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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Philips to pick up Carestream Health’s imaging IT biz

CarestreamCarestream Health said today that it inked a deal to deal its imaging IT business to Royal Philips (NYSE:PHG) for an undisclosed amount.

“We have had global success in providing radiology and enterprise imaging IT systems to help medical professionals provide quality care and enhance their operations,” Carestream HIS GM Ludovic d’Aprea said in prepared remarks. “By becoming part of Philips, the HCIS business will have a greater opportunity to thrive and grow. Both organizations share a commitment to meaningful innovation which is deeply embedded in each company’s culture. Customers will have access to a broader portfolio of healthcare IT solutions to simplify medical image management, enable effective collaboration and enhance patient care.”

“Philips partners with global healthcare providers to connect people, information and technology with the commitment to deliver on the Quadruple Aim of improved patient experiences, better health outcomes, improved staff experiences, and lower costs of care,” added Philips precision Dx chief Robert Cascella. “This acquisition will enhance our ability to provide flexible solutions to hospitals and health systems. The combination of our successful innovations in imaging system platforms, workflow optimization and artificial intelligence-enabled informatics, combined with Carestream’s cloud-based enterprise imaging informatics platform and complementary geographic footprint will provide a solid foundation to deliver on the promise of precision diagnosis.”

Rochester, N.Y.-based Carestream said it’s keeping its medical imaging, dental & industrial films, non-destructive testing and precision coating businesses.

“These established businesses have solid financial foundations, innovative technology platforms and have earned the trust of loyal customers around the world,” chairman, president & CEO David Westgate said. “Our focus will be on delivering innovation that is life changing – for patients, customers, channel partners, communities and other stakeholders – and we will grow the company for long-term success.”

The deal is expected to close during the second half of the year, Carestream said.

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At-home digital health: Here’s what you need to know

ResMed AirMini app at-home digital health

ResMed’s AirMini CPAP device includes an app for smart devices that provides insights including a 30-day therapy history and daily therapy score. [Image courtesy of ResMed]

Demand is increasing for at-home digital health systems, where sensors follow people’s health data and automatically turn them into real-time insights for themselves and their health providers.

From ResMed and its connected CPAP technology to Clarify Medical getting user feedback for its light therapy system for skin conditions, medical device companies have started to score successes in at-home digital health, according to Scott Thielman, CTO of Product Creation Studio (Seattle).

“We really need to focus on cultivating user experience — a great user experience that will be sticky, that will overcome the downsides of having to live with whatever this technology is in their lives. There’s design work there to be done that we really need to lean in to and focus on to keep these innovations successful,” Thielman said during the latest podcast at our sister site Medical Design & Outsourcing.

Go to MDO and listen to Thielman provide some solutions to common challenges medical device creators face in the at-home digital health world.

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Zoll Medical acquires EMS tech dev Golden Hour Data Systems

Zoll Medical

Zoll Medical said today that it acquired privately held healthcare-focused Golden Hour Data Systems for an undisclosed amount.

San Diego-based Golden Hour Data Systems develops and provides solutions for patient charting and revenue cycle management for the emergency medical services market.

“Zoll and Golden Hour Data Systems have been delivering complementary solutions to the EMS market for the better part of two decades. With this acquisition, we’ll leverage the best of both development organizations to bring the next generation of cloud-based EMS solutions to our customers. Now both high- and low-volume EMS agencies will be able to field the right blend of integrated patient charting, RCM, fire records management, and healthcare information exchange solutions. The Golden Hour acquisition, coming on the heels of our acquisition of Payor Logic, testifies to our commitment to continually optimize operational and financial efficiencies in healthcare,” Zoll data systems prez Alex Moghadam said in a prepared statement.

“Joining forces with Zoll will have an immediate positive impact on our combined customer bases. Golden Hour’s offerings are a natural fit with Zoll’s SaaS platform and will accelerate the goal of driving data interoperability in healthcare,” Golden Hour CEO & chair Kevin Hutton said in a press release.

In January, Zoll Medical won a $400 million contract with the U.S. Department of Defense to supply them with patient monitoring and capital equipment systems and accessories.

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How NeuroMetrix seeks to better relieve pain with AI

NeuroMetrix Quell 2.0 AI artificial intelligence pain relief

NeuroMetrix’s Quell 2.0 [Image courtesy of NeuroMetrix]

NeuroMetrix plans to add artificial intelligence to the latest iteration of its Quell transcutaneous electrical nerve stimulation (TENS) device.

AI will allow Quell 2.0 to tailor treatment to each individual user, according to the Waltham, Mass.–based based company.

Launched in September 2018 Quell 2.0 is 50% smaller and 20% more powerful than the original Quell, which debuted in 2015. Quell is worn on the leg regardless of the site of pain and is designed to send neural pulses to the brain that trigger a natural pain relief response in the central nervous system. Patients control the device and track their pain using a smartphone app. Quell 2.0 is available over-the-counter for about $300.

So how could AI help patients who use the device? NeuroMetrix chief commercial officer Frank McGillin recently discussed the decision to use AI and the future of Quell with our sister site Medical Design & Outsourcing.

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Can AI take medical device manufacturing to the next level?

Artificial intelligence could improve medical device manufacturing efficiency and reduce risk, but it’s still a work in progress.

artificial intelligence data analytics medical device manufacturing medtech

[Image from Unsplash]

Artificial intelligence is driving the world and our habits. Some of the world’s most well-known companies are using AI: Apple in Siri, Tesla in self-driving cars, Amazon in Alexa and even Netflix.

Now companies like machine-learning and AI consulting company Wovenware are bringing AI to medical device manufacturing and other advanced industries to make the process more efficient while reducing risk.

Artificial intelligence is the capability of a machine to perform tasks that would normally be done by a human. Through machine learning, computers are taking in troves of data and learning mistakes while enhancing the jobs of engineers in the manufacturing process.

“Engineers have more time to do the important work,” said Carlos Meléndez, COO and co-founder of Wovenware (San Juan, Puerto Rico). “They don’t have to worry about things that they will not be able to fix.”

For example, a predictive algorithm can gather data about a medical device that was taken out of a production line because of a problem with the device. Using data and performance records, AI can determine the probability of that particular device being scrapped. If the algorithm shows a 99% chance that the device is going to be scrapped, it won’t be sent to the engineering department. Engineers then have more time to dedicate to more important processes, said Meléndez.

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

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