SuperSonic Imagine wins Japanese clearance for Aixplorer

SuperSonic Imagine said today said it won regulatory approval in Japan for its most recent Aixplorer ultrasound system, which includes new features that allow for the evaluation of liver disease, prostate cancer, obstetrics and musculoskeletal assessment.

A new line of ultrasound probes were included in the approval, as well as the company’s Anigo Planewave UltraSensitive microvascular visualization program.

The Angio P.L.U.S. system is designed to provide improved microvascular imaging through increased color sensitivity and spatial resolutions, as well as increases in the detail of real-time flow information available during ultrasound diagnostic exams, the company said.

“We are pleased to have received approval for the latest innovations on Aixplorer, our ultrasound system that has been widely adopted throughout Japan with the help of our partner Konica Minolta. Japan is the third largest ultrasound market in the world, therefore securing approval for these advanced technologies is critical milestone for our continued success,” chief innovation officer Jacques Souquet said in a press release.

In March, SuperSonic Imagine said it inked a U.S. distribution deal with Sandhill Scientific to distribute its Aixplorer ShearWave Elastography-equipped ultrasound system designed to assess liver disease, along with releasing its 2015 earnings.

Through the agreement, Sandhill will have rights to sell the Aixplorer ultrasound system to gastroenterologists and hepatologists from March 14, while SuperSonic Imagine will keep its direct sales force targeted on radiology, breast and other clinical segments, the company said.

The company also announced its 2015 earnings, seeing losses grow faster than revenue for the year compared to 2014. SuperSonic Imagine reported losses of $14 million (EU €12.7 million) on sales of $24 million (EU €21.7 million) for the year..

That amounts to a 14.9% growth in losses as sales grew only 0.6% compared with 2014.

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Centerline Biomedical wraps up pre-clinical study, looks to Series A

Interventional vascular device-focused Centerline Biomedical said today it completed its 1st pre-clinical study evaluating its IOPS endovascular navigation technology and is looking towards a Series-A round of financing to support the device.

The system, based on research from the Cleveland Clinic’s Heart & Vascular Institute, is designed to aid surgeons navigating endovascular aneurism repair procedures, with plans to expand to a variety of different vascular procedures, the Cleveland, Ohio-based company said.

“We are excited about reaching this important milestone as we launch our campaign for Series-A financing. This study is an important step in taking us to our goal of FDA regulatory submission, with market entry targeted in the third quarter of 2017,” prez Dr. Vinod Goel said in prepared remarks.

Data from the pre-clinical study indicated that the system operated as a “precise 3D ‘GPS-like’ tool” for navigation without the necessity of radiation associated with X-ray fluoroscopy.

The company reported that catheters and guidewires were easily visualized on the IOPS display to allow for accurate navigation through arteries.

“Preclinical evaluation of the IOPS system verified the ability to use this navigation system in manipulating through the aorta and its branches in the absence of radiation-inducing fluoroscopy. This will be a game-changer in the era of endovascular therapy,” study lead Dr. Matthew Eagleton of the Cleveland Clinic said in a press release.

The device will reduce the amount of radiation exposure needed during surgery, normally used to guide devices into positions, Centerline said. The Centerline system is completely radiation-free, the company added.

“This highly innovative IOPS technology has the global potential to impact positively the lives of a large number of patients and caregivers alike,” CEO Dr. Jai Gupta said in a prepared statement.

Last August, Centerline Biomedical said it closed a $1.7 million seed investment round of financing to support its vascular surgical navigation system.

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TransMedics closes $51.2m round to support its Organ Care System

TransMedics said today it closed a $51.2 million round of equity financing to support its Organ Care System organ preservation device.

The company’s flagship Organ Care System is designed to perfuse donor organs with warm, oxygenated blood and monitor its status until transplantation.

“We are thankful and excited to be supported by a world-class syndicate of new and existing life science investors. This financing strongly positions TransMedics to capitalize on the significant market opportunity in front of us,” CEO Dr. Waleed Hassanein said in a press release.

The round was co-led by the Fayerweather Fund and Pharmstandard International S.A., represented by InBio Ventures, Ervington Investments and BioStar ventures, Transmedics reported.

Existing investors Abrams Capital, Lung Biotechnology PBC, Flagship Ventures and KPCB joined the round. A total of 20 investors joined the round, according to an SEC filing.

In February, TransMedics said it launched a pivotal study of its OCS Liver device, which is designed to keep donated human liver warm and perfused until transplantation.

Andover, Mass.-based TransMedics said the 1st liver transplantation using OCS Liver was performed at Mass. General Hospital by Dr. James Markmann, a lead investigator for the 300-patient OCS Liver Protect trial and chairman of its steering committee.

Last November, the FDA told MassDevice.com that it decided it didn’t need to hold an advisory panel meeting to review the TransMedics heart preservation device. TransMedics is seeking an indication for “a portable, ex vivo organ perfusion system intended to preserve a donor heart in a near-normothermic and beating state from retrieval until the eventual transplantation into a suitable recipient,” according to the FDA.

In July, The Lancet published results from the Proceed II study of 130 heart transplant patients, who were randomized to receiving hearts preserved with the OCS or via cold static storage. The TransMedics device came up non-inferior for the trial’s primary endpoint of 30 day patient and graft survival compared with traditional cold storage (94% vs. 97%).

In a Lancet editorial, the authors pointed out that 5 donor hearts in the Proceed II OCS arm were found unacceptable for transplant and discarded, meaning they were also excluded from the recipient outcome-focused study – which could cut both ways.

“The investigators suggest that the Organ Care System was able to identify pathologically abnormal hearts, and that potential recipients of these hearts were spared exposure to suboptimum organs,” they wrote, noting that the OCS would be considered inferior if the endpoint were adequacy of myocardial protection and donor heart utilization “because hearts that were initially deemed acceptable for transplantation were ultimately not implanted.”

