According to the FDA's guidance document on when to submit a 510(k) for changes to an existing device, manufacturers must submit a new 510(k) if there are significant changes to the device's design, materials, or intended use.
AseptiScope CEO Scott Westhaver Mader uses a process he calls "Market-Driven Science," to identify critical attributes required to resolve unmet challenges in healthcare.
According to Brown, most providers, especially independent practitioners and smaller hospitals/clinics/ambulatory surgical centers (ASCs), do not have the resources to go after these claims, with their office administrative staff lacking the expertise or the bandwidth to perform the appropriate tasks.
According to Dr Patrick Yassini, simple shifts in medical paradigms and physician mindsets could lead to a better healthcare system for everyone.
In a unanimous decision, the Supreme Court permitted doctors to mail the pills to their patients even without an in-person visit. Justice Brett Kavanaugh wrote the opinion on the case, citing lack of standing as the grounds for the decision.
The FDA panel voted 9-2 on whether it was effective and voted 10-1 on whether the proposed MDMA treatment is safe or if its benefits would outweigh the risks.
Dr. Alsheikh points out the major dislocation between social expectations and cost, which do not compute with the economic realities.
For Debra Reis, an experienced and passionate nurse with over 40 years in the industry, these challenges transformed into the inspiration behind Reis Wellness Services (RWS), providing innovative programs supporting healthcare facilities through empowering nurses.
With Medicare continuing to cut physicians' pay, being a physician, especially if they own a healthcare delivery facility such as a clinic or medical center, is becoming more financially unsustainable.
Benevolent Family Services (BFS), a behavioral health company headquartered in Hampton, Virginia, has introduced an innovation in the delivery of mental healthcare services.
In its efforts to make substance use disorder (SUD) treatment more accessible, CODAC developed a Mobile Medical Unit initiative that delivers essential care and medicine to underserved communities.
PuraVida's KidsLife™ Products promote healthy eating habits from a young age, educating parents and children about nutrition through resources like nutritional facts and meal planning tips.
In a post-COVID world, society is branching away from pharmaceutical medicine and seeking support that may be less likely to cause side effects.
In the US, 19% of married women with no prior births experience infertility, while 26% have difficulty getting pregnant or carrying a pregnancy to term.
The perfect CrossFit shoe strikes a balance between the flexibility of a running shoe and the stability of a weightlifting shoe, which is essential for squats and deadlifts.
In an American Psychological Association poll, 86% of adults believe individuals with mental health disorders can improve. Dr. Olivia West, or Dr. O, is dedicated to assisting those struggling with mental health, bridging the gap for those facing difficulty accessing help.
If you wish to enjoy smiling and carrying conversations, without having to worry about your lips, then you need to have the best lip balm within your reach.
The opioid crisis, fueled by over prescription of painkillers, has had further devastating consequences on mental health.
The upcoming Supreme Court case on mifepristone access in abortion procedures sparks contentious debates that strike at the heart of the controversial issue.
Nvidia and Novo Nordisk's joint venture, Gefion, represents a groundbreaking endeavor in medical research, leveraging AI technology.
The new law, a Republican-backed initiative, does not directly address the personhood issue at the core of the Supreme Court ruling but aims to provide civil and criminal immunity to IVF providers and patients for the destruction or damage to embryos.
Piping Rock's commitment to sustainability goes beyond mere rhetoric; it is embedded in the fabric of the company's operations.
UnitedHealth confirms Blackcat ransomware group as responsible for the cyberattack on its division, prompting urgent cybersecurity measures.
Oprah Winfrey's exit from WeightWatchers sparks uncertainty and market turmoil amid heightened competition.
Elon Musk's Neuralink achieves a major breakthrough as patient controls computer mouse with thought, but is it the game-changer the tech company is claiming?
CDC may soon allow Covid-19 patients to stop isolation after 24 hours fever-free and improving symptoms.
Uncover the vital role of laundry detergents in your life by choosing one of the high-quality options compiled here.
Finding the best deodorant for women will help ensure that you stay confident all day long. Here are some of the best deodorants for every woman's needs and lifestyle.
By prioritizing comfort, support, durability, and performance, you can find a pair of running shoes that will unlock a world of running joy.
The perfect pillow is a necessity for neck pain relief. Here, you can explore ergonomic designs, memory foam options, and tailored solutions for restorative sleep.