Originally CE marked in 2021 for limited to high-risk patients only, .Abbott has now received CE mark approval for its Navitor transcatheter aortic valve replacement (TAVR) system to treat low- and intermediate-risk patients with symptomatic, severe aortic stenosis.
The company initiated trials for AGENT DCB, a drug-coated coronary balloon approved for use in the U.S. and currently indicated to treat coronary in-stent restenosis (ISR) in patients with coronary artery disease.
According to Company, the patent has profound business implications for Inspira and for its ability to dominate a market with a potential size of $20 billion.
As these regulations continue to change, MedTech companies need to leverage the right systems to streamline processes, ensure continuous compliance, and mitigate the risks associated with non-compliance
Medical Devices must be fully reimbursable – no out of pocket expenses – in Japan. So, how is reimbursement achieved for your medical device?
Under IVDR, clear and specific IVD intended use criteria are required and introduce significant challenges for manufacturers seeking CE Marking and global market access. With updated compliance deadlines approaching, how can manufacturers manage risk and avoid regulatory delays and disruptions in their market strategies?
Clear and specific IVD intended use criteria are required and introduce significant challenges for manufacturers seeking CE Marking and global market access. With IVDR compliance deadlines approaching, how can manufacturers manage risk and avoid regulatory delays and disruptions in their market strategies?
Medical Device reimbursement levels in Japan are now more in line with the reimbursement levels in the EU. The Japanese government has pledged not to allow Japanese device reimbursement to be as high as the US prices.
An analysis from the Life Sciences legal team at Hogan Lovells.
Predicting the potential of cell and gene therapy pipelines presents unique challenges. Following are considerations for forecasters working with novel technologies.
