Device recalls increased 33 percent in 2011 because of FDA’s work to reduce a backlog of unclassified recalls, manufacturer concern about nonconforming products and the agency’s sharp focus on radiological device safety, among other explanations. “The elimination of the recall backlog in ORA and the center, as well as enhanced industry reporting, were big factors across all FDA-regulated products,” said Ann Ferriter, director of the Division of Risk Management Operations in CDRH’s Office of Compliance. And the center is continuing to improve: In the first quarter of FY 2012, it achieved an 80 percent on-time classification rate thanks to work by its “Recall Process Improvement Project,” which is due to wrap up by Oct. 31. In related news, Congress may consider legislation requiring FDA to establish a program to routinely assess recall information, and ORA is looking to beef up its recall audit check process.
Swifter FDA classification of medical device recalls, extra efforts by agency staff and an industry increasingly cautious about product problems contributed to a historically high number of recalls last year, experts say.
The agency “had a significant backlog of unclassified recalls, and we were able to reduce that backlog by more than 50 percent in 2011
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Medtronic announced it received expanded MRI labeling for its DBS systems, which is critical, given that almost 70% of all DBS-eligible patients will likely need an MRI at some point in their care, says Ashwini Sharan, CMO for Medtronic Neuromodulation.
In this episode, Medtech Insight reporter Natasha Barrow speaks to LungLife AI CEO Paul Pagano. Lung Life AI is a US-based AIM-listed medical technology company that has developed a liquid biopsy test for the early detection of lung cancer called Lung LB. Pagano runs through the highlights of Lung Life AI journey to date and its future ambition for a strategic partnership. He also provides advice to similar diagnostic companies seeking reimbursement andcompliance with the US FDA Lab Developed Test ruling.
While MedTech Europe sharpens its focus on what the EU most urgently needs to advance the medtech market in four targeted measures, the European Commission has also unveiled four priorities for 2025.
GE HealthCare anticipates most of the $0.85 EPS tariff impact will play out in the second half of 2025. Jay Saccaro, vice president and CFO, said the tariff-related burden is minimal in Q1 at about $10 million, rising to nearly $100 million in Q2 and then spiking to around $200 million each in Q3 and Q4.
Peerbridge Health is preparing to submit its next-generation ECG patch, CorMDx, for US FDA clearance this quarter, with plans to launch in the second half of 2025. The rechargeable device is designed for continuous, real-time heart monitoring from the hospital to home, aiming to detect early signs of heart failure and reduce emergency room visits.
