Amulet vs Watchman Comparison Still Muddy Any Which Way LAA Leaks Are Defined
SAN FRANCISCO — Two mainstream devices for percutaneous left atrial appendage (LAA) closure continued to lead to similar clinical outcomes in the SWISS-APERO trial. Among patients randomized to the Amplatzer Amulet and the Watchman 2.5/FLX, the incidence of patent LAAs at 13 months reached 53.6% and 48.8%, respectively, on coronary CT angiography (risk ratio [RR] […]
CMS Must Work Harder to Get New Drugs and Devices Covered Quickly, House Members Say
Medicare needs to up its game when it comes to approving coverage for new drugs and devices, witnesses and members of Congress agreed Tuesday at a House hearing. “Despite the historic advancements in treatments for Alzheimer’s disease, the Biden administration has decided to limit access to these therapies through onerous coverage policies that require patients […]
FDA Faults Next-Gen Olympus Duodenoscopes
If you thought the introduction of single-use duodenoscope components had made these devices safe, the FDA has some unwelcome news for you. The agency recently sent a warning letter to Olympus Medical Systems, one of the top duodenoscope manufacturers, upbraiding the company for its sluggish response to a slew of complaints about parts coming off […]
Genetic Testing for Opioid Use Disorder Heads to FDA Advisors
On Thursday, members of the FDA’s Clinical Chemistry and Clinical Toxicology Devices Advisory Committee will meet to discuss AvertD, a prescription genetic risk assessment tool for opioid use disorder (OUD). AvertD detects the presence or absence of 15 single nucleotide polymorphisms (SNPs) to help identify adults with an increased genetic risk of OUD. It’s intended […]
Are Skin Lesion Analyzers Ready for Prime Time?
While the FDA is proposing to reclassify two class III computer-aided melanoma detection devices as class II devices, most members of its General and Plastic Surgery Devices Panel suggested that such a move would be premature during the Medical Devices Advisory Committee meeting on Friday. According to the FDA, reclassification of the MelaFind and Nevisense […]
Paclitaxel Devices Safe in PAD In Medicare Data Beyond 3 Years
ATLANTA — Paclitaxel-coated devices for femoropopliteal artery revascularization were not associated with any excess mortality risk in the latest update from Medicare data. The risk of death from any cause, if anything, trended slightly lower (hazard ratio 0.98, 95% CI 0.96-0.99) with paclitaxel-eluting stents or -coated balloons compared with bare metal stent or percutaneous transluminal […]
‘E-nose’ could someday diagnose Parkinson’s disease by ‘smelling’ skin
Scientists have been trying to build devices that could diagnose Parkinson’s disease (PD) through odor compounds on the skin. Now, researchers reporting in ACS Omega have developed a portable, artificially intelligent olfactory system, or “e-nose,” that could someday diagnose the disease in a doctor’s office. PD causes motor symptoms, such as tremors, rigidity and trouble […]
FDA Warns on Needle-Free Injection Devices for Facial Fillers
The FDA issued a safety alert on Friday warning against the use of needle-free injection devices for lip or facial fillers — such as hyaluron pens for injecting hyaluronic acid — as these devices are unapproved and have been linked with serious injuries. Patients “may not be aware of the serious adverse events that have […]