Making CES history, Abbott presented a keynote at the most influential tech event in the world, the first healthcare company ever to do so. Abbott Chairman and Chief Executive Officer Robert B. Ford headlined the event, “Human- Powered Health: Unlocking the Possibility of You.”

"Technology gives us the power to digitize, decentralize and democratize healthcare, create a shared language between you and your doctor – and put more control of your health in your hands," Ford said. "We’re creating a future that will bring you and your loved ones care that's more personal and precise. It’s happening right now. And its potential is no less than incredible."

Lingo – Speaking your body’s unique language
During the keynote, the company announced it’s developing a new category of consumer biowearables called Lingo. These biowearables are being designed to translate your body’s unique language into actionable data to help you track and measure your general health and wellness. The sensor technology is being designed to track key signals in the body such as glucose, ketones, and lactate, and could also be used one day to track alcohol levels.

"This will be like having a window into your body," Ford said. "It’s science that you will be able to access any time so you can understand what your body is telling you and what it needs. Our vision is that Lingo will go far beyond today’s wearables for consumers to help you proactively manage your health, nutrition and athletic performance.”

Lingo extends the Abbott sensing technology platform that Abbott pioneered in 2014 for people with diabetes, allowing people to continuously monitor their glucose levels with a small sensor on the back of the upper arm. Actress and comedian Sherri Shepherd shared live on the CES stage how FreeStyle Libre 2 changed her life, giving her glucose readings, right on her smartphone, unique to her body so she can make healthier decisions.

Abbott then built this technology platform to develop a product designed for athletes with the 2020 launch of Libre Sense Glucose Sport Biowearable in Europe. Elite athletes, like marathon world record holder Eliud Kipchoge, use this biowearable to optimize how they fuel their bodies for rigorous training. Lingo aims to expand glucose monitoring to people looking to manage their weight, sleep better, improve energy, and think clearer.

Abbott is designing Lingo to measure other biomarkers beyond glucose in the future. A ketone biowearable is being developed to track ketones continuously, see how fast you are getting into ketosis, and understand exactly what keeps you there by providing insights on dieting and weight loss. A lactate biowearable is in development to track continuous lactate build up during exercise, which can be used as an indicator of athletic performance.

A human focus
Beyond those who demonstrated the human impact of Abbott’s sensors, Ford was joined on stage by people whose lives were impacted by Abbott devices, partners who rallied to provide seamless and safe travel experiences and other visionaries in the industry.

• Tyrone Morris, a heart failure patient who was given six months to live, shared his story of how he beat the odds thanks to three separate Abbott devices: HeartMate 3, CardioMEMS and an implantable defibrillator. Today, Morris owns a barbecue catering business and food trucks in Humble, Texas, where he specializes in low-sodium recipes.
• United Airlines’ Managing Director of Hospitality & Planning Aaron McMillan and Dr. Patrice Harris, co-founder and CEO of eMed, a digital health company democratizing healthcare through its Digital-Point-of-Care^TM platform, described how they came together with Abbott to help people fly confidently and conveniently with BinaxNOW COVID-19 Home Tests. United customers can take the proctored tests when traveling and have those results seamlessly confirmed by Abbott’s NAVICA app and verified through United’s Travel Ready Center.
• Dr. Fiona Gupta of Mount Sinai Health System in New York highlighted how she uses the NeuroSphere Virtual Clinic, a first-of-its-kind technology in the U.S., that provides people with deep brain stimulation remotely, so physicians can optimize and adjust treatments over cellular or Wi-Fi while Parkinson’s and chronic pain patients consult with them from the comfort of their living rooms.
• The head of the University of Southern California’s Center for Body Computing Dr. Leslie Saxon shared her vision of “Lifecare,” which addresses everything from preventing sudden deaths to enhancing human performance.
• Dr. Mary Rodgers, an Abbott virus hunter, shared how a first-of-its-kind network called the Abbott Pandemic Defense Coalition – stretching from Brazil to Senegal to Thailand – is working to identify new viruses and help stop them before they can spread.
• Dr. Hakim Bouzamondo, head of Nutrition research and development at Abbott, shared how the science behind the microbiome can optimize overall health with personalized nutrition.

Catheters are of paramount importance for minimally invasive surgery. They enable interventions such as the removal of blood clots, the insertion of implants, or the targeted administration of drugs, and are intended to be particularly gentle for patients. In general, the less invasive the catheter procedure, the lower the risk of medical complications and the shorter the recovery time.

However, there are limits. For instance, previously developed sensors and actuators were still integrated by hand into electronic catheters. In addition, control, and placement of catheters in the body are limited, because the tiny instruments have to be maneuvered externally by the surgeon in a complex environment or placed with robotic assistance. This has significant disadvantages for miniaturization and the use of flexible structures that need to adapt to the body for particularly gentle use in surgery. It has also been difficult to integrate additional sensors and functions into micro-catheters, which hampers their potential applications.

Under the supervision of Prof. Dr. Oliver G. Schmidt, head of the Professorship for Material Systems for Nanoelectronics, designated Scientific Director of the Center for Materials, Architectures and Integration of Nanomembranes (MAIN) at Chemnitz University of Technology and former Director at the Leibniz Institute for Solid State and Materials Research (IFW Dresden), scientists at IFWDresden in cooperation with the Max Planck Institute for Molecular Cell Biology and Genetics (CBG) have now presented the world's tiniest flexible, microelectronic microcatheter.

