MobileODT touts colposcope-based cervical cancer detection AI


MobileODT said last week that it is implementing a new artificial intelligence algorithm in its EVA system Colposcope that it claims can detect cervical cancer more effectively than existing testing.

The new technology, known as Automated Visual Evaluation, has been validated by the National Cancer Institute and the National Library of Medicine, the Israel-based company said, and is able to identify problematic lesions with greater reliability than traditional Pap Cytology testing.

MobileODT said that it is working with the NCI and other researchers to continue validating the AVE algorithm, and that it is launching a large scale pilot looking to validate the clinical application of the AVE algorithm with partners at India’s Genworks Health and Apollo Hospitals.

In the study, researchers will investigate the use of the AI algorithm in detecting cervical cancer in up to 250 women, the company said. It is hopeful that data from the trial will help improve the effectiveness of the AVE tech.

“We are excited by the new AVE algorithm and the promise it holds in fighting cervical cancer. Our team is proud to make available an AVE enabled colposcope to reach more women and save more lives,” CEO Ariel Beery said in a press release.

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Medtronic launches MyCareLink Heart pacer-connected smartphone app

Medtronic logo updated

Medtronic (NYSE:MDT) said today that it launched its MyCareLink Heart mobile application intended to connect users’s smartphone devices directly to the company’s portfolio of connected pacemakers, touting it as the first such mobile application of its kind.

The newly launched application is compatible with all of the Fridley, Minn.-based medical giant’s BlueSync technology-enabled pacers, and can wirelessly send device data to the company’s CareLink network, eliminating the need for dedicated bedside monitors and other remote monitoring tech.

“For the first time, pacemakers have the ability to communicate securely and directly with technology that patients use every day like smartphones and tablets. This brings the benefits of remote monitoring seamlessly into patients’ lives, potentially leading to enhanced and more efficient patient engagement with their physicians,” connectivity & insights biz GM Aisha Barry said in a press release.

Data collected by BlueSync-enabled pacers is encrypted and sent to the CareLink network through the mobile app, allowing physicians to monitor patients and receive alerts on clinically-relevant events, the company said.

The newly launched app also features the ability for patients to explore information about transmissions sent to their doctors and to receive confirmations of transmissions, track their vital signs and physical activity, display remaining battery life and catalog symptomatic events to be reviewed by physicians.

“The MyCareLink Heart mobile app is a technological game-changer for people with pacemakers. The introduction of convenient and secure data transmissions and easy access to information like pacemaker battery life changes how patients track and understand their heart health,” Dr. James Allred of Greensboro, N.C.’s Cone Health Medical Group Heartcare said in a prepared statement.

Earlier this month, major medtech players Medtronic and Boston Scientific (NYSE:BSX) said they will continue to support the use of their paclitaxel-eluting devices in the legs after a study released last month indicated a link between the devices and an increased mortality rate.

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Image analysis dev Koios Medical raises $5m

Koios Medical

Medical image analysis dev Koios Medical raised $5 million in a new round of equity financing, according to a recently posted SEC filing.

Koios is developing an ultrasound imaging software platform that uses artificial intelligence and machine learning to provide decision support for use in diagnosing cancer, according to the company’s website.

The company’s flagship product is the Koios DS for Breast, a breast cancer diagnostic assistant. The system has won FDA clearance and is hardware agnostic, Koios said.

The company is seeking an additional $6 million in the round, which would take the total raised up to $11 million, according to the filing.

Money in the round came from a single anonymous investor, with the first sale dated as having occurred on December 28, 2018, according to the filing.

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FDA: Medtronic select recall of Synergy, Stealth Station S7 cranial software is Class 1

Medtronic logo updated

Medtronic (NYSE:MDT) is recalling select Synergy and StealthStation S7 cranial software used with its StealthStation surgical navigation system over reports of incorrect information being displayed during biopsy procedures in a recall action labeled by the FDA as Class I.

Class I designations, the FDA’s most severe classification, are used when there is a reasonable probability that product use could cause serious adverse health consequences or death.

The cranial software is intended for use with Fridley, Minn.-based Medtronic’s StealthStation Surgical navigation system and provides detailed 3D images of a patient’s brain to aid in navigation during neurosurgery.

According to the recall notice, during biopsy procedures the software monitor may show that the tip of the surgical tool has not yet reached the planned target, which could prevent the operator from being able to accurately see the location of the tool in the patent’s brain.

In such a case, the neurosurgeon could potentially insert the surgical tool too deeply and damage the patient’s healthy tissue, brain or blood vessels, the FDA wrote in its notice.

