ViewRay wins FDA nod for MRIdian system soft tissue visualization capabilities


ViewRay (NSDQ:VRAY)  said yesterday that it won FDA 510(k) clearance to offer soft tissue visualization capabilities with its MRIdian system.

The newly cleared features include expanded high-definition visualization and contrast between tissues, diffusion weighted imaging for improved distinguishing between normal and tumor tissues and more detailed, brighter and faster anatomical planar imaging, the Cleveland-based company said.

“Today we announce another significant step forward in our drive to better treat cancer patients and further differentiate MRIdian in the marketplace. Our customers are seeking significant improvements on imaging speed, resolution and brightness. They also demand that we avoid artifacts and distortions that have historically and consistently plagued the field. We believe these innovations hit the mark. We will continue to advance the field of MR Guided Radiation Therapy and expand the application of the MRIdian system,” founder & chief scientific officer James Dempsey said in a press release.

Last August, ViewRay said that it closed a $172.5 million offering with funds slated to support working capital and general corporate purposes.

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Mauna Kea, Cook Medical terminate Cellvizio dev, distro deal

Mauna Kea, Cook Medical

Mauna Kea (ENT:MKEA) said today that it and Cook Medical have mutually decided to terminate their development and distribution agreement.

The deal, originally inked in late 2015, included the development of Mauna Kea’s Cellvizio confocal laser endomicroscopy systems for urologic applications. Paris-based Mauna Kea said that it agreed to develop a private-label version of the Cellvizio with an emphasis on characterizing upper urinary tract urothelial cancer.

“Mauna Kea was understandably excited by the prospect of combining our innovative, confocal laser endomicroscopy technology with an established medical devices and supplies company with global expertise in sales, marketing and medical education in the urology market. Unfortunately, due to the lack of commercial activity to-date, we have decided to terminate the agreement,” Mauna Kea CEO Robert Gershon said in a prepared statement.

Mauna Kea said that while it is disappointed at the lack of commercial progress in the urology market, the company is “encouraged by the significant progress we have made in the areas of product development, clearance and clinical validation” of the Cellvizio tech in the urology market.

“Specifically, there have been 16 publications studying the use of confocal laser endomicroscopy in urology over the last three years. These publications detail the clinical studies observing more than 150 patients, at 10 hospitals and academic institutions around the world and include some of the most prominent thought leaders in urology. In addition to building our level of clinical validation for Cellvizio in the area of urology in recent years, we have also made progress in introducing 3 new FDA-cleared and CE-marked products for cystoscopy, ureteroscopy and prostatectomy including robotic-assisted laparoscopic surgery which we believe reflects a growing appreciation for our differentiated technology among urologists around the world. We look forward to sharing an update on our progress in each of our markets around the world during 2018, as well as our strategic growth priorities for 2019, during our year-end financial results call on March 20, 2019,” CEO Gershon said in a press release.

Cook Medical has not yet officially commented on the termination of the agreement.

In December 2017, Mauna Kea said that it won expanded FDA 510(k) clearance for its Cellvizio confocal laser endomicroscopy platform and its Confocal Miniprobe devices.

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Philips wins FDA nod for DigitalDiagnost C90 digital radiography system


Philips (NYSE:PHG) said yesterday that it won FDA 510(k) clearance for its DigitalDiagnost C90 digital radiography system.

The Amsterdam-based company said that the DigitalDiagnost C90 includes a live camera image displayed directly at the tube head to provide a clear view of the anatomical area being scanned during positioning.

The newly cleared system also incorporates Philips Eleva user interface intended to improve workflows, the company said.

“In today’s world of value-based care, healthcare organizations are investing in imaging solutions that help them achieve the quadruple aim: improved outcomes, enhanced patient experience, increased staff satisfaction and lowered cost of care delivery. With solutions like the DigitalDiagnost C90, Philips is helping radiology departments get one step closer to achieving that ambition through innovation that enables higher quality images, while keeping the patient and staff experience at the forefront,” diagnostic X-ray business leader Daan van Manen said in a press release.

Earlier this month, Philips said that it launched its new Epiq Elite ultrasound system.

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Philips launches Epiq Elite ultrasound system


Philips (NYSE:PHG) said yesterday that it launched its new Epiq Elite ultrasound system.

The newly launched system from the Amsterdam company contains its “latest advances in transducer innovation,” as well as its first solution for vascular assessment and diagnosis.

