Medtech in a Minute: Companies in Hot Water with FDA

Amanda Pedersen | Mar 25, 2023

Olympus Medical Systems is once again receiving ire from FDA as the agency issued another warning letter to the manufacturer after inspecting an additional Olympus facility in Tokyo, Japan. The letter notes a number of violations, but what stood out the most is that the company has received about 160 complaints about a distal end cover on one of its scopes dropping out, yet failed to consider that trend to be a quality data input to initiate a corrective and preventive action.

On the heels of supply chain issues, sterile packing problems, and CE mark suspensions, Getinge has to recall two models of intra-aortic balloon pumps (IABPs). FDA said the company is recalling the Cardiosave Hybrid IABPs and Cardiosave Rescue IABPs because the coiled cable connecting the display and base on some units may fail, causing an unexpected shutdown. This shutdown will occur without warnings or alarms to alert the user, the agency noted.

Nvidia and Cosmo Pharmaceuticals to develop a series of AI-based tools to help treat patients. The first product on the list is a colonoscopy tool that uses AI. The technology will integrate Nvidia's healthcare and edge technologies with Medtronic's GI Genius intelligent endoscopy model.

Baxter issued an urgent medical device correction through FDA for its Life2000 ventilation system due to risk for patient oxygen desaturation. The company said potential oxygen desaturation may occur under certain conditions when the system is connected with a third-party oxygen concentrator. Baxter inherited the device through its $12.5 billion acquisition of Hillrom in 2021. The company said patients can continue using the system if they follow daily checks and preventative maintenance requirements as detailed in the patient letter and instructions of use for both the Life2000 and third-party oxygen concentrators.

Hackers got ahold of personal data on more than 1 million patients (current and former) who use the Zoll LifeVest wearable cardioverter defibrillator. A company spokesperson told MD+DI the data breach does not affect the safety or operation of the LifeVest or any other Zoll medical device or related software. The breach occurred between January 28 and January 29, however Zoll just issued the data security notice on March 10. Hackers acquired patient names and other personal identifiers in combination with social security numbers.

Medtronic is emerging as a front-runner in pulsed field ablation (PFA) with a new regulatory approval in Europe, but Boston Scientific and Johnson & Johnson are hot on its heels. At least three private companies are also developing PFA technologies. PFA has recently captured the attention of the electrophysiology community with the expectation of achieving safer and faster procedures based on the selective effect on the myocardium as compared to currently dominant point-by-point RF ablations.

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