The recall includes a total of 5,487 systems with both Synergy and Stealth Station S7 cranial software, according to the FDA notice. It affects software systems with model number 9733763 and software versions 2.2.0, 2.2.5, 2.2.6 and 2.2.7 and model number 9735585 and software versions 3.0.0, 3.0.1 and 3.1.0, and is limited to systems manufactured and distributed between August 31, 2011 and October 16, 2018.

Medtronic began notifying individuals about the recall on September 21 last year, and provided steps to mitigate or eliminate risk of damage to healthy tissue during use.

The company advised operators to not set a projection longer than the length of the surgical plan, to follow the cranial software pocket guide and always use the biopsy needle mechanical depth stop and to ensure the navigation instrument tip setting is selected prior to locking trajectory and beginning navigation.

Last month, Medtronic said that it closed the $1.7 billion acquisition of Mazor Robotics (NSDQ:MZOR) and its robot-assisted surgery platform, capping the buyout with the announcement that their first jointly produced product won an FDA nod.

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Zoll Medical acquires Payor Logic

Zoll, Payor Logic

Zoll Medical said today that it acquired healthcare software solution developer Payor Logic for an undisclosed amount.

Centerville, Ohio-based Payor Logic develops and supports accounts receivable software solutions specifically for the healthcare industry. The solutions are intended for use by emergency medical services, emergency physicians, DME providers, hospitals and labs, Zoll said.

“In today’s environment, healthcare organizations must consider the bottom line across their operations. We’ve always delivered better efficiencies to our customers, but with Payor Logic technology, our customers will see unprecedented improvement on their bottom line. Some customers have increased total payments by over 110 percent, and improved claim processing throughput by 88 percent. With this acquisition, Zoll can bring that level of A/R efficiency to hundreds of organizations across the healthcare spectrum, offering better financial performance, freeing up capital to reinvest in their operations and ultimately providing better patient care,” Zoll data systems prez Alex Moghadam said in prepared remarks.

Payor Logic has worked with Chelmsford, Mass.-based Zoll since 2015, the companies said, providing its services as part of Zoll’s Billing Pro solution.

“Payor Logic has always been recognized for our ability to increase reimbursements for healthcare providers, most of whom can’t afford to leave any revenue on the table. Our innovative solutions are truly unique, and we are pleased to join Zoll and leverage their reach and strategic vision to deliver these benefits to a wider segment of the market,” Payor Logic founding partner Ted Williams said in a press release.

Last summer, Zoll Medical said that it won more than $5 million with an arbitrator’s decision in its spat with former partner AutoMedx.

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FDA chief details next steps for digital health pre-cert pilot

FDA-logo-newFDA chief Dr. Scott Gottlieb announced today the next steps for his agency’s digital health pre-certification pilot program.

“Digital tools are rapidly evolving, and to keep pace with this promising innovation, the FDA must modernize its approach to regulation,” he said in a statement.

The program, which launched in October of 2017, was designed to streamline the review of digital health products by appraising developers and giving them the chance to participate in a more tailored premarket submission process.

Today, the agency issued three documents to kick off the next phase of the FDA’s pre-cert model.

The first was an outline describing how the FDA plans to use its de novo submission pathway in the pre-cert model. Device-makers that submit their application via the de novo pathway have to meet certain quality system regulation requirements, including software design control and validation and good manufacturing practices – it’s not unlike the information collected during the “Excellence Appraisal” part of the pre-cert process, the FDA noted.

“By collecting this information early, the Excellence Appraisal could be leveraged to streamline a developer’s De Novo submission, reducing content the developer would need to submit to the agency under the De Novo pathway since the information would already have been demonstrated and documented during the Excellence Appraisal. This allows the FDA to tailor the premarket submission content to the unique considerations related to each particular digital health device and enables more efficient evaluation of low-risk digital health devices,” Gottlieb explained.

The second item released by the FDA was a test plan for 2019. This year, the agency plans to test how the pre-cert program (using the streamlined de novo pathway) compares to the traditional regulatory pathway in reference to safety and efficacy measures. To do so, the FDA said it will review sponsors’ traditional de novo submissions and, in parallel, review the sponsors’ Excellence Appraisal information with the proposed streamlined submission content.

Finally, the FDA published an update to its Working Model to clarify how the pre-cert pilot works now and how the agency wants it to work in the future.

“In this third draft of the Working Model, the public will see how we’ve incorporated into the model the extensive feedback received and we look forward to additional engagement on this version and the other documents released today,” Gottlieb said. “Our new actions will promote the development of novel, beneficial technology while ensuring that patients have access to high quality, safe and effective digital health devices.”

