IMDA eNews 110123

The latest news affecting you and your customers…

from the Independent Medical Specialty Dealers Association

New AI medical devices climbing in numbers

The FDA reports that it cleared for marketing 171 new medical devices including artificial intelligence or machine-learning features between August 2022 and July 2023, bringing to nearly 700 the total number of such devices to have received marketing authorization, reports MedTech Dive. Last year, when the FDA first unveiled the list, MedTech Dive found that the majority of cleared AI/ML devices were used in radiology and went through the agency’s 510(k) clearance pathway. That continued to be true in the most recent period. GE HealthCare has had the most authorized AI/ML devices to date.

Oxygen status device cleared for marketing

Masimo announced that Ori™, a noninvasive, continuous parameter designed to provide additional insight into a patient’s oxygen status in the moderate hyperoxic range under supplemental oxygen, was granted a De Novo clearance by the FDA. According to the company, ORi is the first-of-its-kind parameter cleared by the FDA to help clinicians manage oxygen of adults undergoing surgery in perioperative hospital environments. There is growing evidence that hyperoxia is harmful and can lead to oxygen toxicity, causing oxygen poisoning or pulmonary tissue damage.

FDA clears continuous effusion shunt system

Minnesota-based Pleural Dynamics reported it received FDA 510(k) clearance for its ACES™ Automatic Continuous Effusion Shunt System. The technology is designed to use normal breathing motion to automatically pump pleural effusion fluid out of the chest to the abdomen for reabsorption by the body, eliminating the need for an external catheter and frequent drainage.

Insufflation device is recalled

After reports of patients experiencing arrhythmias during surgical procedures in which Olympus Medical’s High-Flow Insufflation Unit, Model UHI-4, was used, the company is recalling the device, reports Medical Device and Diagnostic Industry. The UHI-4 is designed for insufflation of the abdominal cavity for diagnostic and operative laparoscopy, Olympus said it initiated the recall after reviewing reports of patient injuries and one death which, according to the FDA recall entry, “may have been due to an over insufflation of the abdominal cavity resulting from use of the UHI-4 during the procedures.” The recall effects 3,136 units in the United States, according to the FDA filing.

‘Smart scalpel’ measures users’ force

Investigators from the University of Edinburgh report that its “smart scalpel” can assess how much force users are applying during surgical procedures and quantify how they controlled the device over time, according to Medical Device and Diagnostic Industry
font-weight: 400;”>. Despite the central role that forces play in surgery, the analysis of these remains a novel area of research, as most methods for analyzing these skills are vision-based and mainly focus on instrument motion, according to the researchers. However, there is some evidence that force-based performance metrics can be superior to metrics that are based on movement alone, they said, adding that recent studies also indicate that tool-tissue interaction forces can uniquely reflect a surgeon’s competence.

2024 Conference: The value in being there

There’ll be plenty of learning inside and outside the meeting rooms at the 2024 IMDA/HIRA Conference in Orlando, Florida, March 4-6. In general sessions, you’ll receive updates on issues like how to deal with the threat of cyberattacks, how to navigate the world of contracts, and how to meet the clinical and financial needs of your customers. And outside the meeting rooms you’ll exchange ideas with peers during cocktails and shared meals, the Manufacturers Forum, and, of course, the golf course for those of that persuasion. Come to the 2024 IMDA/HIRA Conference. There’ll be a whole lot of learning going on. And it’s all for just $750 for IMDA members. Click here for more information.