Digital Transformation

This evolution of healthcare involves using technology to improve diagnosis, treatments, monitor patients, enhance hospital operations and culture, and bolster consumer-focused care. This includes virtual reality tools, wearable devices, workflow software, health apps and other digital health tools.

Spacelabs gets twin OKs from FDA

Spacelabs has been cleared to sell two new products in the U.S., an anesthesia system and a compact patient monitor.

Troubled Pennsylvania hospital gets shut down

A 67-bed, 129-year-old hospital in northeastern Pennsylvania has been effectively shut down by that states health department, its patients transported to other facilities, after officials discovered serious deficiencies and regulatory violations.

GE's Clarient expands with SeqWright purchase

GE Healthcare has acquired SeqWright, a developer of nucleic acid sequencing and other genomic services, to add complementary genomics capabilities to Clarient, a unit of GE Healthcare in the molecular diagnostics sector.

Heart Rhythm: Some Riata deaths linked to high-voltage failures

High-voltage failures in Riata and Riata ST implantable cardioverter-defibrillator leads and not externalized conductors may be the culprit behind deaths in some patients who received the devices, according to a study published online March 26 in Heart Rhythm.

GAO confirms basis for industrys frustration with FDA

Coming from Congress independent, nonpartisan Government Accountability Office (GAO), the title says it all: FDA Has Met Most Performance Goals but Device Reviews Are Taking Longer.

Integra 510(k)-cleared to sell take-apart laparoscopy gear

Plainsboro, N.J.-based Integra LifeSciences has received the governments blessing to sell a new line of easily disassembled laparoscopic instruments.

Radiology: Success requires rads to provide information, not just read images

To succeed in the future, radiology practices need to transition to a new model characterized by an information mindset with a greatly enhanced radiology product, according to a special report published in the April issue of Radiology.

Zoll X Series monitor/defibrillator cleared for EMS market

The FDA has given the 510(k) nod to Zolls monitor/defibrillator designed for emergency medical services, the X Series.

Around the web

The American College of Cardiology has shared its perspective on new CMS payment policies, highlighting revenue concerns while providing key details for cardiologists and other cardiology professionals. 

As debate simmers over how best to regulate AI, experts continue to offer guidance on where to start, how to proceed and what to emphasize. A new resource models its recommendations on what its authors call the “SETO Loop.”

FDA Commissioner Robert Califf, MD, said the clinical community needs to combat health misinformation at a grassroots level. He warned that patients are immersed in a "sea of misinformation without a compass."

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