Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Anx Robitica, B-rayz, Imvara, Reflow Medical.
Researchers from Indiana University are seeking patent protection for an electromagnetic field (EMF) generation system for treating neurodegenerative diseases. The EMF generation system emulates a small-scale magnetic resonance imaging (MRI) machine, producing the same 64 MHz frequency at a much lower operating power.
The U.S. FDA has announced a class I recall of Iveninx large-volume infusion pumps made by Fresenius Kabi USA of Lake Zurich, Ill., due to a mechanical issue with fluid valve pins that could cause the pumps to shut down. Fresenius is rolling out a remediation plan for more than 900 pumps affected by the recall, which to date has been associated with no reports of injury or death.
The history of med-tech patent litigation is replete with long-running conflicts that test the willpower of the participants, which increasingly seems to be the case in a series of lawsuits between Masimo Corp. and Apple Inc.
Onera Technologies BV raised €30 million (US$32.7 million) in a series C funding round that will allow the company to accelerate the manufacturing and deployment of its patch-based sleep test system. The funds will also go towards concluding the development of the company’s second-generation polysomnography (PSG) system.
Investors bailed on many med-tech companies last year, fearing that the frenzy surrounding GLP-1 agonists would tank companies in the weight-loss, diabetes and orthopedics segments. Their concerns now appear overblown in many instances, with some of the most directly affected businesses reporting a “rising tide” associated with an increased focus on obesity treatment that has lifted their boats rather than sinking them.