FDA lays out postmarket medical device cybersecurity recs in final guidance.

As our world becomes more interconnected, so do our medical devices: we are connecting devices such as insulin pumps and glucose meters to apps, some of which also have cloud connectivity, enabling patients to share their health data with caregivers and loved ones. But this increased interconnectivity comes with vulnerability to cybersecurity threats.

The FDA published its final guidance on the postmarket management of cybersecurity in medical devices last week. The recommendations apply to medical devices that use software, including programmable logic and software that is regulated as a medical device, including mobile medical apps. The document follows the agency’s final guidance on premarket cybersecurity for medical devices issued in 2014.

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Takeda teams up with Koneksa to integrate remote data capture into clinical trials

Takeda is enlisting data integration player Koneksa Health on a scheme to bring new digital health tools to its clinical trials. The partnership will see Takeda using Koneksa’s remote data collection capabilities in trials for multiple pipeline candidates.

The goal of the tie-up is to develop “digital biomarkers” that could support decision-making and eventually contribute to new endpoints that will improve the assessment of patients in their natural environment, according to a statement.

The Japanese pharma will use Koneksa’s platform to integrate biosensors and wearables in a number of early-stage clinical trials, according to the statement. The technology facilitates the collection of patient-generated data that were previously tricky to obtain, such as patients’ continuous vital signs, activity levels and sleep metrics, Takeda said.

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Owlet grabs $15M to advance infant breathing monitor and app

Owlet Baby Care just boosted its total capital raised to $25 million, thanks to a new $15 million in venture financing and an NIH grant. The new infusion will drive the international distribution efforts of its baby monitor that alerts parents via smartphone app if their baby stops breathing.

The Owlet baby monitor comprises a sensor-embedded smart sock, a base station and a smartphone app. The smart sock monitors the infant’s heart rate and oxygen levels using pulse oximetry and communicates this data to the base station via bluetooth. If the child’s heart rate is too low or too high, or if his or her oxygen level falls below a preset threshold, the base station and smartphone app will sound an alert. In 2017, the company expects to launch a feature allowing users more access to these data as well as the ability to share it with pediatricians, according to a statement.

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Study: 'Vocal biomarkers' can predict likelihood of heart disease

Voice analysis specialist Beyond Verbal and Mayo Clinic unveiled results from a new study demonstrating a strong correlation between some voice characteristics and the presence of coronary artery disease (CAD).

Beyond Verbal, which bills itself as an emotions analytics company, focuses on extracting as much information as possible from the tone of voice of a speaker, said CEO Yuval Mor. Voice analysis may be used to understand emotions and well-being, he said. We can tell with the human ear, for example, if a person is feeling well or not. The new study data confirms that we can also understand a medical condition by using voice feature analysis.

The double-blind study involved 120 patients who had been referred for elective coronary angiography and 120 control patients. Beyond Verbal provided Mayo Clinic with acoustic features, and the latter zeroed in on some characteristics that could “strongly and independently” be associated with CAD, Mor said. In particular, one feature was linked to a 19-fold higher likelihood of CAD, the companies said in a statement.

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With FDA nod, Philips adds cardiac imaging to smartphone plug-in ultrasound device

The FDA cleared Philips’ cardiac transducer for use with Lumify, the company’s smart-device diagnostic ultrasound. The new add-on brings cardiac imaging to the portable diagnostic, which already allows doctors to scan the gallbladder and lungs among other areas.

Launched a year ago, the Lumify package consists of an app and two transducers for use with an Android smartphone, as well as access to an online portal and Philips support. The app connects to the cloud, where clinicians may access data and images through Philips’ HealthSuite Digital Platform. In addition to cardiac and abdominal scanning, Lumify also offers OB/GYN and focused assessment with sonography for trauma (FAST) examinations.

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Study: Veteran caregivers use apps to access EHRs, fill prescriptions

Caregivers for military veterans prefer mobile health apps that give them access to their loved one's electronic healthcare record and allow them to do tasks like refill prescriptions and set medication reminders, according to a report published in the Journal of Medical Internet Research.

