Yesterday the agency classified the recall of privately held Vyaire Medical’s respiratory support devices as most serious and said their use could cause major injuries or death.
Tag Archive for: Medical Devices
The FDA stated that it has not authorized, cleared, or approved any smartwatch or smart ring that is intended to measure or estimate blood glucose values on its own.
Most medtech companies can’t seamlessly exchange product information between in-country and global regulatory assurance teams, according to the 2023 Regulatory Benchmark Report from Veeva MedTech. Without a standardized and consistent way to share documents globally, organizations can’t ensure the reliability or accuracy of product information across markets. This increases compliance risk.
The company announced that it will not sell new devices to treat sleep apnea in the United States in the coming years as it works to comply with a settlement with the Food and Drug Administration.
Medical device makers are seeing higher demand for their products due to a steady recovery in surgical procedures that were deferred during the pandemic, especially by older adults, as well as easing staff shortages at hospitals.
The maker of insulin pumps has been trying to ease investor concerns that strong demand for a new class of diabetes drugs that also aid in weight loss could hit the sales of Insulet’s insulin pumps.
The company’s new campaign, “Countdown at a Crossroads” featuring TV host Sherri Shepherd, shines a spotlight on how CGM technology can help people living with diabetes improve health outcomes and have a better quality of life.
Bariatric surgeries grew at modestly lower rate in third quarter compared to the previous quarter, financial head Jamie Samath said, adding the company was gaining market share in the surgical segment.
U.S. companies across sectors such as food and beverage makers and manufacturers of glucose monitors have faced investor questions over the risk to future sales from the growing popularity of promising weight-loss treatments.
Without consumer health and with its orthopedics business undergoing restructuring, pressure on J&J’s large pharmaceutical unit is likely to intensify as the company aims to reach its goal of $57 billion in drug sales by 2025.
