Healthcare industry stakeholders say the FDA should consider a type of measuring stick when evaluating a vendor’s cybersecurity culture to decide whether it meets the requirements for the agency’s proposed fast-past program for premarket approval of "software as a medical device" products (SaMD). Until the end of the last month, the FDA accepted proposals on its working model for a SaMD pre-approval program
It has been reported that the FDA has granted the approval of Mobius Imaging, LLC based Airo CT imaging utilization for pediatric patients. These pediatric patients can receive the clinical benefits of Airo CT imaging for diagnostic and intraoperative procedures hereafter.
This will be the second recall on a heart device this month Medtronic’s Heartware device and accessories was recalled a few days ago. This comes after Abbott issued a patch to negate cybersecurity issues 350,000 remote monitoring systems and pacemakers.
Niti Aayog is focusing on proposals to encourage domestic manufacturing of medical devices following orders from the Prime Minister's Office, said the expert. The meeting was focused on identifying the problems in local manufacturing and quality of the devices produced in India and also to spot the solution for the issues.
The global ultrasounds systems marker is expected to clock a market value in excess of over USD 12,500 million by the end of 2028, recording a CAGR of 5.7% in the forecast period as per findings of global forecasts stated in the report titled 'Ultrasound Systems Market - Global Industry Analysis 2013 - 2017 and Opportunity Assessment 2018 - 2028'.
Holland-based Genesis Innovation Group LLC raised $7.2 million of its $10 million goal toward a fund to invest in early-stage healthcare companies developing medical devices and orthopedic technologies.
The implementation of privacy protocols and security controls is pertinent to protecting patient records and sensitive data. However, the threat to patient safety, the core of every modern health system, being compromised is growing rapidly owing to network-connected medical devices.
Scientists from the Department of Chemistry at Imperial have developed a small, user-friendly, accurate and cost-effective sensor to test arsenic levels in drinking water within a minute. When a drop of water hits the test strip, it gives the arsenic level count digitally.
your submission has already been received.
Please enter a valid Email address！
The most relevant industry news & insight will be sent to you every two weeks.