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CES 2019: Medical technologies you need to know

CES-2019Mobile health devices and wearables are increasingly playing a prominent role at the annual CES show in Las Vegas, with 505 digital health and 620 wearables exhibitors at this year’s show.

Health and medical devices touted at CES 2019 – Jan. 8–11 – were meant to improve everything from posture to sleep analysis. Time will tell which companies and technologies pan out.

Here are nine companies exhibiting digital health products at this year’s show.

Next >>

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Korean JLK Inspection launches AI-powered imaging diag system

JLK Inspection

Korean JLK Inspection said yesterday that it launched its AIHub artificial intelligence-powered medical image diagnostics platform.

The newly launched AIHub system is designed to analyze images from a number of different imaging modalities, including magnetic resonance imaging, computed tomography, X-ray and mammography, the Seoul-based company said.

JLK Inspection claims the system can detect and monitor for more than 30 medical conditions in 14 regions of the body. The company added that the system is focused on brain diseases and conditions including ischemic stroke, hemorrhagic stroke, brain aneurysm and Alzheimer’s disease, as well as lung cancer, prostate cancer, breast cancer, coronary artery disease and other digital pathology.

“We are excited to show how we are able to assist users with quantitative analysis of their medical images at their own convenience. The ability to provide optimal diagnosis support based on deep learning technologies, unique algorithms and imaging procession techniques will be a great benefit to all patients, whether suffering from minor or major ailments,” CEO Won Tae Kim said in a press release.

JLK Inspection said that it has raised over $17 million so far in venture capital funding, and that it is planning an initial public offering in Korea some time during the second half of next year.

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IoT-device focused cybersecurity group Cybeats raises $3m


Cybersecurity company Cybeats said last week that it raised $3 million to support its services which focus on protecting Internet of Things device, including medical devices.

Funding from the round will support expanding sales, research & development and expanding its enterprise capabilities with a focus on medical devices, smart buildings and critical infrastructure, the Toronto-based company said.

As part of the funding round, Ripple Ventures managing partner Matt Cohen and GreenSoil Building Innovation Fund managing partner Susan McArthur have joined the company’s board of directors, Cybeats said.

“Efficient, reliable cyber security solutions are essential in order to leverage the full potential of digital built environment. Cybeats’ technology is providing real time cybersecurity solutions to IoT device manufacturers and users,” McArthur said in a prepared release.

“Ripple Ventures is extremely excited to be leading this investment in Cybeats as they help detect and prevent more cyber attacks from occurring. The Cybeats team is among the most experienced and knowledgeable cybersecurity experts we have encountered. We look forward to working closely with Cybeats as they expand their solutions globally,” Cohen said in prepared remarks

CyBeats said it uses internal defense, monitoring and lifecycle management to protect IoT devices against existing and new cybersecurity threats.

“With the proliferation of IoT devices where we work, live, travel and shop, and increase in the number of access points prone to malware attacks, it is critical that we adopt a new approach to cybersecurity for all network-connected devices. The security certification of IoT devices is imperative in order to detect and neutralize these growing threats. Cybeats provides an efficient, simple solution to monitor and overcome security threats,” co-founder & CEO Dmitry Raidman said in a press release.

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ResMed’s Brightree picks up Apacheta

ResMed's Brightree acquires ApachetaResMed (NYSE:RMD) subsidiary Brightree said this week that it paid an undisclosed amount to bolster its software-as-a-service holdings with Apacheta.

Media, Pa.-based Apacheta makes mobile apps that allow companies to automate and streamline business processes in sales, marketing, logistics and field services.

“Apacheta solves many of the business challenges [home medical equipment companies] face in managing deliveries, particularly eliminating missing, lost or incomplete delivery information,” Brightree CEO Matt Mellott said in prepared remarks. “It has already helped Brightree customers save significant time and money, and we look forward to investing in its continued innovation and scalability.”

“We’re thrilled to become part of a healthcare leader that shares our mission: leveraging technology to digitally transform field service management and delivery functions providing quantifiable business efficiencies, better customer care, and improved visibility to logistics practices,” added Apacheta CEO Gregg Timmons. “The HME business is becoming more and more challenging, and like Apacheta, Brightree offers software solutions that eliminate complexity in order to increase productivity.”

ResMed has been on an M&A tear since buying Brightree for $800 million in April 2016. In May of this year it inked a deal to acquire healthcare software developer HealthcareFirst for an undisclosed amount; last month it closed the $750 million acquisition of MatrixCare and its post-acute-care software; and earlier this month ResMed put $225 million on the table for Propeller Health and its digital medicine platform.

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