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Meddevicetracker Weekly Roundup

February 5-9, 2018


February 5, 2018



Amiko Receives CE Mark for Three Novel Inhaler Sensors


Amiko Digital Health announced that the company received CE Mark for use of the Respiro platform with Teva’s Spiromax inhaler, Chiesi’s Nexthaler inhaler and GlaxoSmithKline’s Ellipta inhaler

Respiro’s medication sensors capture data on true adherence behaviour, which better reflects real-life patient inhaler use, as compared to traditional measures of adherence. Respiro offers advanced inhaler sensors and connected health tools, enabling real-time monitoring of medication use and patient health. At the core of the platform is Respiro Sense, the technology that powers inhaler sensors. Combined with inhalers for asthma, COPD, and CF, the sensors automatically capture data on the patient’s inhalation profiles to monitor when and how well patients use their medication. 

The CE mark shows that Amiko has complied with The European Medical Device Directive 93/42/EEC regarding medical devices. In addition to receiving the CE Mark, Amiko has also received ISO 13485:2016 certification, an international standard governing the requirements of a quality-management system for medical devices and related services. With its ISO 13485:2016 Certification and CE Mark, Amiko is expected to begin the commercialization of the Respiro Platform into Europe in 2018.

See more about Respiro, Spiromax, Nexhaler, and Ellipta on Meddevicetracker.


PolarityTE Provides Updates on the Clinical Use of SkinTE


PolarityTE announced that initial results from the clinical applications of the commercially launched SkinTE are yielding outcomes that are correlative with the Company’s preclinical research, announced in January 2018 in the company's Annual Report on Form 10-K, which resulted in regenerative healing of full-thickness hair-bearing skin, including all layers (epidermis, dermis, and hypodermis) and glands. 

The first group of patients treated with SkinTE are currently at an interim stage of healing and regeneration and the Company expects final results from the initial clinical applications of SkinTE to be available in the first half of 2018, with peer-reviewed publications to follow. 

SkinTE has now been used at multiple medical facilities to treat the entire spectrum of wounds, including: chronic wounds, surgical wounds, reconstructive wounds, acute burns, and the replacement of scarred and contracted skin grafts with SkinTE. The initial scale-up of manufacturing operations is nearly complete, facilitating capacity to respond to ongoing demand. The Company also expects to release additional preclinical data from its OsteoTE bone regeneration development program in the first quarter of 2018. 

See more about SkinTE on Meddevicetracker.


12th Virtual Reality Patent Granted to SyncThink


SyncThink announced the granting of patent US 14/530,598 by the U.S. Patent and Trademark Office. This patent allows SyncThink to use systems and methods for creating and changing dynamic content based on eye gaze analysis. The patent gives SyncThink options to broaden the application of its core technology, especially in the growing arena of virtual reality. This will be SyncThink’s 12th granted patent. 

SyncThink currently maintains 11 additional patents in the eye tracking analytics and the VR hardware field, ranging from a training system and method for improving cognition and motor timing, to eye tracking headset and system for visual impairment testing in the assessment of brain health. 

SyncThink plans to use its proprietary eye tracking metrics to identify and analyze the attention gaze of the user and will modify the viewing content instantaneously based on the eye analytics. This may be used for training, performance optimization, and understanding how users view and utilize content in VR most effectively.


See more about EYE-SYNC on Meddevicetracker.


February 6, 2018



BioVentrix’s Revivent TC System Achieves 2018 Reimbursement in Germany


BioVentrix announced that InEK, the German Institute for the Hospital Remuneration System, has reconfirmed the award of NUB Status 1 for the company's Revivent TC transcatheter ventricular enhancement system. The company first received German Reimbursement from InEK in February 2017.

The company stated that the NUB process recognizes select innovative medical devices for reimbursement support in Germany. It enables participating hospitals to receive full reimbursement for the product and a supplemental payment when utilizing groundbreaking technologies not listed in the existing German health care system. Revivent TC achieved this status for the second consecutive year, noted BioVentrix.

Revivent TC is intended for the treatment of heart failure patients who have limited options available to treat their left ventricular dysfunction. 

The company received CE mark approval in 2016 for the Revivent TC system for plication of scar tissue in postmyocardial infarction ischemic cardiomyopathy patients. The Revivent TC System is approved for sale in Europe. The device is not approved for sale in the United States. 

According to BioVentrix, placement of the Revivent TC System is performed via the less invasive ventricular enhancement (LIVE) procedure. In the LIVE procedure, small titanium anchors are placed along the outer surface of the heart and along one of the interior walls via a catheter-based approach. The anchors are then pulled toward one another, effectively excluding the scarred and nonfunctioning heart wall.

See more about the Revivent System on Meddevicetracker.


