Regulation
The t:slim X2 Pump is compatible with Dexcom G7 and G6 continuous glucose monitoring systems and was cleared for sale by Health Canada.
Healthcare attorney and partner at Holland & Knight Zubin Khambatta discusses the CMS final rule related to Medicaid managed care and its provisions adding new compliance guardrails regarding state-directed payments.
HIMSS24
Gaurav Sharma, market innovator and global client partner at Cognizant, discusses the balance between accelerating healthcare's use of technology with putting regulations in place to protect patients.
LifeSemantics plans to commercialise its mobile app-based AI screening solution by yearend.
The ONC's new rules could include advancements around public health IT certification requirements, electronic prior authorization, patient engagement tools and refinement to info blocking rules, says Sean Sullivan, a partner at Alston & Bird.
Carolyn Metnick, partner and Healthcare and Privacy & Cybersecurity team member at Sheppard Mullin, recommends that healthcare organizations follow basics such as following HIPAA security rule compliance and doing a security risk analysis.
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.
The Agency alleges the company's CT and ultrasonography systems are noncompliant with good manufacturing requirements.
They had been designated as innovative medical devices.