The 882 caregivers participating were had been enrolled in the Department of Veterans Affairs's Comprehensive Assistance for Family Caregivers program and also participated in the VA Family Caregiver Mobile Health Pilot program.

The researchers found that caregivers living in rural areas were more likely to use the apps, as were caregivers of veterans who have a mental health diagnosis like post-traumatic stress disorder (PSTD). Use of the apps also was much greater if the caregiver of the veteran was a spouse, the researchers found.

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App that evaluates child development as good as standard model

A smartphone app version of the standard Parents Evaluation Developmental Status works just as well as the traditional tool used by community health workers, according to a recent study.

The digital PEDS tool is a near perfect option of today’s paper-based approach, according to the Telemedicine and eHealth report, and may foster more assessments in high-risk communities and grow early teleintervention services in underserved communities.

“This makes early detection of developmental delays in underserved communities possible toward preventative measures and early initiation of necessary interventions,” according to the study's authors, who add that community screening results can be shared with a telehealth framework and provide functionality regarding informational counselling, appointments and reminders.

 

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Researchers: Tablet-based stroke assessments as reliable as in-person efforts

Using tablets for telestroke is proving to be reliable for enabling National Institutes of Health Stroke Scale assessments to be conducted in remote exams, according to researchers.

A new study published in Neurology reveals that the use of tablets for conducting NIHSS assessments was essentially equivalent performing such assessments at the bedside. The study included pilots in central Virginia and the San Francisco Bay area with 27 ambulance runs at both sites.

“Utilizing a low-cost, tablet-based platform and commercial cellular networks, we can reliably perform prehospital neurologic assessments in both rural and urban settings,” the authors of the Neurology study conclude.

The tablet system developed is bidirectional videoconferencing and uses 4G LTE broadband. It puts ambulatory medical teams in real-time communication with a neurologist during the stroke assessment.

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Microneedle can monitor drugs in bloodstream without pain or blood draws

Researchers at the University of British Columbia and Switzerland’s Paul Scherrer Institut have come up with a microneedle that can painlessly measure drugs in a patient’s bloodstream without requiring expensive and invasive blood draws.

The device is a small, thin patch that is pressed against a patient’s arm during medical treatment. Its minute, needle-like projection measures less than half a millimeter long and doesn’t penetrate the skin like a standard hypodermic needle.

The microneedle is designed to puncture the outer layer of skin, but not the next layers of epidermis and the dermis, which house nerves, blood vessels and active immune cells.

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New Apple Watch OS debuts emergency call, medical ID functions

When Apple started working on a smartwatch, it envisioned a device that could monitor blood pressure, heart rate and stress levels, but those functions turned out to be too complex. Now, as the company launches the third iteration of its smartwatch operating system, it's still looking at medical applications, but ones that don't land the device under unwanted regulator oversight.

The new SOS function allows the user to make a call to emergency services by holding down the side button, Lynch said in the presentation. The call will be made through the user's connected iPhone or directly through the watch if it's connected to wi-fi. Whichever country the user might be in, the watch will know the appropriate number to call. Once the call is complete, the watch will then send a message to the user's emergency contacts along with a map of his or her location.

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U.K.'s Owlstone wins $7M for cancer-detecting breathalyzer

Owlstone Medical has raised £4.9 million ($7 million) to fund the ongoing clinical trials of its diagnostic breathalyzer for lung and colon cancers.

While the funding will go toward testing the device in cancer indications, Owlstone is developing the breathalyzer for clinical diagnostic use in inflammatory and infectious diseases as well.

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Bioelectronic device improves rheumatoid arthritis symptoms in first-in-human trial

A trio of collaborators announced Monday clinical trial data showing that an implantable neuromodulation device improved symptoms of rheumatoid arthritis. The results may also have an impact on patients with other inflammatory diseases, such as Parkinson’s, Alzheimer’s and Crohn’s disease.