Allurion Technologies Initiates Pivotal U.S. Clinical Trial for the Elipse Balloon


Allurion Technologies announced the start of ENLIGHTEN, a United States clinical trial for the Elipse Balloon, a procedure-less gastric balloon for weight loss. Jaime Ponce, M.D., Medical Director of Chattanooga Memorial Hospital Weight Management Center is serving as the principal investigator of the ENLIGHTEN study.

The Elipse Balloon received its European Union CE mark in December 2015 and is currently available in more than 40 weight loss centers in countries across Europe and the Middle East. Unlike other weight loss balloons, the Elipse Balloon is placed and removed without surgery, endoscopy, or anesthesia. It is swallowed in a capsule during a brief, outpatient office visit and remains in the stomach for approximately four months, after which it opens and passes naturally from the body.

ENLIGHTEN is a randomized, sham-controlled study designed to evaluate the safety and efficacy of the Elipse Balloon in 400 individuals. The study will be conducted at up to 12 sites in the United States.

See more about the Elipse Gastric Balloon on


Vaccibody Expands Human Clinical Trial of HPV Vaccine


PharmaJet announced that Vaccibody is expanding their human clinical trial (Phase IIa) for the study of a vaccine to treat HPV disease using the PharmaJet Stratis needle-free injection system.

Vaccibody reported clinical trial results in 2017 of their therapeutic DNA vaccine (VB10.16) delivered with PharmaJet’s needle-free injection technology. The trial showed that the vaccine had an acceptable safety profile, and induced an HPV16-specific immune response that has been reported in literature. Recruitment has now been finalized for the Phase IIa human clinical trial.


See more about the PharmaJet Stratis Needle-Free Injector on Meddevicetracker.


As this product is classified as drug delivery technology, the full development history of VB10.16 can be seen on Biomedtracker.


February 7, 2018



Abbott Launches FreeStyle LibreLink App in Europe


Abbott announced that the FreeStyle LibreLink app is now available in Europe for use with compatible smartphones (both iPhone and Android). People with diabetes living in Europe and using the FreeStyle Libre System are now able to access glucose data directly from their smartphones, eliminating the need to carry the separate FreeStyle Libre Reader (a handheld device used to scan the FreeStyle Libre sensor to get a glucose result). Since 2015, the app offering for the FreeStyle Libre System was only available for Android users, but now the FreeStyle LibreLink app is also compatible with iPhone.

Utilizing their phone's near-field communication (NFC), the FreeStyle LibreLink app enables users to hold their smartphone near their FreeStyle Libre sensor to capture and view their real-time glucose levels, their eight-hour glucose history, and how their glucose is currently changing; and add notes to track food, insulin use, medication and exercise. The FreeStyle LibreLink app is compatible with NFC enabled phones running Android OS 5.0 or higher and with iPhone 7 and later running iOS 11 and later.

Customers using the FreeStyle LibreLink app will have access to several updates and features in comparison to the FreeStyle Libre reader, including:


  • A larger, high-resolution display
  • Text-to-speech capabilities for glucose readings (when enabled)
  • The ability to log smaller doses of insulin (0.1 unit versus 0.5 units)
  • Support for 26 languages

While the app can replace the reader, the two can also be used in combination with each other. FreeStyle LibreLink users also have the option to share their information with their healthcare professional and caregivers through LibreViewand LibreLinkUp, other digital health tools that are also part of the FreeStyle Libre platform:


  • LibreView is a secure, cloud-based diabetes management system that enables the patient to share their glucose insights with their healthcare provider.
  • LibreLinkUp is an app that enables caregivers of people living with diabetes in Europe to remotely monitor their loved ones' glucose readings.

Abbott's FreeStyle LibreLink app is available free of charge for both iPhone and Android, initially in 12 European countries including Austria, Belgium, Finland, France, Germany, Ireland, Italy, Spain, Sweden, Netherlands, Switzerland and the United Kingdom. Abbott is aiming to provide a mobile app solution for FreeStyle Libre users outside of Europe, based on in-country regulatory approvals.

See more about the FreeStyle LibreLink Mobile App on Meddevicetracker.


Smith & Nephew Announces European Launch of New PICO 7 Single Use Negative Pressure Wound Therapy System


Smith & Nephew announced the European launch of the PICO 7 Single Use Negative Pressure Wound Therapy System (sNPWT). It was confirmed that PICO 7 met all relevant European requirements on Wednesday, January 24th, 2018. 

Clinically, the PICO 7 delivers a more efficient vacuum and improved leak management, designed to support application on anatomically challenging areas where it is traditionally more difficult to achieve and maintain a seal. It also includes a dressing-full indicator for sNPWT devices, which is intended to reduce unnecessary dressing changes and wastage. 

For the patient, PICO 7 is quieter than the previous version, making it less intrusive, which can be of particular value when the patient is outside the home or sleeping. There is also a new user interface to simplify patient operation and a belt clip to improve portability. 

