Kestra Medical Inc. seems to have put itself in a position to take a bite out of the market for wearable defibrillators with the results of the ASSURE WCD study, which enrolled more than 21,600 patients. The study, whose results were reported on at the American Heart Association annual meeting in New Orleans, demonstrated that Kestra’s unit delivered an inappropriate shock rate of only 0.0065 per patient per month, an outcome that analysts at Wells Fargo said will allow Kestra to close the gap on competitors such as Zoll Medical.
On Nov. 5, the Chinese Ministry of Commerce reported it would lift the export ban on Illumina Inc., which had been in place since March 4. While the ban will be lifted starting Nov. 10, Illumina remains on the unreliable entities list, requiring government approval for instrument purchases.
Impulse Dynamics Inc. snared an affirmative Medicare coverage policy for its Optimizer cardiac contractility modulation (CCM) system, giving the company sole possession of the U.S. marketplace for this therapy at least for the time being.
Results of the Shortcut study, presented last week at the Transcatheter Cardiovascular Therapeutics meeting in San Francisco, indicated that cutting balloon angioplasty matched intravascular lithotripsy in coronary artery preparation of calcification for stent placement.
Two in five preclinical studies on subarachnoid hemorrhage (SAH) published in peer-reviewed scientific journals contain problematic images. A team of researchers from Radboud University Medical Center, who had previously identified several such cases, analyzed the literature in this field to assess the scope of the issue. They found that 40% of the studies included suspicious images.
Sparrow Acoustics Inc., dba Sparrow Bioacoustics Inc., closed a C$10 million (US$7.15 million) financing round to support continued adoption of its U.S. FDA-cleared Stethophone platform, which allows bioacoustics detection of structural and rhythmic heart anomalies directly through a smartphone. Sparrow is a Software as a Medical Device and the first medically cleared product that uses smartphones to capture and decipher cardiac sounds.
The prevalence of valvular heart disease in the U.S. is tough to peg with any great precision, but an extrapolation of data from a new study would put the number at roughly 10.6 million people, a staggering number when the clinical and fiscal implications are considered.
Stakeholders of all stripes have wondered whether transcatheter aortic valve replacement devices could match their surgically implanted cousins for device durability, but seven-year data from the Partner 3 trial seems to suggest that patients, physicians, payers and regulators need not fret as the topline numbers showed no statistically significant difference for outcomes such as mortality and morbidity.
Medtronic plc’s SPYRAL HTN-ON MED trial demonstrated significantly greater reduction in blood pressure with the Symplicity Spyral renal denervation procedure at three years than a sham procedure in a study presented as featured clinical research at the 2025 Transcatheter Cardiovascular Therapeutics conference in San Francisco.
Cordis Corp. has quite a bit to crow about in this latter part of October 2025 with the unveiling of results of two studies that back the Miami Lakes, Fla.-based company’s Selution SLR drug-eluting balloon (DEB) for both de novo coronary artery stenosis and in-stent restenosis.