“Our new portfolio of dedicated systems and solutions based on the EPIQ Elite combines new display technology, innovative transducers, advanced software and enhanced processing power. With one in four stroke cases caused by vascular disease of the carotid artery in the neck, vascular health is a growing concern worldwide. Ultrasound is the ideal imaging technology to help clinicians make a more precise diagnosis, which is why today we’re announcing our first dedicated solution for vascular assessment and diagnosis,” general imaging and women’s healthcare ultrasound biz lead Jeff Cohen said in a press release.

Philips said that the device comes equipped with an xMatrix linear transducer, which produces 3D vascular images to allow clinicians to see into a vessel and evaluate plaque spatial location and composition and view 3D flow data for quickly assessing stenotic conditions.

“Not much has changed in vascular ultrasound until this release of the ultimate ultrasound solution for vascular assessment. The combination of a new transducer and advances in software makes the assessment and diagnosis of vascular conditions through easy to interpret images. There is now a case to be made for ultrasound solutions to be used as a potential alternative to other imaging modalities in the current standard of care,” Muhammad Hasan of the Baptist Hospital of Miami’s Miami Cardiac & Vascular Institute said in prepared remarks.

Late last month, Philips and the American Heart Association announced a partnership aiming to increase sudden cardiac arrest survival rates in densely populated cities around the world.

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Intracardiac ECG tech dev NuVera Medical raises $15m

NuVera MedicalMedtech incubator Shifamed portfolio company NuVera Medical said today it closed a $15 million financing round slated to support its real-time 3D intracardiac echocardiography technology platform.

The round was led by Cormorant Asset Management and joined by the Capital Partnership, Lilly Asia Ventures and other existing shareholders, the Campbell, Calif.-based company said.

“We are pleased to expand our relationship with NuVera Medical and Shifamed. We are confident in the NuVera team’s ability to execute and deliver this important procedural advancement to the cardiology market,” Cormorant Asset Management CEO Bihua Chen said in a press release.

NuVera Medical is developing a platform that provides side-by-side 2D and 4D intracardiac images with a single ICE catheter, the company said.

“The results of our preclinical work to date have been very positive. With these results, we believe that the value proposition of the NuVera technology in electrophysiology and structural heart applications is further demonstrated, and we look forward to advancing the product to the next stage of development,” CEO Todor Jeliaskov said in a prepared statement.

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Here’s how precision medicine could change medical imaging

Siemens Healthineers recently won FDA approval for the Cios Spin, a mobile C-arm that delivers precise 3D images for intraoperative quality assurance. (Photo from Siemens Healthineers)

The business of precision medical imaging is poised to take off in the next few years, according to a new analysis by Frost & Sullivan.

The market research firm’s report, “Growth Opportunities in Precision Medical Imaging, Forecast to 2022,” said new technologies and processes in diagnostic and therapeutic imaging could spur the market to grow from $120 million in 2017 to more than $8 billion by 2027. Technology advances such as clinical decision support software, sensors, 3D printing, and precision analytics capabilities like deep learning and artificial intelligence (AI) will be applied to medical imaging.

A few firms have pulled ahead, and the rest won’t be far behind, the firm predicted.

Get the full story on our sister site, Medical Design & Outsourcing.

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Oxipit wins CE Mark for AI-powered chest imaging suite


Medical imaging tech dev Oxipit said today that it won CE Mark approval in the European Union for its ChestEye radiology imaging suite.

The ChestEye system is designed to provide analysis and preliminary reports for 75 of the most common radiological findings, Oxipit said. The system localizes its findings on a radiograph as a heatmap and generates a standardized preliminary text report containing all radiologically relevant information in a chest X-ray image, the company added.

Oxipit said that the Chest Eye system also features a search engine that look for similar-looking chest X-rays in a given database, allowing physicians to identify retrospective cases with similar radiological appearances.

“The burden on radiologists has been constantly increasing. This has led to decline in quality of service for patients and bottlenecks to access good quality radiological reporting. The CE mark brings us a step closer in helping radiologists to harness the capabilities of deep learning in order to multiply their productivity and provide excellent service around the clock. ChestEye currently covers over 90% of radiological cases presented to radiologists on a daily basis. It aids the specialists to detect hard-to-catch edge cases and offers a second opinion. In addition, the automatic generation of standardized medical reports significantly reduces the workload of a radiologist, allowing more time for radiogram analysis and less for case description. An internal trial showed 30% time saved per patient and reduced error rate by up to 50%, ” Oxipit CEO Gediminas Peksys said in a prepared statement.

The ChestEye system also features a patient prioritization solution, which identifies and prioritizes individuals with potentially urgent needs, the company said. The platform is offered for both on-premise deployment and as a cloud-based software, Oxipit added.