Smart functions – as thin as a hair
In this smart microelectronic tool for minimally invasive surgery, the electronic components for sensors and actuators are already integrated into the catheter wall from the outset. "Due to the special manufacturing method, the embedded electronic components have no effect on the size of our catheters, which can thus be as thin as a single hair", says Boris Rivkin, lead author of the study, who is pursuing his doctoral graduation at Chemnitz University of Technology and his dissertation at Leibniz IFW Dresden. The instruments have a tiny diameter of only 0.1 mm and are also characterized by their flexibility, resilience, and high biocompatibility. "Using microchip technologies to manufacture the microcatheters allows us to generate completely new types of biomedical and multifunctional tools," adds Prof. Schmidt. Such smart tools could be used, for example, in minimally invasive treatments of aneurysms, vascular malformations, or pancreatic surgery.

The research team reports on the World’s smallest Microelectronic Catheter in a publication entitled "Electronically integrated microcatheters based on self-assembling polymer films" in the current issue of the prestigious journal Science Advances.

Flexible and equipped for diverse applications
Prof. Schmidt and his team integrated magnetic sensors for navigation and positioning into the micro-catheter. Like a compass, this tracking relies on weak magnetic fields instead of harmful radiation or contrast agents, and would thus be applicable in deep tissue and under dense materials such as skull bones.

The microelectronic microcatheter integrates a channel for fluids. Through this microfluidic system drugs or liquid embolic agents could be delivered directly to the point of use. The catheter tip is equipped with a tiny gripping instrument that allows the catheter to grasp and move microscopic objects. The removal of minute tissue samples or blood clots are suggested as potential applications. This highly flexible use of embedded microelectronics is made possible by integrated electronic components based on the Swiss-Roll Origami Technology. By this technology the team can construct highly complex microelectronic sensor and actuator circuits on a chip, which are then triggered to roll up by themselves into a Swiss-Roll microtube structure. The multiple windings of the Swiss-Roll architecture significantly increase the usable surface area and monolithically integrate sensors, actuators and microelectronics into the compact wall of the tubular microcatheter. 

Prof. Schmidt and his team have pioneered this technology for some time. Extremely thin, shapeable polymer films have proven useful for a microtube architecture that can geometrically adapt to other objects, for example, cuff implants as bioneural interfaces. Another application scenario targeted by this technology are catalytic micromotors and platforms for electronic components to create microelectronic swimming robots.

The microelectronic microcatheter bridges the gap between electronically enhanced instruments and the size requirements of vascular interventions in submillimeter anatomies. In the future, additional sensor functions can be integrated, expanding the range of potential applications. For example, sensors for blood gas analysis, biomolecule detection, and sensing physiological parameters such as pH, temperature, and blood pressure are conceivable. Entirely new and flexible applications for minimally invasive surgery are coming into the realm of possibilities.

Norman Noble Inc., a leading contract manufacturer of next-generation medical implants, has achieved ISO 13485:2016 registration for its Quality Management System (QMS) following a recertification audit by the British Standards Institute (BSI), a European Union Notified Body.

ISO 13485:2016 is an internationally recognized quality standard specific to the medical device industry. ISO 13485:2016 registration demonstrates Norman Noble’s continued commitment to the highest level of medical device product quality and regulatory compliance. ISO 13485 registered since 2004, this update supports our customers’ efforts to maintain compliance with the latest domestic (FDA) and international (MDSAP and European MDR) regulatory requirements.

A new white paper from RQM+, the leading regulatory, quality, and clinical consulting firm, provides clarity on the clinical evidence required to comply with the EU In Vitro Diagnostic Regulation (IVDR), and spotlights synergies between EU and US requirements.

It is imperative that manufacturers do not underestimate the time required to source the right clinical evidence for their products. As the risk to individual and public health increases with each device classification under the IVDR, the corresponding conformity assessment requirements also increase. This new rigorous risk-based classification means that an estimated 84% of IVDs now fall under Notified Body (NB) scrutiny compared to the mere 7% under the directive.

To ensure that IVDR compliance is as efficient as possible, manufacturers must check whether they can leverage existing clinical evidence from IVD submissions to the US Food and Drug Administration. If a company sells diagnostic products that are 510(K) cleared in the USA, then they may have a head start. It is likely they have already obtained a significant proportion of the supporting testing and performance data that is required to comply with some of the IVDR requirements.

This new white paper from RQM+ provides advice on how to identify synergies, as well as a table that clearly presents areas where these synergies may be found. This is an addition to a detailed summary of clinical evidence requirements under the IVDR, including a checklist of questions to assess whether scientific validity, analytical performance and clinical performance have been sufficiently addressed in their Performance Evaluation Report (PER).

Carlos Galamba, vice president, IVD Intelligence and Innovation, says, “The EU Commission’s recent proposal could mean a sigh of relief for some IVD manufacturers with existing directive products on the market. If approved, it would not change the date of application, but it would allow for a progressive roll-out to the IVDR based on device classification, with a shorter timeframe for higher risk devices.

However, there is no room for complacency. Notified Bodies will not engage with companies unless their technical documentation, including performance data is complete. I cannot stress enough how important it is for IVD manufacturers to review whether they have enough clinical evidence, to give themselves enough time to take remedial action. We hope that this new paper will help manufacturers to plan efficiently for compliance, by making full use of what is already available.”

Download the RQM+ white paper, ‘Performance Data and EU IVDR: Improving operational efficiencies through compliance’, here.