Penumbra Inc. continues its push into peripheral therapies with the recent US introduction of the POD Packing Coil, designed to occlude arteries and veins in conjunction with the company's Ruby and POD (Penumbra Occlusion Device) embolization products for the treatment of peripheral vascular conditions such as aneurysms and fistulas. The POD Packing coil, which earned a 510(k) in 2015 along with a neurovascular version of the device, grew out of the platinum coil technologies used to treat brain aneurysm.
Penumbra Inc. has begun its first major product launch since going public in September, with the US introduction of the POD Packing Coil, designed to be used with the Ruby and POD embolization coils, the San Francisco company announced Jan. 6.
The POD Packing coil, which earned a 510(k) in 2015 along with a neurovascular version of the device, is specifically designed to pack very densely behind the Ruby or POD...
The FDA has stopped accepting data from two Chinese labs due to accuracy issues. Mid-Link and SDWH have been flagged for potentially falsified results and other misconduct. This decision, which follows months of discussions and warnings, emphasizes the FDA's commitment to ensuring data integrity in medical device submissions.
TRiCares presented data from the first-in-human study for its tricuspid valve replacement system – Topaz – at EuroPCR 2025 on 22 May.
Guardant Health introduces a new germline panel test to help guide cancer treatment, assess the risk of secondary cancers in patients and identify family members at risk of cancer.
Fujirebio Diagnostics' Alzheimer's disease test, Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, has been cleared by the US FDA.
The consumer genomics firm will operate as a subsidiary, while Regeneron plans to leverage its database for drug discovery and trial design efforts.
FemTech leaders discussed some of the barriers that remain in unlocking the full potential of the women’s health market during SiS New York last week. They also offered solutions.
A battle may be forming over the 2027 FDA user fee reauthorizations. At a conference Friday, Democratic Rep. Jake Auchincloss supports them for their effectiveness, while Deputy FDA Commissioner Grace Graham echoed criticisms from HHS Sec. Kennedy, among others, in calling for reform to ensure public trust.
