The healthcare landscape has always been dynamic, ever-adapting to the challenges of the times and the needs of patients. Central to this evolution is diagnostic imaging, a field witnessing a revolutionary melding of innovation and care. Recent breakthroughs have magnified our ability to diagnose more accurately while emphasizing a patient-centric approach, ensuring that the individuals at the heart of this process are prioritized and understood. From Artificial Intelligence’s analytical power to imaging tools’ sustainable future,

Launching a new medical device involves more than just creating a great product. There’s a need to navigate a path filled with potential pitfalls, such as inadequate market research and insufficient clinical validation. If not properly managed, these pitfalls can become significant obstacles on your journey to success. At Gener8, we’ve walked this road many times and learned some important lessons along the way. Our experience spans various industries, including biotechnology, life sciences, and medical

The pursuit of accurate diagnosis is a cornerstone of effective healthcare delivery. The ability to correctly identify a disease or condition at its earliest stages can greatly enhance the patient’s prognosis, leading to improved outcomes and quality of life. Diagnostics have come a long way from mere physical examinations and symptom analysis. Microscopy, in particular, has played a pivotal role in understanding and diagnosing a plethora of conditions, especially in the realms of pathology and

The realm of healthcare is multifaceted and complex, but at its core lies the indispensable role of diagnostics. Diagnostics serve as the linchpin in healthcare, fueling our ability to identify, monitor, and manage diseases effectively. It’s a powerful tool in a physician’s arsenal, offering a window into a patient’s health status, informing treatment decisions, and facilitating the monitoring of disease progression or regression. Moreover, it plays a critical role in public health, informing disease surveillance

Genetic testing has become a critical component of modern medical diagnostics, enabling healthcare providers to detect genetic disorders, identify genetic predispositions to diseases, and guide personalized treatment strategies. At the core of many genetic testing methods is the Polymerase Chain Reaction (PCR) machine, a tool as integral to the modern molecular laboratory as the stethoscope is to a physician’s practice. The PCR machine, or thermocycler, has revolutionized molecular biology and genetics by allowing for the

In an era where digital transformation is revolutionizing healthcare, cybersecurity in medical devices has become a critical concern. Cyber threats are escalating, and the potential risk to patient safety and data privacy is growing. Recognizing this, the U.S. Food and Drug Administration (FDA) has prepared a comprehensive cybersecurity draft guidance document for medical device manufacturers. The draft guidance, released over a year ago, provides critical insights into the FDA’s expectations, and the final version is

Healthcare has always been an industry characterized by constant evolution and innovation. In recent years, one of the most significant shifts we’ve witnessed is the move toward patient-centric care that is accessible, personalized, and convenient. A key driving force behind this transformation is the advent of at-home diagnostic tests. At-home diagnostic tests, quite literally, bring healthcare into the comfort and safety of our homes. Enabled by technological advancements and fueled by changing consumer expectations, these

Read our white paper: “From Microscopes to Machine Learning: Identifying and Counting Blood Cells with Deep-Learning Models” This paper presents a new technique for identifying and counting different blood cell types in the human body using computers. It proposes a stain-free method that utilizes supervised machine learning algorithms, rather than traditional staining techniques. Three deep neural networks – U-net, Segmentation Transformer, and YOLO – were trained to accurately identify the five major white blood cell

Applications of POC Diagnostic Devices Point of care (POC) diagnostic devices produce results outside of laboratory settings by collecting and analyzing specimens at the time of the patient’s visit to the doctor’s office or outpatient treatment location. Patients can sometimes use point-of-care diagnostic devices at home, as with pregnancy or blood glucose tests. Technology advancements have expanded the applications of point-of-care diagnostic devices to provide a broader range of tests. Point-of-care testing devices can be

Lateral flow immunoassays—also known as lateral flow tests, lateral flow immunochromatographic assays, rapid tests, and strip tests—are a straightforward and accessible diagnostic technique. Lateral flow immunoassays offer fast results for a wide range of diagnostic applications, from home testing to laboratory use, The most common example of lateral flow tests is an over-the-counter pregnancy test. However, scientists and medical professionals also use these tests to identify diseases (such as Ebola or COVID-19), detect toxins in

Stereolithography (SLA) is a type of 3D printing technology that uses a laser to cure a liquid resin into a solid object.                         Stereolithography is one of the oldest types of 3D printing. The process applies laser light to photosensitive polymers (resins) to form models or prototypes under computer controls. The process helps medical device designers and other industrial creators visualize their concepts in three dimensions and refine their ideas as a result. The advantages

Top Three Best Practices for Biotech Product Development and Commercialization With so many rapid breakthroughs and disruptive innovations, biotech is constantly evolving.  The big question is, how do innovators like you take your concept to market while avoiding pitfalls that can slow down the process and risk your early-to-market advantage?  Designing and developing a product presents many challenges involving technical feasibility, build process, budget, regulatory compliance, and manufacturability. Getting assistance from a trusted partner with

Polymerase chain reaction technology allows scientists to copy and amplify DNA samples for more accessible study quickly The world of science and medicine never stops evolving. Every day, new technologies emerge and improve to give scientists more tools and methods to work with. Each innovation creates new and exciting potential across a wide range of fields and markets. One cutting-edge method that many industries are closely watching is the polymerase chain reaction. Polymerase chain reaction