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!
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: Corista, Corista DP3, Digital pathology, medical device
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Exciting news for MBBP client Corista as Johns Hopkins Medicine, one of the leading health care systems in the United States, has successfully installed Corista’s DP3 system. The DP3 is a digital pathology network platform that removes the physical boundaries from pathology and enables real-time remote expert diagnoses. It is a workflow solution integrating multiple facilities, scanners, physicians, patients and Laboratory Information Systems.
Johns Hopkins is standardizing this DP3 system as its centralized digital pathology platform in order to streamline workflows among its five hospital centers. The overall objective is to provide more efficient and accurate flow of information across core systems that manage diverse functions in the hospital system. Specifically, the system will help improve each hospital’s Tumor Board process, integration of existing systems including LIS, and global remote access.
Congratulations, Corista! MBBP serves as general counsel to Corista and assisted in negotiating its contract with Johns Hopkins. For more information, visit Corista News & Events.
Tags: boston scientific challenge, caregiver, device, elderly care, health, medical device, technology, watchrx, wearables
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MBBP client WatchRx, is an early stage startup founded while trying to help aging parents manage their medications and health conditions remotely. Current solutions available in the market, like mobile apps and pill caps/bottles, didn’t fit the need and only added to the confusion. WatchRx provides a a simple dedicated reminder solution. From voice reminders to GPS tracking this device addresses so many needs. The watch can even send alerts to family and caregivers.
The Boston Scientific Connected Patient Challenge is an open competition focused on ideas and early-stage companies that improve patient care and/or drive down the cost of health care through the use of Remote Patient Monitoring using wearable, implantable or ubiquitous sensors. The top five ideas based on the online crowd voting and online judge scores were honored at a live event on February 25, 2016, where they presented their ideas to the Challenge Sponsors and fellow participants. Arun Buduri, Founder and Chief Product Officer, presented for WatchRx and walked away the winner! Watch the pitch (skip to 56:45) and award (skip to 1:53:00) here.
This isn’t the only thing the Greater Boston-based company is celebrating. Just yesterday WatchRx Founder and CEO Jayanthi Narasimhan was awarded 2016 Women to Watch in Science & Technology by the Boston Business Journal.
Congrats to WatchRx. If you aren’t a client to “watch” we don’t know who is!
Tags: FDA, LifeScience Alley, MDIC, medical device
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The FDA issued a press release December 3, 2012 announcing its role in a new public-private partnership aimed at expediting medical device review and approval by improving the regulatory science underlying medical device development, assessment and review. In particular, the biomedical science trade association LifeScience Alley (LSA) created the Medical Device Innovation Consortium (MDIC) as an independent, nonprofit corporation that will garner input from stakeholders, including industry, government, and other nonprofit organizations to better understand the regulatory science needs of the medical device industry and provide funding for projects that will simplify medical device design and market approval. The FDA plans to collaborate with MDIC on its supported research and projects.
For additional information, please contact David A. Fazzolare.