“Most of our research data comes from tertiary level hospitals where complicated cases are analyzed and some individual images present multiple issues. The dataset represents real-life images that a medical institution encounters on a day-to-day basis, allowing our engine to achieve high precision in everyday applications. Radiologists are already bombarded with too many screens and software applications. From the ground up we have built ChestEye to easily integrate into PACS (automatic image input) and RIS (automatic report output) infrastructure of a radiology department. We strongly believe that in addition to diagnostic precision, computer-aided diagnosis solutions should increase radiologist productivity and make their work less tiresome. ChestEye supports DICOM protocol for image exchange and our the team is working to incorporate HL7 and FHIR protocols in the upcoming versions of the product,” Peksys said in a press release.

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Iradimed pulls MRI-safe patient monitor after running afoul of new EU regulations

IradimedIradimed (NSDQ:IRMD) halted sales of its 3880 MRI-compatible vital signs monitor in the European Union, after its CE Mark approval expired last week.

Winter Springs, Fla.-based Iradimed said the Jan. 17 expiration came after its notified body, UL International, reviewed its technical file and found that it ran afoul of new EU clinical evaluation rules.

UL International granted a temporary, six-month EC certificate for products other than the 3880 monitor, “during which time we expect to cure the non-conformity and be permitted to again use the CE Mark on our 3880 patient vital signs monitoring system,” Iradimed said.

“This action is not the result of safety, effectiveness or performance issues,” the company said. “This action does not impact sales of our 3880 patient vital signs monitoring system in the U.S. or in other markets that do not require a CE Mark for importation purposes.”

“Despite the retrospective application of new guidance to our previously cleared 3380 MRI-compatible patient vital signs monitoring system, we are fully cooperating and in direct discussions with UL to agree upon the necessary and proper application of the new guidance. We believe that data collection, documentation and UL’s review of the required information will take between three to four months, after which time we believe UL will renew the EC Certificate, once again permitting use of the CE Mark on our MRI compatible patient vital signs monitoring system. We expect to fully resolve this matter prior to the end of our second quarter,” president & CEO Roger Susi said in prepared remarks. “We expect this action may reduce full-year 2019 revenue by approximately 2%. After considering this impact, we still expect mid-20% revenue growth in 2019. We will provide our full-year 2019 revenue, GAAP and non-GAAP earnings guidance in our fourth quarter earnings release.”

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11 innovative medical devices you need to know from 2018


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Call it digital health or mHealth or simply what it is — innovation. Last year we saw a lot of innovative wireless devices for diagnostics and treatment as research and development flourished.

Many researchers have taken up the challenge of developing devices that are portable, small and convenient with ease-of-use that could revolutionize point-of-care diagnostics .

From a defibrillator for stroke to a smartphone app that can detect infectious diseases, here are 11 innovative medical devices that got our attention in 2018.

Next >>

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Philips touts new gantry design for Azurion

Philips Azurion with FlexArmPhilips (NYSE:PHG) today touted the launch of its Azurion with FlexArm, which the company said enables physicians to more easily perform image-guided procedures.

As the clinician moves the system, the image bean maintains alignment with the patient and provides consistent visualization, according to Philips.

Azurion with FlexArm moves on eight axes, controlled by the Axsys controller. In simulation tests, use of the system significantly reduced patient repositioning. This is of particular importance during minimally invasive procedures that require access through the patient’s wrist, Philips said, because it reduces the risk of unintentional pulling of wires and tubes.

Philips launched Azurion in February of 2017 and more than 450,000 people have been treated around the world since then, according to the Amsterdam-based company.

“With FlexArm, Philips’ engineers have overcome near-impossible geometric and mechanical barriers to enable clinicians to achieve clinical excellence in image-guided therapy,” Dr. Barry Katzen, founder & CMO of the Miami Cardiac & Vascular Institute, said in prepared remarks.

“FlexArm enables us to dramatically optimize procedures around the patient: we can get the optimal view of what’s going on inside the patient without encumbering all of the clinicians that are working around the table. The result is an innovation that’s not only clinically important but also very simple and intuitive to use – a critical factor in the heat of a complex procedure,” Katzen added.

“Two years on from its launch, Azurion is now established as our leading platform for interventional procedures, favored by clinicians for its intuitive, seamless approach that enables them to focus on treating the patient, and by hospital administrators for its positive impact on productivity and efficiency,” Ronald Tabaksblat, business leader for Philips’ image guided therapy systems unit, said. “FlexArm is the natural next step in our Azurion innovation journey, combining clinical and operational benefits to improve patient care and reduce costs, while opening up opportunities for new image-guided procedures as the field continues [sic] grow.”

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