5 digital health startups you need to watch in 2019

(Image from Unsplash)

Funding for digital health companies continues to rise, with 2018 the biggest year so far this decade, according to healthcare investment firm StartUp Health. Investors took a greater interest in machine learning, blockchain and artificial intelligence (AI).

Digital health funding was 14 times greater than it was eight years ago, when New York-based StartUp Health began tracking these investments. From 2017 to 2018, the average deal size grew by $6 million. Machine learning companies cut 66 deals to raise $940 million, an 80% increase in funding compared to 2017. Patient empowerment received the most funding of any function in 2018, $3 billion across 193 deals.

Here are five of the up-and-coming digital health companies to watch in 2019:

Get the full story on our sister site, Medical Design & Outsourcing.

DarioHealth touts updated diabetes management software

DarioHealth updated logo

DarioHealth (NSDQ:DRIO) said yesterday it launched a new version of its Dario system and DarioEngage platform.

The new V4.2.0 update to both digital health programs are intended to improve user engagement, lower barriers to behavioral change and to streamline the experience and process efficiency for both users and their coaches, the Israel-based company said.

Read the whole story on our sister site, Drug Delivery Business News

Report: Researchers create CT, MRI image-altering malware to expose vulnerabilities

A group of researchers have created a malware program designed to exploit vulnerabilities in computed tomography and magnetic resonance imaging equipment to add realistic, malignant-seeming growths to scans in a bid to draw attention to vulnerabilities in medical equipment networks, according to a Washington Post report.

Researchers Yisroel Mirsky, Yuval Elovici and two others at the University Cyber Security Research Center in Israel created the malware program for use in a blinded study involving real CT scans, according to the report.

A total of 70 images were altered by the malware and were able to fool three skilled radiologists into misdiagnosing conditions “nearly every time,” according to the Washington Post.

Radiologists examining the images with added cancerous nodules incorrectly diagnosed cancer 99% of the time, according to the report. For images with real cancerous nodules that were removed, radiologists judged the patients to be healthy 94% of the time.

After being informed that the images were altered, the radiologists were given a second set of 20 scans, half of which were altered, according to the Washington Post. The radiologists still diagnosed fake nodules as cancerous 60% of the time, and did not detect the removed nodules 87% of the time.

Researchers in the study also ran the test against a lung-cancer screening software tool and were able to trick the system into misdiagnosing the false tumors every time, according to the report.

While the study focused on lung cancer scans only, researchers said that the attack could work for brain tumors, heart disease, blood clots, spinal injuries, bone fractures, ligament injuries and arthritis, according to the Washington Post.

The malware could be used to modify random scans to create chaos within a hospital system, researchers said, or to target specific patients through the use of names or ID numbers, according to the report.

The vulnerabilities that allow the exploit to occur exist in the equipment and networks hospitals use to transmit and store imaging data, according to the Washington Post. Since the images aren’t digitally signed or encrypted, they can be altered without detection, researchers said.

“They’re very, very careful about privacy … if data is being shared with other hospitals or other doctors, because there are very strict rules about privacy and medical records. But what happens within the [hospital] system itself, which no regular person should have access to in general, they tend to be pretty lenient [about]. It’s not … that they don’t care. It’s just that their priorities are set elsewhere,” Mirsky said, according to the report.

The malware program would have to be either physically installed or downloaded off the internet to operate, according to the Washington Post. To test the viability of a direct installation, Mirsky conducted a test at a hospital in Israel, and was able to enter a radiology department and connect a malicious device to the network in only 30 seconds without anyone questioning his authorization to be in the area.

To prevent such attacks, Mirsky suggested that hospitals adopt end-to-end encryption across their picture archiving and communication systems and to digitally sign all images and make sure workstations verify the signatures and flag images that aren’t properly signed, according to the report.

FDA wants public input on AI-enabled device regulation

(Image from FDA)

The FDA today floated some ideas on how it might regulate medical devices armed with artificial intelligence — also known as software-as-a-medical-device (SaMD) — whose algorithms can change based on machine learning (ML) and possibly affect people in ways for which they were not approved or cleared. It is also asking for the public’s feedback.

To date, the agency has cleared or approved AI/ML-assisted devices whose algorithms have typically been locked before hitting the market. The FDA’s 20-page discussion paper includes a proposed regulatory framework for devices that have algorithms that can learn and change after the devices have been sold.

