Woven Orthopedic Technologies LLC, received U.S. FDA 510(k) clearance for its Ogmend implant enhancement system for use in spine surgery. Ogmend is expected to give surgeons more confidence in using surgical screws when operating in compromised fixation scenarios.
The U.S. FDA reported that Baxter International Inc. issued an Urgent Medical Device Correction for its Life2000 ventilation systems in response to reports of potential patient oxygen desaturation events when connected to a third-party oxygen concentrator.
Vivasure Medical Ltd. received a €30 million (US$32 million) strategic investment from Haemonetics Corp. to help develop its Perqseal closure device system which manages bleeding complications associated with large-bore arterial vessel closure. Haemonetics has an option to buy Vivasure upon the completion of the company achieving certain milestones.
From Carl Icahn’s point of view, Illumina Inc.’s desired reintegration of its former spinoff is more a poisoned chalice than a holy Grail. In his opening salvo to a proxy fight, Icahn published an open letter March 13 to other Illumina shareholders referencing the “extreme displeasure” of investors with Illumina’s “reckless” determination to acquire Grail Inc., despite European regulators’ strong opposition to the deal.
Methinks Software SL (dba Methinks.AI), a digital health company, is working on the U.S. FDA submission for its artificial intelligence (AI)-based stroke triage software, which will aid in the detection of acute stroke, after recently receiving CE mark certification.
Europe has given device makers more time to meet requirements set out in the 2017 Medical Devices Regulation (MDR). The European Parliament approved in mid-February an extension of the transition periods for medical device and IVD manufacturers to comply with the new rules, which aim to enhance safety for patients and ensure the “smooth functioning of the internal market.”
Theranica Bio-Electronics Ltd. broadened its U.S. FDA clearances for the Nerivio prescription wearable to include migraine prevention in individuals with or without aura. The remote electrical neuromodulation (REN) device offers an alternative to the significant population of migraine patients who do not respond to or cannot tolerate prescription drugs that treat the condition.
The U.S. FDA announced Feb. 27 that it is aware of data that suggest that the Trifecta surgical aortic valve replacement (SAVR) devices are potentially prone to early structural deterioration that could compromise both valve performance and valve durability.
GE Healthcare Technologies Inc. reported a recall of several systems in its nuclear medicine line of high-end imaging systems for two potential issues that could lead to the collapse of a detector weighing more than half a ton onto the patient. According to the U.S. FDA listing for the recall, no injuries or fatalities have been reported in connection with these issues, but the announcement resurrects an episode from 2013 in which a patient in New York lost his life when a nuclear imaging camera collapsed during an imaging procedure.
The U.S. FDA recently proposed a modest overhaul of the rules pertaining to radiological products and other categories of products in an effort to eliminate duplicative or obsolete rules, such as a requirement for triplicate reports for variances in system performance.
