Most medtech companies can’t seamlessly exchange product information between in-country and global regulatory assurance teams, according to the 2023 Regulatory Benchmark Report from Veeva MedTech. Without a standardized and consistent way to share documents globally, organizations can’t ensure the reliability or accuracy of product information across markets. This increases compliance risk.
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The company announced that it will not sell new devices to treat sleep apnea in the United States in the coming years as it works to comply with a settlement with the Food and Drug Administration.
The Dutch medical devices maker started the recall process on Nov. 30 this year and has recalled 150 devices in the United States.
Some of the biggest trends in pharma will also be affecting the medtech industry next year.
Medical device makers are seeing higher demand for their products due to a steady recovery in surgical procedures that were deferred during the pandemic, especially by older adults, as well as easing staff shortages at hospitals.
GE HealthCare Technologies beat Wall Street expectations for third-quarter profit as a continued recovery in demand for surgical procedures boosted sales of its medical devices.
A steady recovery in surgical procedures that were deferred during the pandemic, especially by older adults, as well as easing staffing shortages at hospitals have increased demand for medical devices.
Thermo Fisher’s outlook cut is “more or less” expected and focus will now shift to how this will impact the company in 2024, according to one analyst.
The primary objective of the study is 180-day post-implantation survival without disabling stroke or successful heart transplant within 180 days of implantation, the company said.
