Medical Devices
The latest report from the Productivity Commission notes the "slow" uptake of remote care technologies despite wide availability.
New partnerships with Mayo Clinic and Memorial Hermann Health Systems will bring Zipline's autonomous home-delivery service to Houston, Jacksonville and Rochester, Minnesota.
Despite the highest agency user fees on record, and granted new authorities to reform and accelerate medical device and biologics approvals, representatives questioned delays in getting products to patients faster.
Also, IHH Healthcare is now offering AI-based sleep monitoring solutions.
The Advanced Research Projects Agency for Health, ARPA-H, seeks to scale hospitals' cybersecurity capacity by automating patch deployments across networks and medical devices, speeding the time from vulnerability detection to software updates.
The company's Dream Sock, which received FDA 510(k) clearance in November, gathers real-time health readings, including a baby's sleep trends and pulse rate.
The Agency has qualified Apple's atrial fibrillation history feature as a medical device development tool, allowing it to be used in clinical trials.
To improve healthcare cybersecurity, an organization can shore up Internet-enabled device misconfigurations by starting with CIS Benchmarks, before moving on to industry-specific standards, Fortra’s Tyler Reguly said.
Also: CloudWave and FDA extend their threat intelligence partnership to offer an open-source vendor assessment framework.
The agency further defines when it considers a device to be Internet-enabled, proposes to add vulnerability disclosures and makes recommendations for cyber device maintenance plans and patch timelines.