Get the full story on our sister site, Medical Design & Outsourcing.

Volpara expands distro deal with GE Healthcare

Volpara Solutions

Volpara Solutions said yesterday that it expanded its distribution agreement with GE Healthcare (NYSE:GE) to include the global distribution of its VolparaDensity software.

Wellington, New Zealand-based Volpara said that its VolparaDensity software is designed to analyze mammograms using machine learning to provide automated, objective and volumetric breast density assessments and a breast density category that correlates to BI-RADS 5th and 5th editions.

“There are still certain signs of breast cancer that are best seen on a mammogram, which is why the Invenia ABUS is used in addition to mammography. ABUS screening helps find cancers hiding in dense tissue. Accurate density measurements and quality imaging are very important in breast cancer detection. I encourage women to learn their breast density, understand their risk, and talk to their healthcare providers to get the personalized healthcare they need,” Dr. Joseph Russo of St. Luke’s University Health Network said in prepared remarks.

Volpara touted that the system has been the subject of more than 100 peer-reviewed papers and 250 publications, and said that it is currently

“We are excited to expand access to VolparaDensity as part of our product portfolio. Now, our customers outside the US will also have access to a proven technology that will help them identify women who may benefit from a supplemental screening modality, such as the Invenia ABUS,” GE Healthcare automated breast ultrasound GM Luke Delaney said in a prepared statement.

“We have had a very productive partnership with GE over the past several years. We are thrilled to expand our agreement beyond the US market, working with GE Healthcare to offer customers a well-researched and widely adopted breast density assessment tool to help them deliver excellent breast health care. Providing an accurate and consistent assessment of breast density is becoming increasingly important to identify women at high risk of developing breast cancer,” Volpara Solutions prez & CCO Mark Koeniguer said in a press release.

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Artificial intelligence and medicine: Is it overhyped?

Artificial intelligence raises exciting possibilities for healthcare, but are companies promising more than they can deliver?

artificial intelligence ai medicine medtech medical devices hype

[Original image from iStock]

AI could possibly fuel the future of medtech, enabling such thrilling innovations as implanted devices that instantly react to minute changes, software that can identify the best treatment options for individuals facing life-threatening conditions and fully-functioning autonomous surgical systems.

But artificial intelligence’s potential also comes with an incredible level of hype.

“AI has the most transformative potential of anything I’ve seen in my life, and I graduated medical school 40 years ago. It’s the biggest thing I’ve ever seen by far,” prominent cardiologist and author Dr. Eric Topol told our sister site Medical Design & Outsourcing. “But it’s more in promise than it is in reality.”

Get the full story on MDO. 

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Homeland Security details vulnerabilities in Medtronic ICD, CRT-Ds, CareLink devices

Medtronic logo updated

The U.S. Dept. of Homeland Security today released a medical advisory warning of exploits within a number of Medtronic (NYSE:MDT) implanted cardiac devices and associated equipment that could allow an attacker to affect the functionality of the devices or intercept transmitted sensitive data.

The vulnerability affects Fridley, Minn.-based Medtronic devices using its Conexus radio frequency telemetry protocol, according to the release, and requires only a low level of skill and adjacent access to exploit.

Successful exploitation could allow an outside actor to “interfere with, generate, modify, or intercept” the RF communication of the Conexus telemetry system, the HHS said.

To do so, an attacker would need an RF device capable of transmitting or receiving Conexus telemetry communication, to be in adjacent short-range of the products and for the products to be in states where RF functionality is active, according to the release.

Before the device is implanted and during follow-up clinic visits, Conexus telemetry sessions require initiation by an inductive protocol, the HHS said. Outside of those environments, the RF radio is only enabled for brief periods of time to support follow-up transmissions and “other operational safety notifications.”

The HHS warned that the Conexus telemetry protocol does not implement authentication or authorization, or encryption.

The exploit affects Medtronic devices that use its Conexus telemetry protocol, according to the warning. Affected devices include all models of the Amplia CRT-D, Claria CRT-D, Compia CRT-D, Concerto CRT-D, Concerto II CRT-D, Consulta CRT-D, Evera ICD, Maximo II CRT-D and ICD, Mirro ICD, Nayamed ND ICD, Primo ICD, Protecta ICD and CRT-D, Secura ICD, Virtuoso ICD, Virtuoso II ICD, Visia AF ICD, Viva CRT-D, the CareLink 2090 Programmer, the 2490C version of its CareLink Monitor and versions 24950 and 24952 of its MyCareLink Monitor.

