The markets for ventricular assist devices (VADs) and intraortic balloon pumps (IABPs) are hardly littered with competition, but the few companies that work in these two device categories have faced seemingly routine recalls over the past couple of years. The U.S. FDA recently reported yet another round of class I recalls for a single model in both Abiomed Inc.’s Impella line of VADs and Datascope Corp.’s Cardiosave line of IABPs, but the agency’s apparent unwillingness to force either manufacturer to withdraw any of these recalled products seems to suggest that product shortages would quickly follow any such move on the FDA’s part.
Recruitment underway for Toronto-based Vielight Inc. has commenced recruitment for a clinical trial in the U.S. to study how brain stimulation photobiomodulation (PBM) might mitigate long-term cognitive impairment from long Covid. The study intervention comes on the heels of Canadian approval of a device to treat the acute version of Covid, involving light emitting diodes (LEDs) placed inside the nasal cavity and on the chest to deliver near infrared (NIR) light to the body.
U.S. federal preemption of state liability law for medical devices is firmly established for PMA devices, but this is not the case for devices that are cleared via the U.S. FDA‘s 510(k) program. However, some courts have gone a step further in disallowing defendants in product liability litigation from entering evidence of 510(k) clearances from the FDA, a practice that played a role in a $3.3 million verdict against Murray Hill, N.J.-based C.R. Bard Inc. that the U.S. Court of Appeals for the Seventh Circuit decreed is not eligible for a new trial.
Some U.S. FDA inspections go better than other ones, but the agency’s inspection of the Boston plant operated by a subsidiary of Princeton, N.J.-based Integra Lifesiences Holding Corp. was not one of those with a quick resolution. The agency said in a July 17 warning letter that Integra will have to obtain certification for the site in each of the next three years after finding considerable fault with operations, including one citation the agency said is a carryover from a warning letter issued in 2019.
Cathvision ApS received U.S. FDA clearance for two artificial intelligence (AI) models, the PVI Analyzer, and Signal Complexity, which are part of a suite of algorithms designed to help electrophysiologists improve the diagnosis and treatment of complex atrial arrhythmias, including atrial fibrillation. The two algorithms are part of Cathvision’s Cardialytics suite of AI-powered analytics integrated into its Ecgenius system, an electrophysiology recording system that helps with electrogram interpretation.
The U.S. FDA granted the de novo marketing request for Bluewind Medical Ltd.’s Revi system for the treatment of urgency incontinence with or without urinary urgency, the company reported on August 17. Unlike other neuromodulation devices approved in recent years, Revi stimulates the tibial nerve instead of the sacral nerves.
It’s been 25 years since the U.S. FDA issued a final guidance on informed consent and nine years since it asked for comments on a draft guidance to supersede that 1998 guide.
Fractyl Health Inc. reported clinical updates on the Revita real world registry in Germany which has demonstrated clinical remission from type 2 diabetes (T2D) employing a device that resurfaces the duodenal mucosa, the innermost layer of the first portion of the small intestine, and a potential root cause of T2D.
Hypertrophic cardiomyopathy (HCM) might not be the talk of the town in the world of cardiology medical devices, but the condition has a devastating effect on a large number of lives, particularly in the case of early disease onset. San Francisco-based Viz.ai Inc. has won a de novo from the U.S. FDA for its algorithm for identification of patients at risk of HCM, the aptly named Viz HCM, a product the company believes will not only save lives but may save the U.S. health care system a large amount of money as well.
Bruker Corp. signed a definitive agreement to acquire functional cell biology company Phenomex for $108 million as part of its Project Accelerate 2.0 strategy, which increases focus on the company’s emerging proteomics and spatial biology business. Bruker offered $1 per share, a 150% premium over the 40 cents per share closing price of Phenomex stock on Aug. 16. The all-cash transaction is slated to close in the fourth quarter of 2023.
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