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The article discusses how medical device makers are adopting strategies reminiscent of Uber’s disruptive approach to overcome barriers in the healthcare industry. It highlights the challenges faced by device manufacturers, including high costs and regulatory hurdles. By drawing parallels with Uber’s market entry tactics, the article suggests that some device makers are prioritizing market demand over regulatory compliance, potentially risking patient safety.

Abiomed, a subsidiary of Johnson & Johnson, has issued a recall for its Impella left-sided blood pumps due to a risk of heart perforation during procedures. The recall, classified as Class I by the FDA, follows reports of 129 serious injuries and 49 deaths associated with the devices. This marks the fourth Class I recall for Abiomed’s Impella devices in 2023 alone. The recall affects over 66,000 devices distributed in the U.S.

The agency advises U.S. suppliers, consumers, and healthcare organizations to cease using plastic syringes from two Chinese manufacturers immediately. Director Jeff Shuren stated that after further evaluation, quality issues are more widespread than initially known. Inspections revealed violations related to the sale and distribution of unauthorized syringes and breaches of quality system regulations. The FDA urges transitioning away from these syringes and avoiding other plastic syringes from China if possible.

This recall, which aims to correct the issue without removing the products from the market, affects 1,560 devices distributed across the U.S. from May 7, 2020, to December 18, 2023. The decision for the recall was made after the company reported eight injuries but no deaths related to the problem.

In a significant development for obesity treatment, the U.S. Food and Drug Administration (FDA) has approved a label expansion for Novo Nordisk’s obesity drug, Wegovy, allowing it to now include information about its cardiovascular benefits. This update marks the first time a weight loss medication has been recognized not only for its ability to help with weight loss but also to improve heart health outcomes.

In a recent development, the Centers for Disease Control and Prevention (CDC), following a meeting with its independent vaccine advisors from the Advisory Committee on Immunization Practices (ACIP), has decided to recommend a spring booster shot for individuals aged 65 and older. This decision, endorsed by CDC’s Director Dr. Mandy Cohen, came after an 11-1 vote, with one member abstaining.

Simon Frumkin, CEO of Fresh Wave, emphasizes the transformation healthcare is undergoing towards a device-led approach, supported by digital connectivity. This shift is marked by the increasing significance of SIM-enabled medical devices, such as infusion pumps, portable ECGs, ventilators, and ultrasound devices, which are revolutionizing patient care with their operational efficiency and flexibility.

In a recent development reported on March 8, 2024, Laura Perryman, the former CEO of Stimwave Technologies, was found guilty of healthcare fraud and conspiracy related to the marketing of a faulty implantable neurostimulation device. The device, intended for chronic pain treatment, was discovered to contain a non-functional component.

The FDA has issued a Class I recall, the most serious form, for Medtronic’s Duet External Drainage and Monitoring System Catheter Tubing due to the risk of catheter disconnection from the patient line stopcock connectors, which could lead to serious injuries or death. The recall affects product codes PCB, model numbers 46913 to 46917, with 45,176 devices recalled in the U.S. between May 3, 2021, and January 9, 2024.

In a troubling turn of events, a lawsuit has been filed against Intuitive Surgical Inc. by Harvey Sultzer, following the death of his wife, Sandra Sultzer. The lawsuit alleges that a malfunction with the company’s da Vinci surgical robot resulted in a fatal injury to Sandra during a colon cancer surgery. A stray electrical arc from the robot is said to have burned her small intestine, leading to complications that ultimately caused her death.