A PMA for the PneumRx ELEVAIR endobronchial coil system will be considered by a US FDA advisory panel in June, but there will likely be some questions about the data.
US FDA's Anesthesiology and Respiratory Therapy Devices Panel will consider a first-of-a-kind implantable lung reduction coil for emphysema on June 14.
The agency scheduled the panel to consider BTG PLC’s PMA for the PneumRx ELEVAIR endobronchial coil system. It's intended...
Medicare beneficiaries with tricuspid regurgitation will now have access to an innovative treatment from Abbott that offers a minimally invasive alternative to open-heart surgery.
Research recently published in JAMA Internal Medicine found that the FDA met its review timeline goals for the majority of breakthrough devices – but also revealed some apparent shortcomings in safety data supporting the submissions.
The FDA's new Commissioner’s National Priority Voucher program aims to expedite drug approvals significantly. Device firms like XVIVO advocate for a similar initiative for devices, emphasizing the potential for faster reviews and improved patient access to lifesaving technologies.
A recent approval from the US FDA allowing Boston Scientific to broaden its labeling for its pulse field ablation system means more patients with one type of AFib will have access to a promising new treatment.
A recent FDA warning letter claims a Boston firm that specializes in wearable technology marketed a blood pressure device without agency approval. The company rejects the assertion and says the agency is out of step with federal law.
US Medicare has proposed national coverage of renal denervation for patients with uncontrolled hypertension. The treatment is seeing other advances as well, with Medtronic piloting a longer catheter and a multi-organ approach and a blood test to identify the best candidates fresh on the
The US House of Representatives passes legislation requiring manufacturers of non-flushable wet wipes to label products as ‘non-flushable," a move endorsed by the Personal Care Products Council.