“Importantly, the pathological abnormalities identified in these hearts do not necessarily represent non-viability,” they wrote. “Therefore, if these hearts had been allocated to patients in the cold static storage group, they might well have been transplanted with a successful outcome.”

TransMedics raised $20 million last year for the OCS device.

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Diabetes Tech Society releases cybersecurity standards for connected devices

The Diabetes Technology Society this week released its cybersecurity standards for network-connected smart medical device as cyberattacks and data breaches become more commonplace.

The group released a public platform, called DTSec, which contains performance requirements the group says will improve cybersecurity through “independent expert security evaluation,” according to Healthcare IT News.

Though the tool is targeted towards life-critical devices like insulin pump controllers and continuous glucose monitors, authors of the standard say the standard could be applied to any medical product or component.

“We can’t hope to raise the cybersecurity bar. if we don’t know how to measure its height,” chief security officer David Kleidermacher said, according to Healthcare IT News

Kleidermacher said the tool is designed as a blueprint for “efficient, measurable security for networked electronic products and systems in any industry.” The DTSec platform uses an ISO/IEC 15408 framework to define security requirements on smart devices through the creation of “Protection Profiles” and “Security Targets”.

The Diabetes Technology Society said it will publish the names of products that successfully pass its evaluation process.

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NeuroMetrix launches Quell Health Cloud on Android

NeuroMetrix (NSDQ:NURO) said today it launched its Quell Health Cloud for Google‘s (NSDQ:GOOG) Android device platform.

The newly launched Health Cloud app allows users of Quell devices to set up accounts where data from their devices are automatically backed-up to secure storage.

“We are excited to add Health Cloud capabilities to our Android app. We’ve already collected over 640,000 hours of therapy data and 70,000 nights of sleep data on the Quell Health Cloud. We are starting to see trends related to Quell usage and sleep metrics and are excited about the potential to leverage the insight we gain in future innovations,” CEO Dr. Shai Gozani said in a press release.

The Waltham, Mass.-based company said the service will “eliminate consumer worry” about losing sleep or therapy data and allow them to review the data on multiple devices.

The launch brings the Health Cloud to both Android and Apple (NSDQ:AAPL) iOS devices.

In January, NeuroMetrix said it won regulatory approval in China for its DPNCheck diagnostic test for peripheral neuropathy.

DPNCheck is a point-of-care-test designed to detect diabetic peripheral neuropathy at an early stage to allow for appropriate treatment. NeuroMetrix said that DPN is the most common complication of diabetes, and affects more than 50% of people with diabetes.

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The world of digital health

We are in an era where mobile platforms, such as smartphones, tablets and wearable devices have become a necessity. Mobile applications that run on these platforms provide a variety of entertainment options (games, videos, etc.), allows you to check your electronic mail, and interact with family and friends. Other applications that are being developed are now allowing us to track our health and wellness, and even communicate with healthcare providers, remotely. These types of applications are known as either mobile health applications (mHealth) or mobile medical applications (MMAs).

As more MMAs are being created and utilized today, most developers are unaware if it meets the definition of a “medical device”. The Food and Drug Administration (FDA) issued guidance on MMAs to help clarify which applications are regulated. While technology continues to evolve, the Federal Trade Commission (FTC) also released a new web-based tool for the developers of mHealth applications. The tool was developed by the FTC in conjunction with the FDA, the Department of Health and Human Services’ Office of National Coordinator for Health Information Technology (ONC), and the Office of Civil Rights (OCR).

The interactive tool will ask series of questions about the application, such as the nature, the function, type of data to be collected and the service it will provide to users. Based on the developer’s answers, the tool will provide which federal laws apply. The laws that may apply, includes the FTC Act, the FTC Health Breach Notification Rule, the Health Insurance Portability and Accountability Act (HIPAA), and the Federal, Food, Drug and Cosmetics Act (FD&C Act).

While we are all excited for the next big thing, that improves health and healthcare, it is important for developers to know if their MMA is regulated and which laws apply in order to assure safety and effectiveness. If you are in the process of developing a new application and you’re unsure which laws apply, the mobile health apps interactive tool can be found here. If you are unsure whether your MMA meets the definition of a “medical device” check out our previous post here to see which categories the FDA may exercise oversight and enforcement.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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Respiratory Motion wins CE Mark for ExSpiron minute ventilation monitor

Respiratory Motion said today it won CE Mark approval in the European Union for its ExSpiron non-invasive patient minute ventilation monitor.

The ExSpiron patient monitor is designed to improve titration of opioids in postanesthesia care units and in general wards, and to alert attendants to respiratory depression in patientsadministered anesthetics during sedation cases, theWaltham, Mass.-based company said.

“Clinicians around the world rely on minute ventilation to make decisions on the respiratory status of patients on mechanical ventilators. ExSpiron is the only medical device able to provide this measurement in a patient monitor, offering immediate insight into a patients’ respiratory status than what is available in the market today. We are excited to bring minute ventilation monitoring to CE countries with the goal of helping clinicians more rapidly detect the onset of respiratory compromise,” CEO Dr. Jenny Freeman said in a press release.

The company said approval was based off data from 5 studies of the device. The ExSpiron was introduced in April at The Deutscher Anesthesia Congress.

“By showing each breath that is taken on a minute ventilation monitor, clinicians can immediately assess a patient’s work of breathing, and identify at-risk patients and provide early detection of low minute ventilation. This can enable my staff to adjust opioid dosing and ensure optimal pain management.”Dr. H.A. Tillmann Hein said in prepared remarks.

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