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Edwards also plans to utilise the after-tax proceeds to explore new therapeutic areas for interventional heart failure. Credit: Peakstock / Shutterstock

BD (Becton, Dickinson and Company) has agreed to acquire the Critical Care product group from Edwards Lifesciences in an all-cash deal valued at $4.2bn.

The Critical Care product group will continue to operate out of Irvine, California, US. 

It will operate under the leadership of Katie Szyman, the current corporate vice president of Critical Care for Edwards.

Subject to customary closing conditions, including antitrust and foreign investment approvals, the transaction is expected to close by the end of this year.

The decision to sell the Critical Care unit to BD marks a shift from Edwards’ previously announced intention to spin off the business.

Edwards CEO Bernard Zovighian said: “Edwards’ underlying rationale for separating Critical Care remains the same: we are laser-focused on pursuing a strategy centred on structural heart disease.

“Our goal is to serve large unmet patient needs with our differentiated innovations while extending our global leadership, delivering sustainable growth and increasing shareholder value. "

The US Department of Health and Human Services’ Health Sector Cyber Coordination Center has warned healthcare entities about serious security issues in two medical device products from Baxter, namely the Baxter Welch Allyn Configuration Tool, and the Baxter Welch Allyn Connex Spot Monitor (CSM).

This follows two ICS Medical Advisories for Baxter products from the Cybersecurity and Infrastructure Security Agency (CISA), denoting a “high” risk associated with the flaws. If someone takes advantage of these flaws, they could gain access to sensitive information such as passwords or change important settings and software on the devices. This tampering could compromise the devices and disrupt patient care.

Baxter advised that any passwords used with the configuration tool should be changed immediately to prevent potential problems.  

Research has found that the use of robots paired with artificial intelligence (AI) to treat stroke patients autonomously could improve access to and speed of time-sensitive procedures.

The study, published by Kings College London, titled: “Autonomous navigation of catheters and guidewires in mechanical thrombectomy using inverse reinforcement learning,” sought to examine how the autonomous navigation of catheters and guidewires could enhance endovascular surgical safety, reducing procedure times and operator radiation exposure.

The results found that using a system known as inverse reinforcement learning (IRL) to train the AI, researchers saw success rates of 100% and procedure times of 22.6 seconds when using what is known as ‘Reward Shaping’ techniques to train the AI. Similar to reward shaping in animals, the technique with AI involves the system being rewarded with supplemental data as a means of reinforcing behaviour with researchers seeing significant results. 

Roche has launched an in vitro diagnostic assay, Ventana Kappa and Lambda Dual ISH mRNA Probe Cocktail assay, in countries that accept the EU CE mark.

The Ventana B-cell lymphoma diagnostic assay is designed to qualitatively detect Kappa mRNA and Lambda mRNA. The test detects the presence of B-cell lymphomas and plasma cell neoplasms in formalin-fixed, paraffin-embedded (FFPE) human bone marrow and lymphoid tissue.

The increased sensitivity of the test allows for the assessment of more than 60 subtypes of B-cell lymphoma and plasma cell neoplasms on a single tissue slide. The test can also be performed on small biopsies and formalin-fixed tissue, thereby reducing the need for a fresh tissue sample, which may not be available, especially if lymphoma was not originally suspected. 

Six months after tagging a recall for Megadyne’s Mega Soft Universal Patient Return Electrode as Class I, the US Food and Drug Administration (FDA) has issued another Class I rating for the paediatric version of the device.

The recall is due to reports of patient burn injuries whilst using the device. Health consequences include third-degree burns, scarring, and the need for additional surgeries.

In a letter to customers, Megadyne requested facilities and providers to stop using the devices. “Customers are required to immediately return all Megadyne Mega Soft Paediatric Patient Return Electrodes subject to this recall,” the FDA notice stated.

In a May statement, Magadyne said: “A root cause investigation on the reports included testing which showed a combination of factors when present together may result in potential for thermal injuries.