The Feinstein Institute, Academic Medical Center/University of Amsterdam and GSK-backed bioelectronics player SetPoint Medical announced the results, which were published in Proceedings of the National Academy of Sciences. It is the first study to examine the effect of stimulating the inflammatory reflex in humans. It involved 17 patients with active rheumatoid arthritis (RA), several of whom had previously failed multiple therapies, the partners said in a statement.

Patients had a stimulation device surgically implanted on the vagus nerve, which was then switched on and off according to a set schedule. Patient response was measured over 84 days and primary endpoints recorded at day 42 using a standard disease activity composite score that takes into account number of swollen and tender joints, patient and physician assessment of disease activity and serum C-reactive protein (CRP) levels.

The results show that stimulating the vagus nerve blocks the production of TNF, one of several cytokines involved in rheumatoid arthritis, the statement said. No serious adverse events were reported.

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MIT team creates wearable nanotube toxic gas detectors

MIT researchers have developed a lightweight toxic gas detector for use with a smartphone, which could potentially help protect soldiers from chemical weapons as well as protect people who work with hazardous chemicals.

The device is sensitive enough to detect less than 10 parts per million of toxic gases within 5 seconds. It is a circuit with carbon nanotubes surrounded by an insulating polymer. The polymer wraps around each of the tens of thousands of nanotubes that make up the device, which separates them, making them resistant to electricity. When the device is exposed to electrophilic, or electron-loving, substances, the polymer breaks down, allowing the nanotubes to join together and increase conductivity. After the electrical resistance goes below a certain level, a near-field communication turns on, sending signals that are detectable by mobile devices with NFC technology.

Electrophilic substances include certain chemicals used in choking agents and nerve gas.

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Apps, computer games gaining traction as weight loss tools

Research on how technology-based behavioral training can impact eating decisions is spurring deeper study involving an app and a computer game aimed at reducing sugary foods intake and boosting weight loss.

The researchers of the study, published at ScienceDirect, found that computerized inhibitory control training (ICT) and mindful decision-making training (MDT) can stem junk food intake and boost better eating decisions. The study involved 119 salty snack food eaters using a smartphone-based ecological momentary assessment system.

“These results provide qualified support for the efficacy of both types of training for decreasing hedonically-motivated eating. Future research should investigate the additive benefit of de-atomization training to standard weight loss interventions,” the study's authors write.

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Early trial shows wearable artificial kidney could be viable alternative to haemodialysis

While haemodialysis has improved since its introduction in the 1960s, there are still some drawbacks, most notably being tethered to a machine for several hours, multiple times a week. The University of Washington Medical Center in Seattle has tested a wearable artificial kidney (WAK) that could give patients more freedom while dialyzing.

The WAK comprises miniaturized dialyzer components worn around the waist like a tool belt. It is connected to patients by a catheter, according to a University of Washington article. The data from the 7-patient safety and efficacy trial were published last week in JCI Insight.

No serious adverse events were recorded and the device effectively cleared the patients' blood of waste, such as urea, creatinine and phosphorus, as well as excess water and salt. It also regulated body fluid volume and composition the way a real kidney would.

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Devices first approved in EU more likely to encounter safety issues

While the U.S. typically lags the European Union in medical device approval rate, a new study shows that devices first approved in the EU are linked to a greater risk of post-marketing safety alerts and recalls.

The researchers studied the publication of trial outcomes and safety alert and recall information for novel cardiovascular, orthopedic and neurologic devices that received a CE mark between 2005 and 2010. The majority of such devices were approved first in the EU and then in the U.S. The findings were published Tuesday in The BMJ.

They looked at a total of 309 devices, 206 (or 67%) of which were approved in both markets. Of these, 63% were approved first in the EU. While approximately one-quarter of the total devices studied were associated with safety problems after commercialization, those approved first in the EU--including products yet to receive U.S. approval--had a higher rate of safety alerts and recalls than those approved first in the U.S. The unadjusted rate for these safety issues was 27% (62 out of 232) for devices first approved in the EU compared with 14% (11 out of 77) for those approved in the U.S.

