Transcranial Magnetic Stimulation (TMS) is a non-drug treatment for illnesses like depression which is gaining clinical adoption after FDA clearance of new protocols such as SAINT. Brain Frequency LLC and Wave Neuroscience Inc. both offer types of personalized TMS involving a pre-procedure electroencephalogram (EEG) assessment. In recent Western District of Texas patent … [Read more...] about What level of experience is required for expert testimony?
Medical Devices
The Cybersecurity Sword Hanging Over Medical Device Manufacturers
Introduction In September 2023, the U.S. Food and Drug Administration (FDA) issued a pivotal guidance document titled Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions. This guidance aims to bolster the cybersecurity of medical devices, thus safeguarding patients, healthcare facilities, and the broader healthcare ecosystem … [Read more...] about The Cybersecurity Sword Hanging Over Medical Device Manufacturers
Medical device security expert witness: improving critical products
Medical devices -- engineering inventions to improve human health -- have more than a century of history, with the global medical device market size predicted to exceed $600 billion by 2025. Most products in this market share a common feature: network connectivity. Figure 1 shows a typical example: even something as mundane as a pump bristles with features allowing it to … [Read more...] about Medical device security expert witness: improving critical products
Medical Device Software Standard of Care Expert Witness: Causes, Standards & Issues
What Medical Device Software is What is medical device software? And why would its “standard of care” be an important subject? In simple terms, medical device software is a component of, or an accessory to, a piece of electronics that interacts with the human body (see figure 1). “Standard of Care” is a key phrase in many areas of law and expert witnessing. In … [Read more...] about Medical Device Software Standard of Care Expert Witness: Causes, Standards & Issues
Medical Device Expert Witness: How Technology Saves Lives
Engineering inventions to improve health date back at least to 1850, when the famous physicist Hermann von Helmholtz devised the ophthalmoscope. One of the first medical devices, it allows a doctor to look at the interior of a patient’s eye. In the latter part of the 20th century the pace of innovation in medical devices increased dramatically, with a global market size … [Read more...] about Medical Device Expert Witness: How Technology Saves Lives