Tag: Medical device

First launched in 2007, the IGEL has since become a standard tool in anesthesia and resuscitation worldwide, reflecting a major advancement in airway management technology. When asking "what is an IGEL considered?" the definitive answer is a second-generation supraglottic airway (SGA) device, known for its unique non-inflatable cuff and ease of insertion.

Developed over years of extensive research, the i-gel is a unique single-use, non-inflatable supraglottic airway management device that has transformed modern airway control. This innovative tool, designed to work in perfect unison with the patient's anatomy, has a distinct set of applications. So, for what purpose is I gel used, and how does it compare to other airway adjuncts?

Under FDA regulations, a basic pill organizer is classified as a Class I medical device, intended to aid in medication management. While seemingly simple, this classification has significant implications for manufacturing, regulation, and consumer protection related to a **pill organizer**.

While many people associate FDA approval with new drugs, Osteoboost is not a medication but a wearable medical device. In early 2024, the U.S. Food and Drug Administration granted it clearance through the De Novo pathway, a distinct regulatory process from that for pharmacological agents.

According to the Food Allergy Research & Education (FARE), over 33 million Americans have food allergies, with many carrying an EpiPen for life-threatening anaphylaxis. Proper storage is paramount, so understanding if you **can an EpiPen be left in the cold** is a critical safety consideration for anyone who relies on this medication.

The U.S. Food and Drug Administration (FDA) does not approve dietary supplements for safety or effectiveness before they are marketed. This critical distinction is key when asking, 'Is Recell supplement FDA approved?', as there is public confusion between a legitimate, FDA-approved medical device called the RECELL® System and unapproved products marketed as supplements.

In 2024, Eroxon was launched in the United States as the first-and-only FDA-cleared, over-the-counter (OTC) gel for treating erectile dysfunction (ED). The product, which is now available both online and in-store at major retailers, can be purchased at Walmart without a prescription. This makes Eroxon a convenient and accessible treatment option for many men seeking to address ED concerns.

Millions of people worldwide live with glaucoma, a leading cause of irreversible vision loss, and for many, daily eye drops present a challenge to treatment adherence. Durysta was developed as a long-term solution to this issue, but its classification is often misunderstood: Is Durysta a medical device or something else?. It is in fact regulated as a drug delivery system, not a traditional medical device.

Inhalation therapy has a long history, with modern nebulizers offering an effective way to deliver medication directly to the airways. Understanding **how do you use inhalation solution** correctly with a nebulizer is crucial for patients managing respiratory conditions like asthma and COPD, as proper technique ensures the medicine reaches deep into the lungs.

In a 24-week clinical study, adults who used the medical device Plenity lost an average of 6.4% of their body weight, compared to 4.4% for those on a placebo. A common question that arises for those considering this treatment is: **Do you need a prescription for Plenity?** The answer is unequivocally yes, and understanding why involves examining its unique classification as a medical device rather than a traditional drug.