There’s nothing scary for Ametek Inc. shareholders in the $1.9 billion acquisition of Paragon Medical Inc. announced on Oct. 31, 2023. The deal moves the industrial technology company solidly into the med-tech space as it picks up Paragon’s portfolio of products in orthopedics, minimally invasive surgery, robotic surgery and drug delivery, and adds an estimated $500 million per year in revenue and “very strong EPS accretion,” Ametek CEO David Zapico said in an investor call on Oct. 31.
As more and more artificial intelligence (AI)-based solutions get developed to improve patient care, humans should ultimately remain in control because no AI system will be free from mistakes, said Ha Hong, Chief Artificial Intelligence Officer in Medtronic plc’s Endoscopy unit. “There will be some errors, it is simply not possible to create a system that is 100% error free,” he told BioWorld in an interview.
The U.S. FDA’s draft rulemaking for regulation of lab-developed tests (LDTs) came with a conspicuously short comment period of 60 days, but the agency is unresponsive to requests to add another 30 days to the comment period. Read More
The U.S. Centers for Medicare & Medicaid Services (CMS) has released the prospective payment rule for end-stage renal disease (ESRD) for calendar year 2024, and advocates had some luck prompting the agency to boost the base ESRD payment rate. However, Atlanta-based Pain Care Labs Inc. came up short in its transitional add-on payment application for the Buzzy Pro for relief of puncture wound site pain because, according to CMS, the device does not represent a substantial improvement over currently available remedies.
Olympus Medical Corp. instituted a class I recall of its UHI-4 high flow insufflation device due to reports that the device may over-inflate and potentially create embolisms. The recall affects more than 3,100 units distributed in the U.S. between May 2012 and August 2023, all of which should not be used until the company resolves the problem. Read More
Pulkit Grover, associate professor of electrical and computer engineering at Carnegie Mellon University, reported a new approach for electrode placement that explicitly exploits the thresholding phenomenon of neurons to achieve significant gains in focal neural stimulation. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Movano, Shenzhen Maiwei, Sebela, Skylinedx. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Acuitymd, Body Vision, Cardio Diagnostics, Desktop Metal, Fabric Genomics, Geminiov, Guardant, Livsmed, Lucid Diagnostics, Microbot Medical, Orthoventions, Oxford Nanopore, Pavmed. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Xenix. Read More