PICO 7 is designed for patients at risk of poor healing, and has been shown to help minimize the failures of healing that may lead to infection and/or dehiscence. It is suitable for use in both a hospital and community setting and is approved for a number of indications, including surgically closed incision sites. A recently published meta-analysis demonstrated the efficacy of PICO used prophylactically for SSI reduction in closed surgical incisions compared with standard care.


See more about PICO on Meddevicetracker.


PathMaker Neurosystems Awarded NIH Cooperative Agreement Grant to Develop MyoRegulator for the Non-Invasive Treatment of Spasticity


PathMaker Neurosystems announced that it has been awarded a nearly $5 million cooperative agreement from the National Institutes of Health to advance the development of its non-invasive device, MyoRegulator, as a treatment for spasticity secondary to stroke. The 4-year grant has been awarded through the CREATE Devices program that provides a collaborative partnership with the National Institute of Neurological Disorders and Stroke (NINDS). The collaborative partnership and funding will support product engineering, multi-center U.S. pivotal trials and regulatory submission for MyoRegulator. The CREATE Devices program encourages the pursuit of translational and clinical studies for therapeutic devices to treat neurological disorders.

MyoRegulator is a non-invasive neuromodulation device based on proprietary DoubleStim technology, which provides simultaneous non-invasive stimulation at spinal and peripheral sites to reduce muscle spasticity. MyoRegulator was one of the first medical devices selected for the U.S. Food and Drug Administration’s Expedited Access Pathway and is now in IRB-approved human clinical trials. The multi-center US trials will be coordinated through a subaward to Northwell Health (formerly North Shore-LIJ Health System) and The Feinstein Institute for Medical Research.


See more about the MyoRegulator PM-2200 on Meddevicetracker.


February 8, 2018



DarioHealth Wins Clinical Study Contract


DarioHealth announced it has entered into an agreement with an undisclosed pharmaceutical company conducting a clinical study for a new drug related to managing diabetes. The pharmaceutical company is seeking FDA clearance for this drug and has selected DarioHealth to run and track the blood glucose readings of participants in the clinical study. DarioHealth's business-to-business (B2B) platform aims to increase user engagement during the course of the clinical study and will allow the participants to log their blood glucose monitor (BGM) readings in real-time in the Dario logbook, along with utilizing features such as reminders and statistics.

See more about the Dario Smart Meter on Meddevicetracker.


Global Investors Back Rani Therapeutics with $53 Million as Company Moves to Clinical Trials


Rani Therapeutics announced that it has raised $53 million to invest in manufacturing in preparation for human clinical trials. This investment brings the total raised to $142 million in funding.

New investors include GeneScience Pharmaceuticals, Shire, Bossa Ventures, and Cathay Venture. They join GV, the investment arm of Alphabet, Novartis, AstraZeneca, Ping An Ventures, Virtus Ventures, among others who have previously invested in the company.

To further support the move to clinical trials, Rani has brought on Ray Diradoorian, former global head of manufacturing for Allergan, as a consultant, and has hired Wilfredo Ortiz to lead day-to-day manufacturing operations. In addition to bolstering the internal team, Rani is working with a manufacturing automation company to help develop the aseptic manufacturing line needed for human testing.

See more about the Rani Pill on Meddevicetracker.


February 9, 2018



Novo Nordisk’s Ozempic Approved in the EU for the Treatment of Type II Diabetes


Novo Nordisk announced that the European Commission (EC) has granted marketing authorisation for Ozempic (semaglutide) for the treatment of adults with type II diabetes. Ozempic is a new once-weekly analogue of human glucagon-like peptide-1 (GLP-1) indicated as monotherapy when metformin is considered inappropriate due to intolerance or is contraindicated, and as an addition to other medicinal products for the treatment of diabetes. The marketing authorisation applies to all 28 European Union member states.

The label reflects the superior and sustained reductions in HbA1c and body weight achieved with Ozempic relative to comparator treatments, cardiovascular benefits and the statistically significant reduction in diabetic nephropathy with Ozempic relative to standard of care.

Ozempic has been approved in the EU for use in a multi-dose Ozempic pen, the latest generation of Novo Nordisk prefilled devices. However, Novo Nordisk intends to submit a variation application to the European Medicines Agency (EMA) seeking approval of an updated Ozempic pen offering. The new pen offering will help facilitate reimbursement for patients with type II diabetes using Ozempic. The launch of Ozempic is expected to take place in the first EU countries in the second half of 2018 following the approval of the variation application for the updated pen offering.

See more about the Ozempic Pre-Filled Pen on Meddevicetracker.

As this product is classified as drug delivery technology, the full development history of Ozempic can be seen on Biomedtracker.

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