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Heartburn: Yet Another Device-Maker Is Facing Cardiac Device Cybersecurity Worries – This Time, It's Medtronic
Medtronic cardiac devices are vulnerable to malicious hackers who could potentially not only intercept data between the patient and their provider, but also may be able to manipulate the implantable cardiac devices, possibly leading to serious adverse events and death. US FDA says patients should continue to use the devices as usual but should look out for telltale signs of an attack. Meanwhile, Medtronic claims it was aware of the issue and contends that patients shouldn't be concerned: “To date, no cyberattack, privacy breach, or patient harm has been observed," a spokesman says.
German serial entrepreneur Michael Orlowski achieved a successful exit in his first cardiovascular device company, EuroCor, by selling not to a US-based giant, but to an Indian conglomerate, Opto Circuits. His new company, Cardionovum, has developed a next-generation drug-eluting balloon whose novelty rests on a different approach to the coating technology designed to produce better drug-elution. With CE mark in hand, Cardionovum is preparing to launch its products in Europe. The US is a logical next target, but the high cost of clinical trials and the ever-lengthening regulatory approvals process has made the US an even more difficult market to penetrate, forcing companies like Cardionovum to contemplate strategies that bypass or put off a US launch.
EBI’s device team reviews of the top news stories in the medical device industry in 2011. Top stories include: 510(k) reform, user-fees, VC money dries up for medtech, hot clinical spaces of the year, where private investment dollars went in 2011, big changes at J&J, and the new physician/hospital alignments and their impact on the medical device industry.
The convergence of expanded access, lower reimbursement rates, higher velocity of innovation, diminished pools of venture capital, the advent of personalized care and a growing demand for improved patient outcomes has created ripples that already are altering the economics and operating dynamics of health care. To survive the coming storm, biomedical companies must build new models of innovation that are anchored in consumer-centric disease solutions rather than the traditional R&D department approaches.
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