News Archive

mHealth advocates are giving good early reviews to the U.S. Food and Drug Administration’s final guidance document on the regulation of mobile medical apps, with one expert calling it “an expansive document that truly seeks to deregulate our nimble and innovative industry, while ensuring patient safety.”

“The guidance goes much further than I thought it would,” said Robert Jarrin, senior director of government affairs for Qualcomm, who noted that the agency has taken a new and novel approach in launching a consumer-facing website with an adjoining list of regulated apps that may be updated on a regular basis. In addition, he said, the FDA is creating a team that will be tasked with answering public inquiries about mobile medical apps submitted through mobilemedicalapps@fda.hhs.gov.

October 1 and 2, 2013 8:00pm ET/5:00pm PT

Now on its eighth run, the NIH SBIR Phase I Program for First-Time Applicants is a very practical step-by-step, four-hour online “How-To” workshop over two evenings to help researchers, faculty members, graduate students, post-docs and entrepreneurs create a SBIR company and apply to the NIH SBIR program in December of 2013. This workshop includes a post-course review of the applicant’s proposed SBIR application by our experts before submission to the NIH. As an added benefit, your SBIR companies will be included on NCET2’s newsletters that is sent out to VCs, angel investors, Global 1000 companies, and government funders.

The NIH SBIR/STTR program is one of the federal government’s best mechanisms to continue funding innovative life science research after traditional research funding has been exhausted. The objective of the program is to dramatically increase the impact of innovations derived from original federally funded R&D, and as such is an ideal program to fund university commercialization of research through new university/faculty/student startup companies. Phase I can be for up to $150,000 for 6 months. Phase II can be for up to $1 million for 2 years. After Phase I and II, the company should have eliminated enough technical and scientific risk of the original research that the company is ready for outside investor funding or product sales in the company sustainability final Phase III of the SBIR program.

Something as mundane and common as giving and receiving compliments may be a serious challenge if you are an immigrant.

Over the years, I have learned, often the hard way, the essential importance of receiving and giving compliments, at home, at work, and in social or semi-social environment. Generally speaking, East Asian cultures tend to be more reserved in expressing appreciations or affection toward others compared to the American culture (some generalization here).  We have all heard of such jokes about Asian parents singling out the only “B” in the child’s report card amidst all other “A”s and demand to know why the child had failed to get straight “A”s, while American-born parents would emphasize on the progress or efforts rather than the outcome.

Health IT groups and mobile application developers’ reaction to FDA’s release of final guidance for mobile health apps is mixed, the Baltimore Sun reports (Wells/Clarke, Baltimore Sun, 9/23).

Details of Final Rule

According to the final guidance issued Monday, FDA will focus oversight on apps that:

• Were developed to be used as accessories to regulated medical devices, such as apps that allow health care providers to make diagnoses by viewing medical images on smartphones or tablets; or 
• Can transform mobile devices into regulated medical devices, such as apps that allow a smartphone to be used as an electrocardiography machine (iHealthBeat, 9/23).

The United States Food and Drug Administration has finally released guidelines on how it plans to regulate thousands of new health-related smartphone applications.

After months of delaying its decision, the agency has determined that the vast majority of these health-related apps pose a negligible threat to consumers. Most of these “mobile medical” apps do not need federal regulation, the FDA found, so developers and investors can breathe a bit easier.

Wednesday, October 30, 2013
8:30 AM to 11:30 AM

Do you love health technology? Do you want to learn more about it? Do you want to teach others and collaborate with local experts?

Call it what you want–mobile health, digital health, health IT–it’s all about using innovative technology to improve the lives of you, me, and the people we care about. Let’s build an ecosystem dedicated to making health technology part of everyday life and the standard of care! Being located in the Maryland area, we have all the pieces to the puzzle to promote innovation, collaboration, and investment in an industry that will revolutionize healthcare and impact the lives of all 7+ billion people around the world.

Join our ecosystem for the MD HealthTech Coalition Kickoff Event and hear from a panel of experts about the challenges, opportunities, and innovative solutions. More details to follow…

How can you tell Maryland is becoming a hotbed for cyber security business?

Ellen J. Hemmerly said it’s obvious from the companies looking into University of Maryland, Baltimore County’s technology incubator.

“We’re attracting not only local and regional entrepreneurs,” Hemmerly said. “We’re getting more and more inquiries and tenants from out of state.”

Montgomery County’s largest biotechnology company, which is celebrating its 25th anniversary this week, actually hatched from a meeting in the Big Apple.

In the late 1980s, Wayne T. Hockmeyer was an executive with Praxis Biologics in Rochester, N.Y., with an inkling to branch out on his own. He had spent two decades in the U.S. Army, including as chairman of the Department of Immunology at Walter Reed Army Institute of Research in Washington, D.C., from 1980 to 1986.

The state’s two major research institutions, Johns Hopkins University and the University of Maryland, College Park , are partnering to build a research and science center in East Baltimore opening September 2014. The state is spending $27 million and Hopkins is contributing $3 million toward the $30 million public/private venture whose goal is to make Maryland’s universities and private industry more competitive in the sciences.

The High Performance Research Computing Facility will consist of multiple buildings on land leased from Hopkins on its 350-acre Bayview Medical campus, at 4940 Eastern Ave. Expected to break ground in November, the center will be set off from other buildings and have its own separate entrance. The universities will finish site design this month and then bid the project to vendors. 

GlaxoSmithKline announced on Thursday that it has signed a four-year contract with the Biomedical Advanced Research and Development Authority for the provision of its inhalation anthrax treatment, raxibacumab.

In the new contract, GSK will give the United States government 60,000 doses of raxibacumab over a four year period. The estimated value of these shipments total $196 million.