CleanNA introduces Clean Cell Free DNA Kit
The kit is intended for isolating cell-free DNA from human plasma in three steps. Credit: Furiosa-L from Pixabay. CleanNA has entered the molecular diagnostics market with the launch of its first CE-IVD-marked product, the Clean Cell Free DNA Kit. Featuring magnetic bead technology, the new kit is suitable for automation and application in diagnostic procedures. […]
Q&A with GlobalData thematic analyst
Cloud computing can help medical device companies to facilitate device recall and meet industry requirements. Credit: Shutterstock Jemima Walker is an associate analyst in GlobalData’s Thematic Intelligence team. Her expertise lies in the healthcare industry and in themes including cloud, robotics, ecommerce, healthtech, and cybersecurity. Lara Virrey: What are the biggest challenges facing medical devices […]
AliveDx secures IVDR certification for sites in UK and Switzerland
The IVDR certification replaces the previous In-Vitro Diagnostic Medical Device Directive (IVDD) after it was published in May 2017. Credit: esfera/Shutterstock. Switzerland-based vitro diagnostic company AliveDx has announced it received an In Vitro Diagnostic Regulation (IVDR) certification for its manufacturing sites in the UK and Switzerland. Both sites, one in Edinburgh, UK, and the other in Eysins, Switzerland, […]
Smileyscope secures FDA clearance for VR device in acute pain relief
Smileyscope’s Procedural Choreography technology sees negative stimuli are replaced virtually with friendly ones. Image credit: Shutterstock/Andrush. The US Food and Drug Administration (FDA) has cleared Smileyscope’s virtual reality (VR) device, which replaces painful or anxiety-inducing stimuli with friendly imagery. As per the FDA, the headset is cleared to temporarily reduce and/or manage pain and temporarily […]
Medicare sets preliminary payment for ReWalk’s personal exoskeleton
A final payment determination is expected in early 2024, with 1 April 2024 listed as the effective date. Image credit: ReWalk. The Centers for Medicare & Medicaid Services (CMS) in the US has set a preliminary payment determination of $94,617 for ReWalk’s personal prosthetic exoskeleton. The pricing comes as the agency included the device on […]
Signal: Medtech’s Covid boom is well and truly over as Avail, Olive shutter
Olive AI was once valued at over $4bn, but is now closing its doors. Photo: T. Schneider / Shutterstock.com. The Covid-19 pandemic was a hard time for many industries, but not medtech. Digital health funding alone hit $29.3bn in 2021, the highest ever. Companies like Olive AI and Avail Medsystems raised hundreds of millions as […]
MHRA issue caution with yellow card scheme
The eighth annual MedSafetyWeek campaign theme this year will focus on encouraging more scrutiny on medical products to ensure patient safety. Credit: LightField Studios/Shutterstock. Today marks the start of the 8th annual MedSafetyWeek launched by the Medicines and Healthcare products Regulatory Agency (MHRA). This year’s theme will be who can report? Encouraging patients, carers, and […]
XtalPi and CK extend partnership to develop AI cancer diagnostic models
In 2022, XtalPi and CK partnered to develop an AI-enabled cancer vaccine discovery platform. Image Credit: ArtemisDiana / Shutterstock. China-based companies XtalPi and CK Life Sciences have extended their partnership agreement to develop miRNA-based postoperative molecular diagnostic models for prognostic risk prediction. The companies plan to leverage and apply artificial intelligence (AI) algorithms developed by […]
Velsera, Solaris Health join forces to expand genetic testing in US
The partnership connects the genetic sequencing platform in the practice group’s laboratory to Velsera’s Clinical Genomics Workspace. Credit: Mahmoud Ahmed from Pixabay. Velsera and Solaris Health have collaborated to expand access to genetic testing in the US to help urology patients understand cancer risks. Solaris Health affiliates that are using the Genetic Interpretation and Clinical […]
Boehringer Ingelheim, Carelon Research conduct CKD tool study
The AI-driven tool leverages machine learning for assessing CKD progression risk using sex, age and routinely collected laboratory data. Credit: crystal light / Shutterstock.com. Boehringer Ingelheim Pharmaceuticals, along with Carelon Research, has carried out a validation study of a new artificial intelligence (AI)-driven tool for chronic kidney disease (CKD). Known as the Klinrisk model, the […]