Abiomed Inc., has worked the ventricular assist device (VAD) space for a number of years with its Impella series of VADs, and a study coming out of Japan seems to affirm investors’ confidence in these devices. This registry study demonstrated that the combination of Impella devices and extracorporeal membrane oxygenation (ECMO) provides a 30-day survival rate of more than three in four patients with cardiogenic shock, an outcome that is said to support the notion that the native heart tissue can recover from myocarditis, an especially salient consideration for those who contracted the SARS-CoV-2 virus.
In an unexpected turn of events, Medtronic plc presented results from the Symplicity HTN-3 trial at year 3 showed sustained reductions in blood pressure with radiofrequency renal denervation (RDN) for resistant hypertension, contrary to the trial’s results at the six-month mark—and it wasn’t alone in showing positive results for the procedure.
Despite wide availability and coverage for colonoscopy, many patients diagnosed with colorectal cancer (CRC) have never undergone the recommended screening procedure for the malignancy and its precursors. As a result, the cancer has already spread in the majority of cases at the time of diagnosis. CRC remains the third most common cancer diagnosed in the U.S. and the second leading cause of cancer death for both men and women.
The casual observer may be inclined to think that the European Union’s Medical Device Regulation (MDR) is off to a rocky start, but those whose livelihoods are at stake have a more intimate view of the situation. An attendee at a Sept. 12 session at this year’s Regulatory Convergence lamented what she believes is a dismal outlook for EU patients and device makers in the coming year, a testimonial that drew cheers and applause from those in attendance.
U.S. FDA commissioner Robert Califf resurrected a litany of complaints about medical product misinformation, including vaccinations for the COVID-19 pandemic, in a televised presentation heard by attendees at the Regulatory Affairs Professional Society (RAPS) annual conference here in Phoenix, where the daytime high temperatures are hovering at or near the century mark.
Some of the most exciting news out of the European Society for Medical Oncology Congress 2022 in Paris surrounded the rapidly evolving field of multi-cancer early detection (MCED), which offers the dual benefits of identifying malignancies at a more easily treated local stage and enabling screening for the 70% of cancers that lack recommended screening tests.
Medical science has been experimenting with smart devices for several years to determine whether these products can detect circulatory system diseases, and a study presented at the 2022 meeting of the European Society of Cardiology (ESC 2022) seems to strongly suggest that the answer is a resounding yes. The eBRAVE-AF study of more than 5,500 enrollees of middle age or older demonstrated the ability of a smartphone camera and a downloadable app to at beat conventional screening for atrial fibrillation (AF), a finding that could save lives and boost the prospects of device makers in the digital health space.
Payers are known to have a significant burden in crafting coverage and reimbursement policies for in vitro diagnostics, but Gillian Hooker, chief scientific officer at Concert Genetics Inc., of Nashville, Tenn., told an audience at the Next Generation DX Summit that the dilemma may be more expensive than commonly appreciated. Hooker said administrative costs may add as much as $125 per administered test, an artifact of a fragmented value chain that seems to enjoy few, if any prospects of improvement in the near term.
Data on C2N Diagnostic LLC’s new blood test combining a proprietary p-tau217 measurement with the amyloid beta (a-beta) 42/40 ratio, a component of C2N’s commercially available PrecivityAD blood test, could help to predict people at risk for Alzheimer’s disease (AD) – even at the earliest stages.
Big pharma is increasingly turning to Taiwan to leverage the power of the country’s data and computing power as precision medicine takes center stage in drug development, speakers said during the recent BIO Asia-Taiwan conference in Taipei.