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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J&J to create new Texas center to develop ‘breakthrough’ med tech

Johnson & Johnson is pulling out all the stops in its efforts to turn around its medical devices business. After a restructuring early this year, the J&J medical device business actually grew--albeit only by 0.7%--to $6.2 billion last quarter.

The pharma's arm that invests in new technology, Johnson & Johnson Innovation (JJI), is doing its bit to try to help encourage the success of those efforts in the long term. It’s creating the new Center for Device Innovation at the Texas Medical Center (TMC) in Houston, which is intended to enable the entire process of creating “breakthrough” medical devices, the company said.

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Sensimed signs Japanese manufacturer to bring diagnostic contact lens into Asia

Swiss contact lens development company Sensimed is joining forces with SEED, a Japanese manufacturer, to bring its FDA-approved Triggerfish glaucoma lens to that country’s market. The companies are devoting 10 million Swiss francs ($10.1 million) to support Japanese registration and further tests.

Sensimed’s Triggerfish is a soft contact lens with an embedded microsensor that captures eye measurements and intraocular pressure over a 24-hour period and relays the data via Bluetooth to related computer software. The technology gained FDA approval in March.

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Newcastle University testing wearable to restore hand, arm function in stroke survivors

Newcastle University is testing a wearable device in partially paralyzed stroke patients to see if it can restore hand and arm function.

The device, about the size of a mobile phone, strengthens connections between the brain and spinal cord by delivering electrical shocks to the arm and making audible clicks, according to a statement. The treatment is delivered via a pad on the arm and an earpiece. The clicks and electrical stimulation are delivered continuously.

"We think that if they wear this for 4 hours a day we will be able to see a permanent improvement in their extensor muscle connections which will help them gain control on their hand,” said Stuart Baker, a professor of movement neuroscience at Newcastle University, in the statement.

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Validic, Sutter Health partner on patient-generated data in federal pilot program

Sutter Health is teaming up with digital health player Validic to investigate the best way to deliver patient-generated health data to caregivers and researchers. Their findings will help shape government policy and determine how industry will treat patient-collected data.

There is a proliferation of wearables, mobile apps and clinical in-home devices that remotely gather patient data. And while this vast volume of data can help patients and physicians manage their conditions and diseases, it still needs a “proven method” delivery into electronic health records, Validic said in a statement.

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FDA launches contest to develop mobile app technology to fight opioid overdose epidemic

The FDA launched a public contest to develop new technologies that can be used with mobile apps to stem the rising epidemic of opioid overdoses in the U.S.

Called the 2016 Naloxone App Competition, the contest is asking people with expertise in tech fields as well as public health advocates and clinical researchers to come up with a mobile phone app that can connect opioid users experiencing an overdose with the nearest location that has the prescription drug naloxone, the antidote for an opioid overdose.

The winner will receive a $40,000 award and may apply for National Institute on Drug Abuse Small Business Innovation Research grants to further develop their concepts and to develop data to evaluate their real-world impact, the FDA said.

“With a dramatic increase in the number of opioid overdose deaths in the U.S., there’s a vital need to harness the power of new technologies to quickly and effectively link individuals experiencing an overdose … with someone who carries and can administer the life-saving medication,” Dr. Robert Califf, the agency’s commissioner, said in a statement.

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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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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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