October’s top stories: Royal Philips’ FDA approval, TissueCypher finds cancer-prone
Royal Philips’ S4-1 cardiac transducer for Lumify secured FDA 510(K) clearance and Cernostics’ TissueCypher identified Barrett's esophagus patients prone to cancer. Medicaldevice-network.com wraps-up the key headlines from October.
The US Food and Drug Administration (FDA) granted 510(k) clearance to Royal Philips to market its S4-1 cardiac transducer for its smart-device diagnostic ultrasound solution, Lumify.
The S4-1 transducer is a pocket-sized, lightweight device which has been designed to provide advanced sensitivity and high-resolution 2D image quality, coupled with new exam pre-sets, allowing clinicians to quickly triage and examine their patients.
The S4-1 transducer and cable weighs 152 grams, it is smaller than a smartphone making it versatile and mobile.
US-based medical device maker Cernostics announced that TissueCypher, in a clinical study, has identified high-risk Barrett's esophagus (BE) patients, who are 46 times more likely to have either high-grade dysplasia (HGD) or esophageal adenocarcinoma (EAC) at the time of biopsy than those patients who scored low-risk with TissueCypher.
The study concluded that TissueCypher, which is a tissue systems pathology test, has been found to better predict the presence of prevalent HGD and EAC in Barrett's esophagus patients than standard pathology testing.
TissueCypher had indicated high-accuracy in detecting the presence of prevalent HGD and EAC, even in biopsies with a pathologic diagnosis of non-dysplastic intestinal metaplasia (non-dysplastic Barrett's Esophagus).
Israel-based medical device company Sight Diagnostics (SightDx) will collaborate with the US Army Medical Research Directorate Kenya (USAMRD-K) for the development and testing of SightDx’s latest malaria diagnostic technology.
Under the collaboration, SightDx will develop and produce a portable malaria and complete blood count (CBC) reader which will be calibrated and validated through clinical trials at the USAMRD-K Field Station in Kisumu, Kenya.
SightDx CEO Yossi Pollak said: "We are very excited about the partnership with USAMRD-K.
US-based clinical trials laboratory services organisation Q2 Solutions’ EA Genomics entered into an agreement with Illumina to create a framework to develop next-generation sequencing-based (NGS) CDx assays.
The expansion of Q2 Solutions’ CDx development portfolio will boost its wide range of end-to-end services that extend from biomarker discovery and development to the application of precision medicine through its clinical trials laboratory network.
According to the agreement, Q2 Solutions will develop NGS assays using Illumina’s MiSeqDx instrument.
Medicrea gets FDA 510(k) clearances for PASS XS posterior fixation and LigaPASS XS band connector components
The Medicrea Group received two 510(k) clearances from the US Food and Drug Administration (FDA) for its PASS XS posterior fixation and LigaPASS XS band connector components intended to address pediatric spinal deformities in small stature patients.
The firm has teamed up with leading pediatric spinal surgeons to develop low-profile implants meant to meet the demands of pediatric deformity surgery.
The extra-small ‘XS’ extension of the PASS and LigaPASS technology will allow surgeons to effectively treat pediatric patients using around 40% less implant volume in each surgery and the lowest construct profile in-situ available on the market, whilst offering the same technical innovations of the PASS LP and LigaPASS systems used on adults and UNiD Lab patient-specific, digital surgical planning and analytical services.
US-based epigenetic data company Episona launched its new male fertility test, Seed, at the American Society for Reproductive Medicine Scientific Congress & Expo.
Seed evaluates epigenetic changes in DNA to predict the risk for male factor infertility and poor embryo development, offering physicians and their patients a new tool for personalising fertility treatment and boosting the chances of pregnancy quickly and cost effectively.
Episona president and CEO Alan Horsager said: "Physicians have long relied on the traditional semen analysis as the sole option for determining the male's role in fertility.
Second Sight Medical Products successfully implanted and activated a wireless visual cortical stimulator in a human subject during an ongoing University of California, Los Angeles (UCLA) study.
The study provided the initial human proof of concept for the development of the company’s Orion I Visual Cortical Prosthesis (Orion I).
The study is intended to demonstrate the initial safety and feasibility of Orion I as the human visual cortex stimulation.
Ascensia Diabetes Care launched the CONTOUR NEXT ONE blood glucose monitoring system (BGMS) in the UK.
The CONTOUR NEXT ONE BGMS features an easy-to-use, wireless-enabled smart CONTOUR NEXT ONE meter that connects to a smart mobile device via Bluetooth.
The meter provides an immediate feedback while seamlessly connecting to the CONTOUR DIABETES app, which collects, stores and analyses patient blood glucose results received from the meter.
Sony rolled out medical monitors to combine 4K and 3D imaging technologies, delivering high-brightness, enhanced resolution and increased depth of field for a range of medical applications.
The 4K 3D surgical monitors are LMD-X550MT (55”) and LMD-X310MT (31”) and are designed for use with 4K or 3D endoscopes and surgical microscopes in operating rooms, as well as in medical facilities for training and education.
The new monitors display 2D and 3D content in 4K or HD resolution.
US-based biotechnology company ORIG3N unveiled its nutrition focused new genetic test Fuel at the Food and Nutrition Conference and Expo in Boston, US.
The new test will assist consumers in learning how their genes cast an impact on their nutritional habit, weight and overall health.
Fuel is expected to reveal the genetic information which will guide consumers to adopt a nutritional habit to suit their specific sensitivities and metabolic factors.