The COVID-19 pandemic pushed digital health to the forefront of care delivery, spurring massive innovation and investment. As the capital markets cool, investors are looking for companies with a proven return on investment, customer retention and good market fit.
The FDA announced that on October 1, 2023, it would begin to Refuse to Accept (RTA) medical device premarket submissions that do not comply with PATCH Act requirements. Erez Kaminski, former head of AI with Amgen and founder of Ketryx, and Paul Jones, former FDA official and Executive Vice President of Ketryx, provide an overview of challenges companies face as they work to comply with the new cybersecurity regulations and standards.
Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions provides recommendations on what information to include in premarket submissions and emphasizes that cybersecurity is a component of quality system regulation.
Recent developments, specifically artificial intelligence and the ubiquity of smart devices, enable us to monitor cough unobtrusively and continuously for periods of time. Objective cough quantification can be combined with patients’ perceptions to better determine diagnosis, treatment response and prognosis.
For life sciences companies seeking to develop, deploy and successfully commercialize digital health products and solutions, the pathway to success can have many twists, turns and roadblocks. This article examines some of the major challenges to bringing digital health products to market and explores potential opportunities to ease the journey.
Augmented reality (AR), with the help of artificial intelligence (AI), is providing healthcare professionals with the means to offer patients an unprecedented level of care and personalized treatments, and assisting MedTech and life sciences companies in product design and development. Yet, the potential of AR with AI in health care is still far from fully explored.
While the road ahead might be unpredictable, the core dynamics of the life sciences sector and the coming expiry of patents worth over $100 billion are poised to drive a renaissance in biotech mergers and acquisitions.
The Get Well platform is used at more than 70 Veteran Affairs Medical Centers (VAMCs). Now that it is listed on the FedRAMP Marketplace, the Get Well digital patient engagement platform can be contracted by any government agency without additional security vetting required.
“This cutting-edge technology empowers us with the ability to navigate complex vascular procedures with greater precision, ensuring optimal outcomes for our patients. We are honored to be a part of this innovative program.”
For “Systematic Testing of a Ventilator Remote Control System Towards Safe Use in Tele-Critical Care and Prolonged Care,” researchers developed a prototype system for network-based far remote-control of the NKV-550 critical care ventilator, with the goals of identifying and implementing foundational remote-control capabilities, and exploring essential performance, interoperability, and cybersecurity requirements.
