A group of cybersecurity and life science CEOs will be charged with finding ways to help grow the industries in Maryland, Gov. Larry Hogan has announced. The initiative, called Excel Maryland, is designed to help keep startup biotech and cybersecurity companies in Maryland.
A Ponemon Institute and Synopsys survey revealed that only 17% of medical device manufacturers and 15% of health care delivery organizations are implementing steps to address cybersecurity issues, while only 9% of manufacturers and 5% of HDOs test their medical devices at least annually and 49% of manufacturers were not using FDA guidance on medical device security. Meanwhile, no fewer than 8,000 known vulnerabilities were found in seven pacemaker programmers from four different device manufacturers that "highlights an industry wide issue associated with software security updates," according to a WhiteScope report.
TEDCO, an agency that supports Maryland's innovation economy, recently handed out its 2017 Innovation, Corporate Excellence and Entrepreneurship awards. An award for innovation went to Light Point Security, while Paragon Bioservices received a corporate excellence award, and Wendy Perrow of Asclepix Therapeutics and Elie Ashery of Gold Lasso won entrepreneurship awards.
Anticipating Food and Drug Administration approval for its rice-size, implantable glucose monitor this year, Germantown-based medical device company Senseonics Holdings has received $41 million to be used commercializing the invention.
A report released by the Government Accountability Office indicated the need for a more proactive stance by HHS in handling potential infectious disease outbreaks such as Zika. The report cited challenges faced by the agency such as continued research, vaccine approvals, budget constraints for surveillance, data collection, information dissemination and staffing.
The FDA does not have to speed up its approval process for medical devices and instead should focus on ensuring the efficiency of the device-development process so that safe products are produced and postmarket recalls are avoided, agency Commissioner Scott Gottlieb said in a hearing held by a House Appropriations subpanel. Gottlieb added that the FDA has lifted its hiring freeze, allowing it to increase the number of experts for product reviews.
The Fort Detrick laboratory that takes the lead in analyzing bioterror and biocrime attacks could be shut down under the budget proposed by President Donald Trump. If the closing happens in 2018 as suggested, approximately 180 employees could lose their jobs.
Legislation that would reauthorize user fee programs for medical devices, pharmaceuticals, generic drugs and biosimilars has cleared the House Energy and Commerce health subcommittee. The panel has agreed to all four amendments of the bill, including provisions for over-the-counter hearing aids and improvements on the medical device inspection process.
The Maryland Association of Certified Public Accountants, working with IBM, is giving members training on technology such as artificial intelligence and data science. The e-learning courses come through IBM's Big Data University and also include subjects such as blockchain and cognitive computing.
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