Medtronic has implemented additional controls for monitoring and responding to improper use of the Conexus telemetry protocol by affected devices, according to the release, and is developing further mitigations that will require regulatory approval.

A Medtronic spokesperson said that to date, no cyberattack, privacy breach or patient harm has been observed or associated with the issues.

The company said that it is developing a series of software updates to better secure the wireless communication affected by the issues, with the first update expected to launch later this year, subject to regulatory approvals.

Medtronic said that it, and the FDA, recommend that patients and physicians continue to use the devices as intended.

Last October, Medtronic disabled internet updates for approximately 34,000 CareLink devices designed for accessing and programming implanted pacemakers due to cybersecurity vulnerabilities with the systems.

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Medical device cybersecurity: It’s time to get real

Medical device makers, regulators and healthcare delivery organizations are increasingly working together to strengthen cybersecurity. But are they doing enough?

[Original image courtesy of istockphoto.com]

[Original image courtesy of istockphoto.com]

Almost no one in the medtech industry disputes the vulnerability posed by cyberattacks. How to go about boosting security is another matter – one on which those stakeholders have recently stepped up their collaboration.

One group, the Healthcare & Public Sector Coordinating Council, thinks it has a solution: Health providers and other customers buying a connected medical device should be able to remotely access a cybersecurity bill of materials (CBOM) that would list all commercial, open-source and custom-code software. Available via remote access for customers, the CBOM would also include commercial hardware such as processers, network cards, sound cards, graphic cards and memory.

The council’s recently issued joint security plan calls for more vulnerability disclosures, notices of breaches, software and hardware upgrades and security patch availability. Companies would also need to notify customers before they end technical support for older devices.

“It’s this voluntary framework that establishes best practice for cybersecurity at a medical technology company,” council member Rob Suarez, director of product security at Becton Dickinson, told Medical Design & Outsourcing. “This joint security plan establishes the common ground which many medical device manufacturers, health IT vendors and healthcare providers agreed on.”

Some manufacturers have grumbled about providing hardware information in a CBOM, but an increasing number have pledged to publicly share vulnerability information should hackers breach one of their devices, including industry giants BD, Abbott, Siemens, Philips, Medtronic, Johnson & Johnson, Boston Scientific and Stryker.

Get the full story on our sister site Medical Design & Outsourcing. 

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Oberd launches AI-assisted tech for gathering outcome data

Patient-reported outcomes vendor Oberd said it has launched software designed to reduce a patient’s time in completing outcomes surveys for orthopedic procedures.

Patient-reported outcomes can help quantify the value of a healthcare provider’s services. Columbia, Mo.-based Oberd’s computer-adaptive test (CAT) software has been developed and validated for all of the outcomes surveys approved by the American Academy of Orthopaedic Surgeons (AAOS). The technology, which uses artificial intelligence (AI), has been used in both test and live settings by the Geisinger Health System and will be featured in an article in the Journal of Shoulder and Elbow Surgery, according to the company.

Get the full story on our sister site, Medical Design & Outsourcing.

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Fresenius wins FDA breakthrough device nod for fluid management software

Fresenius Medical CareFresenius (NYSE:FMS) said yesterday that it won FDA breakthrough device designation for its computer-assisted ultrafiltration control software intended to improve fluid management during hemodialysis.

The Waltham, Mass.-based company said that the software is designed to work with its newer hemodialysis machines using its CLiC device.

Fresenius said that with the software, it hopes to create a dialysis machine with embedded intelligent diagnostics to provide computer-assisted recommendations for achieving target levels of relative blood volume.

“This new software represents our commitment to driving innovation and aims to become an essential tool in reducing cardiovascular events for people living with kidney failure. Effective fluid management is critical to creating the best hemodialysis treatment possible for each individual. We are proud of this effort to further advance our proven Crit-Line technology,” renal therapies group prez Mark Costanzo said in a press release.

The company said that timelines for final development and approval of the computer-assisted ultrafiltration control software remains “uncertain given the nature of developing this complex and innovative technology.”

Earlier this week, Fresenius said that it’s planning a stock buyback of up to $370 million worth of its own shares.

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