Companies typically seek a CE mark before FDA approval, as high-risk devices are approved more quickly in the EU than in the U.S. Devices can be marketed in the EU if they work “as intended" and clinical testing may only be required for certain high-risk devices. Meanwhile, in the U.S., high-risk devices must undergo safety and efficacy clinical trials before they are allowed for use in patients. As a result, patients in the U.S. may wait up to three additional years for access to devices that are approved in the EU, the researchers wrote.

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Philips launches at-home senior care sensor system, wins VA grant for next-gen assisted living

Royal Philips has started a beta launch of a new Internet of Things (IoT), remote care service with partner Right at Home, a major in-home senior care network. Dubbed CareSensus, it uses connected sensors and analytics to monitor everyday behaviors such as sleeping, movement, eating and trips to the bathroom to identify changes in patterns that suggest the need for alterations in care.

The project is an early step toward usefully integrating technology into improving and enabling at-home care. Philips is also working at the outer edges of imagining what this technology could look like decades from now. It just got a grant from the Department of Veterans Affairs to research Ambient Assisted Living technology that integrates sensors, actuators, interfaces, and artificial intelligence for use at home to support those with mild cognitive impairment (MCI).

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Slack - A service built for the era of mobile phones and short text messages is changing the workplace.

The intra-office messaging system known as Slack is often described as the fastest-growing workplace software the world has ever seen. It surpassed two million daily users less than three years after its launch in 2013. Slack gives you a centralized place to communicate with your colleagues through instant messages and in chat rooms, which can reduce the time you have to spend on e-mail.

The reason for its success lies in part with big trends: more and more people now get work done on mobile devices, in collaboration with people who aren’t always in the same office at the same time. But Slack’s specific design choices have also been important. Gerald C. Kane, associate professor of information systems at Boston College’s Carroll School of Management, points out that Slack funnels messages into streams that everyone who works together can see. That “allows you to ‘overhear’ what is going on in an organization, which research has shown can lead to business impact,” he says. “It’s a kind of ambient awareness that you just don’t get from e-mail.”

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Monitoring improves sleep apnea device compliance: Kaiser study

A study from Kaiser Permanente found that remote monitoring and automated coaching using ResMed can significantly improve continuous positive airway pressure therapy compliance for patients suffering from obstructive sleep apnea. The findings were recently presented at the SLEEP conference in Denver.

More than 1,400 people on CPAP therapy took part in the study. Out of that randomized selection, 556 were prescribed AirSense 10 CPAP machines that featured built-in cellular communications. Breaking that group down even more, 129 were placed in a typical care arm, 164 into the telehealth education arm, 125 into CPAP monitoring through U-Sleep and the final 138 into a telehealth education and CPAP monitoring arm.

Those who used U-Sleep support achieved Medicare-defined CPAP adherence 21% more than the average study participant over 90 days. Even more, those working with web-based education alone did not see a "statistically significant impact" on CPAP usage over three months.

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Stanford, Intermountain start consortium to use genomic data to better match patients to clinical trials

Stanford Cancer Institute, Intermountain Healthcare, Providence Health & Services and Syapse have joined forces to create a consortium to advance cancer care via data sharing and increase access to clinical trials.

Dubbed the Oncology Precision Network (OPN), the consortium will share aggregated cancer genomic data through an advanced software platform in order to bring promising treatment insights to patients and physicians.

"The highest quality cancer care is predicated on clinical trial participation and currently very few cancer patients can access trials that are matched based on the genetic make-up of their cancer," said Dr. Thomas Brown, executive director of the Swedish Cancer Institute and co-chair Providence Health & Services Personalized Medicine Program. "This partnership will further our efforts to provide customized therapies that are based on the biological features of both the patient and their unique cancer."

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