In the current Cyber Threat environment, companies must have strong cyber liability insurance. Policies must specifically account for cyber-physical risks and the substantial costs of post-market remediation, including mandatory software patches and patient notifications. Insurers are well aware of the 524B mandate and are increasingly requiring proof of compliance before issuing coverage or offering favorable rates. How do you assure your cyber risk plan insurable?
A comprehensive update on the combination products market shows significant industry partnerships, development challenges, and strategic imperatives for success in the sector characterized by dynamic collaboration between pharmaceutical and device companies, rapid product development cycles, and complex regulatory landscapes.
Recor Medical Announces Paradise Ultrasound Renal Denervation System Receives Manufacturing and Marketing Approval in Japan for the Treatment of Resistant Hypertension.
Terumo Corporation is acquiring OrganOx Limited to enhance organ preservation technology and address transplant challenges globally. Acquisition marks Terumo entry into transplant sector.
While Zimmer has been able to maintain the largest market share over the past decade, competition in the knee reconstruction space is no longer limited to pricing or incremental design improvements. It is evolving into a battle of technological sophistication and long-term clinical outcomes.
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.
The companies have reached a long-term agreement allowing customers to use software, data, technology, and service offerings from Veeva and IQVIA together.
Over the past decade, global regulations for medical technology have skyrocketed from around 500 to over 8000. Navigating the complexities of regulatory compliance is a daunting task—especially when faced with orthogonal aspects of regulations.
The MedTech industry has seen significant growth and raised expectations as it adapts to evolving healthcare needs in the wake of the COVID-19 pandemic. The industry’s ability to make technology a part of everyday life will be key to driving growth and evolving with the demands of a disparate patient population.
