Laws & Regulations

Olympus PolyLoop Device Faces FDA Class I Recall Over Injuries
Regulatory & Compliance Olympus PolyLoop Device Faces FDA Class I Recall Over Injuries

Setting the Stage for a Critical Medical Device Concern Imagine a routine endoscopic procedure turning into a life-altering ordeal due to a malfunctioning device. This scenario has become a stark reality for over a hundred patients affected by Olympus' PolyLoop ligation loop device, designed to

Lawmakers Propose Medicare AI Reimbursement Pathway
Regulatory & Compliance Lawmakers Propose Medicare AI Reimbursement Pathway

Setting the Stage for AI in Healthcare Funding Imagine a healthcare landscape where cutting-edge artificial intelligence tools, capable of detecting diseases with unprecedented accuracy, remain on the sidelines due to financial uncertainty. This is the reality facing many providers and innovators

Medicare Overpayments for Glucose Monitors Spark Concern
Regulatory & Compliance Medicare Overpayments for Glucose Monitors Spark Concern

Imagine a system meant to support millions of vulnerable patients, yet it’s shelling out hundreds of millions more than necessary on a single type of medical device. That’s the reality facing Medicare with continuous glucose monitors (CGMs), critical tools for diabetes management, where

Why Is HHS Firing and Rehiring Hundreds of Essential Staff?
Regulatory & Compliance Why Is HHS Firing and Rehiring Hundreds of Essential Staff?

From shutdown shock to whiplash rehires: setting the stage What looked like routine shutdown turbulence turned into a case study in whiplash staffing, as 954 laid-off Health and Human Services employees were reinstated with back pay by Nov. 21 following testimony from Thomas Nagy Jr. that confirmed

Can Medicare’s 2027 Drug Deals Save $12B—And What’s Next?
Regulatory & Compliance Can Medicare’s 2027 Drug Deals Save $12B—And What’s Next?

The IRA’s negotiation era comes into focus: why the 2027 price list matters now Sudden, double-digit cuts to high-spend drugs concentrate attention fast, and the newly finalized 2027 Medicare prices did exactly that by signaling roughly $12 billion in backcast savings if applied to 2024 use and an

Can Ceribell’s Neonatal Clearance Rewrite NICU Seizure Care?
Regulatory & Compliance Can Ceribell’s Neonatal Clearance Rewrite NICU Seizure Care?

James Maitland has spent his career stitching together robotics, sensors, and cloud intelligence to solve real problems at the bedside. That blend of hands‑on engineering and clinical pragmatism shows up in how he talks about seizure detection for the most fragile patients—newborns, including

Loading

Subscribe to our weekly news digest.

Join now and become a part of our fast-growing community.

Invalid Email Address
Thanks for Subscribing!
We'll be sending you our best soon!
Something went wrong, please try again later