FDA Publishes Guidance On Cybersecurity Risk Management For Medical Devices

The FDA has published new draft guidance on managing cybersecurity threats that could compromise networked medical devices. Though no direct harm has been known to have occurred from cybersecurity attacks on medical devices, vulnerabilities in networked medical devices  have been known for years and widely reported on. White-coat hackers have published detailed vulnerability reports demonstrating how pacemakers, insulin pumps, and surgical robots could all be remotely controlled, producing potentially deadly results. In August 2015, the FDA issued its first ever safety alert over a cybersecurity vulnerability in a widely used medical device. The safety alert notified health systems that Hospira’s Symbiq Infusion System contained software vulnerabilities that “could allow an attacker to remotely control the operation of the device, potentially impacting the prescribed therapy and patient safety.” In February 2013, the President issued a series of executive orders tasking government agencies with strengthening the nation’s infrastructure against cybersecurity threats. A second executive order issued in February 2015 expands upon that directive by encouraging the creation of a cybersecurity information sharing network where government agencies and private business could collaborate on potential threats.

FDA Publishes Guidance On Cybersecurity Risk Management For Medical Devices

In response to the increased threat to equipment deemed critical to public health and the national infrastructure, the FDA has issued its new draft guidance to provide medical device manufacturers additional information on how to manage and mitigate post-market cybersecurity risks. For pre-market risk mitigation, the FDA references a 2014 document outlining appropriate design, test, and validation steps that should be taken by medical device manufacturers prior to submitting devices for approval.

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University of Illinois Researchers Unveil Bioresorbable Brain Implants

A team of researchers from the Materials Research Laboratory at the University of Illinois at Urbana-Champaign, along with neurologists from Washington University School of Medicine and engineers from Pennsylvania State University, Purdue University, Northwestern University, and Korea University have published findings in Nature on new silicon-based implantable sensors that monitor temperature and brain swelling, but that do not need to be removed afterwards because each component is made from materials that are naturally broken down by the body over time.

University of Illinois Researchers Unveil Bioresorbable Brain Implants

The new sensors are smaller than a grain of rice and are made of dissolvable silicon that operate normally for a few weeks, and then are broken down and absorbed naturally by the body. The sensors monitor key biometrics and then wirelessly transmit the information to a receiver implanted just under the skin but over the skull. Researchers say the new sensors could initially replace traditional hardwired sensors used to monitor traumatic brain injury patients, but hope that they will eventually be developed to support a wider range of monitoring needs in other organ systems. Lead investigator John Rogers, who runs the Fredrick Seitz Materials Research Laboratory at the University of Illinois, explains ,"These kinds of systems have potential across a range of clinical practices, where therapeutic or monitoring devices are implanted or ingested, perform a sophisticated function, and then resorb harmlessly into the body after their function is no longer necessary."

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Soon-Shiong Launches Moonshot Cancer Project In Conjunction With President’s SOTU Address

During the President’s final State of the Union Address, he announced a new moonshot project to cure cancer that was compared with the effort to put a man on the moon. Vice President Joe Biden, who lost his own son to brain cancer in 2015, was tasked with spearheading the initiative. In a piece published just after the SOTU, Biden painted a broad plan with little detail for how he would go about eradicating cancer – the leading cause of death worldwide. In his plan, he briefly mentions that “immunotherapy, genomics, and combination therapies” are the key emerging fields that would be counted on to deliver the groundbreaking results promised in the speech.

Soon-Shiong Launches Moonshot Cancer Project In Conjunction With President’s SOTU Address

Just prior to the speech, a group of private industry heavyweights launched their own program, called “Cancer Moonshot 2020,” led by healthcare billionaire Patrick Soon-Shiong and operating under an organization called the National Immunotherapy Coalition. Biden’s relationship with Soon-Shiong started when his son was still battling cancer. Desperate for any treatment that might help his son, Biden reached out to Soon-Shiong to learn more about what was happening in cancer research and what could be done to hasten critical discoveries. Though Biden’s son did pass away in May, those early discussions between Biden and Soon-Shiong led to both the President’s SOTU declaration and the formation of Cancer Moonshot 2020.

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WebMD Sale Rumors Send Share Prices Up, Then Back Down Again

Financial Times published a rumor Wednesday suggesting that online health information vendor WebMD was shopping itself around for a potential buyer. Anonymous insiders were quoted as saying that UnitedHealth, Aetna, Walgreens, and CVS were all at least partially interested, and that discussions with potential buyers were ongoing. The news initially drove share prices up nearly 10 percent, as investors hoped to cash in on the premium WebMD would likely negotiate over its current-value share price.

WebMD Sale Rumors Send Share Prices Up, Then Back Down Again

Late Thursday morning, WebMD issued a statement refuting the story. The press release stated simply “WebMD Health Corp, the leading source of health information, today announced that in light of recent news reports, the Company is reporting that it is not currently in any negotiations to be acquired.” The result of the back and fourth was a volatile day for WebMD share prices. Shares opened at $58.03, up 9.5 percent over the prior day’s closing price of $53.21. Share prices hovered in the $56 to $58 range until just before 11am when the company issued a statement correcting the rumor. From there, share prices tumbled, passing the previous days closing price and continuing to fall an additional 7.7 percent to close at $49.12.

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AiCure Raises $12 Million Series A To Tackle Medication Adherence With AI

New York-based digital health startup AiCure announces that it has closed a $12 million Series A investment round led by New Leaf Venture Partners, with additional investments from Biomatics Capital, Pritzker Group Venture Capital, and Tribeca Venture Partners. The found is AiCure’s first equity-backed investment, having raised millions in early capital through NIH grants. The company launched in 2010 with the goal of building a smartphone app that could use a smartphone’s forward-facing camera, facial recognition algorithms, and other image recognition algorithms to directly observe patients taking their pills. The idea won AiCure six NIH grants, worth in total more than $7 million, which was used to develop and patent the technology that powers the platform. Now, with eleven patents and a viable platform ready to bring to market, AiCure has attracted investors hoping that it might succeed where many others have failed.

AiCure Raises $12 Million Series A To Tackle Medication Adherence With AI

AiCure has developed a novel approach to measuring medication adherence. The company uses a number of algorithms to verify that the correct patient is taking the correct medication at the correct time. Facial recognition confirms patient identity, while image recognition technology zeroes in and identifies the actual pill. Finally, motion detection algorithms watch the mouth and throat to confirm that the pill has been swallowed. It’s a slick, almost over-engineered approach that likely would not have come to be if the startup had been funded by VCs from its inception, but with $7 million in NIH grants and time to focus on development efforts, AiCure has turned out a polished and technologically impressive platform.

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