U.S. FDA inspections are not always a pleasant experience, particularly when the end result is a warning letter. One company, Sea-Long Medical Systems LLC of Waxahachie, Texas, says the experience was a positive experience in that the company’s new ownership gained an important appreciation for the necessary rigors of medical device manufacturing.
The U.S. House of Representatives has passed an agreement with the Biden administration on the debt ceiling, a deal that does not affect mandatory spending programs such as Medicare. However, the agreement, which still must gain the Senate’s stamp of approval, appears to eliminate any chance of yet more monies for the National Institutes of Health or the FDA, two programs of intense interest for companies in the life sciences.
In a new health technology assessment, the U.K. National Institute for Health and Care Excellence (NICE) has voiced misgivings about the evidence behind the use of MRI/ultrasound fusion systems to perform needle biopsy for suspected prostate cancer. NICE said the evidence for these systems could be bolstered by additional research comparing fusion biopsy to cognitive fusion-directed biopsy, suggesting that companies working in this space have a significant evidentiary lift in front of them.
Most enforcement activities in the U.S. related to physician participation in fraud deal with activities that run to six figures at most, but the U.S. Department of Justice (DOJ) reported recently that it has snared a much bigger fish.
The U.S. FDA has issued a final guidance for non-clinical performance testing for tissue containment bags used during power morcellation procedures, and the FDA had recommended in 2020 containment bags always be used during morcellation procedures. Despite the FDA’s advisory, a survey of surgeons published last year suggested that most of these procedures are not done with these containment systems, possibly because the rate of procedure-related complications is considerably higher when containment is used.
Boston Scientific Corp., has announced that it has abandoned its plans to acquire M.I. Tech Co. Ltd., of South Korea after opposition was announced by the U.S. Federal Trade Commission (FTC). The FTC lauded the news with a May 24 statement that cited the agency’s cooperation with other national regulatory authorities as a factor in scotching the proposed acquisition, the second time in recent weeks that government agencies have grounded mergers and acquisitions in the med-tech space.
Patent disputes over medical technology exert a significant influence on a company’s fortunes in the marketplace, and a recent decision by the U.S. Court of Appeals for the Federal Circuit reinforces yet again the importance of patent protection for device manufacturers. In a decision filed May 24, the Federal Circuit decreed that patents for catheters held by Teleflex Innovations were not rendered ineligible by what Dublin-based Medtronic plc had asserted was prior art, thus dealing Medtronic a blow in its efforts to have the five Teleflex patents in question rendered null.
Jewelry used to adorn the human ear is not the stuff of legend where medical technology is concerned, but a clip-type device, similar to an earring, that can be worn on the tragus of the ear might soon become daily wear for those who suffer from postural orthostatic tachycardia syndrome (POTS). Researchers at the University of Oklahoma say their self-administered clip can relieve POTS with just one hour’s use per day over a period of two months, a finding that might prove an inexpensive and convenient treatment for as many as one million Americans who currently have few treatment options.
Bringing both ventricles back into synchrony has long been the subject of cardiological hopes in patients with heart failure, but current approaches to maximizing the function of the left ventricle leave many patients in a desperate state of cardiac dyssynchrony. However, Ebr Systems Inc., has reported the results of a study that demonstrates that its WiSE device can pace the left ventricle in patients who are unresponsive to conventional pacing in an effort to restore optimal left ventricular function, a development Sunnyvale, Calif.-based Ebr says will allow the company to conclude a premarket filing with the U.S. FDA.
Pulsed field ablation (PFA) seems to have seized the moment in the field of cardiac electrophysiology, given its seemingly superior performance over other ablation modalities as a treatment for atrial fibrillation (AF). New data from three studies were presented at this year’s annual meeting of the Heart Rhythm Society that further confirm the value of PFA as a treatment for both persistent and paroxysmal AF with data sets that seem to confirm that PFA is poised to sweep aside the current standards for ablation, potentially overturning a treatment paradigm that took decades to establish.
