With FDA approval, AtriCure's EPi-Sense becomes the only approved hybrid therapy for the most severe atrial fibrillation (Afib) patients. The device is supported by strong 18-month clinical trial data.In addition to superior clinical results, the procedure significantly improves electrophysiology lab efficiency by reducing endocardial ablation times by over 40 minutes, improving throughput and enabling more patients to be treated, according to the company.
Illumina filed an action to annul the European Commission’s decision to have the Grail acquisition reviewed. About a week earlier, the European Commission Directorate-General called for antitrust regulators to examine Illumina’s $8.1 billion acquisition of the liquid biopsy specialist. This measure would have Illumina, a genomic sequencing specialist, put in a request for approval of the merger. If there are serious concerns, then there could be a full-scale investigation of the deal.
FDA has authorized a breakthrough device for patients 18 and older undergoing stroke rehabilitation to facilitate muscle re-education, and for maintaining or increasing range of motion. The Neurolutions IpsiHand Upper Extremity Rehabilitation System is a brain-computer interface device designed to assist in rehabilitation for stroke patients with upper extremity (hand, wrist, and arm) disability. The IpsiHand System uses non-invasive electroencephalography (EEG) electrodes instead of using an implanted electrode or other invasive feature to record brain activity. The EEG data is then wirelessly conveyed to a tablet for analysis of the intended muscle movement (intended motor function) and a signal is sent to a wireless electronic hand brace, which in turn moves the patient’s hand.
And in case you missed our last Medtech in a Minute report...
AliveCor wants to block the importation of all the Apple Watches in the United States, and claims the tech giant is infringing on three counts of ECG patents. AliveCor's complaint, which it filed with the U.S. International Trade Commission, follows a federal lawsuit AliveCor filed in December alleging Apple of patent infringement. Apple won FDA clearance for its ECG app in September 2018.
Regulators are pulling out all the stops to block Illumina and Grail from reuniting. The Federal Trade Commission says the $8 billion deal would diminish innovation in the U.S. market for multi-cancer early detection (MCED) tests. And now, the European Commission Directorate-General is reportedly scrutinizing the deal, following a request from six countries on competition concerns. Illumina launched Grail in 2016.