMIS iTotal CR in their knee replacements, than with off-the-shelf implants. The positive results speak to the benefits of anatomically customized implants, and illustrate how ConforMIS’s products are making a positive and lasting impact in the joint replacement implant market.
To read more about the study and ConforMIS’s technology, read the full article.