Technology | PET Imaging | December 05, 2018

Subtle Medical Receives FDA Clearance, CE Mark for SubtlePET

Artificial intelligence-based technology allows faster PET scans while enhancing image quality

Subtle Medical Receives FDA Clearance, CE Mark for SubtlePET

December 5, 2018 — Subtle Medical announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market SubtlePET. Subtle Medical also recently secured approval to affix the CE Mark on SubtlePET to begin marketing in the European Economic Area without restrictions.

SubtlePET’s artificial intelligence (AI)-powered technology allows hospitals and imaging centers to enhance images from faster positron emission tomography (PET) scans, leading to an improved patient experience during nuclear imaging procedures, while boosting exam throughput and provider profitability. SubtlePET is currently in pilot clinical use in multiple university hospitals and imaging centers in the U.S. and abroad.

“Focusing Subtle Medical's SubtlePET AI platform on faster image acquisition, we have been able to dramatically increase PET scan efficiency and provide a superior patient experience. SubtlePET  technology allows us to scan a patient four times faster than normal, yet maintain equal image quality, not otherwise impacting work flow,” said Michael Brant-Zawadzki, M.D., FACR, Hoag Hospital, Newport Beach, Calif. “This creates immediate ROI [return on investment] benefit for our hospital and a compelling value proposition. I’m looking forward to seeing more groundbreaking technology from the Subtle team.”

Subtle Medical’s AI solution:

  • Enables completion of more exams in a day compared to conventional PET imaging without the need for capital expenditures;

  • Reduces patient time in the scanner; and

  • Helps hospitals and imaging centers enhance their bottom line in today’s competitive healthcare environment.  

The company’s technology utilizes deep learning algorithms that integrate seamlessly with any OEM scanner and picture archiving and communication system (PACS) to enhance images during acquisition, without any interruption or alteration in the imaging specialists’ workflow.  SubtlePET delivers a significant improvement in the image quality of noisy images resulting from shorter scans, which is particularly beneficial for children and those undergoing repeat PET exams.

SubtlePET is the first product in Subtle Medical’s growing portfolio of new AI technologies to receive FDA clearance. The company is developing additional products to be submitted for FDA clearance.  A second product currently undergoing clinical evaluation is SubtleMR, which allows imaging centers to significantly accelerate magnetic resonance imaging (MRI) scans using the company’s AI solutions. SubtleGAD is also being developed to reduce gadolinium dosage during imaging procedures.

For more information: www.subtlemedical.com

Related Content

News | Artificial Intelligence

September 27, 2021 — Zebra Medical Vision, the deep-learning medical imaging analytics company, announces its eighth U.S ...

Home September 27, 2021
Home
Feature | Artificial Intelligence | By Dave Fornell, Editor

Artificial intelligence (AI) is growing in all areas of medicine and was the topic of several advanced technology ...

Home September 08, 2021
Home
Webinar | Artificial Intelligence

Artificial intelligence is becoming best practice to support clinical decisions and help standardize echocardiography ...

Home August 12, 2021
Home
News | Artificial Intelligence

July 21, 2021 — Artificial intelligence (AI) medical imaging vendors Viz.AI and Avicenna.AI have partnered to enable ...

Home July 21, 2021
Home
Videos | Artificial Intelligence

Federico Asch, M.D., FASE, director of cardiovascular core labs, cardiovascular imaging, MedStar Health Research ...

Home July 01, 2021
Home
News | Artificial Intelligence

June 28, 2021 — Circle Cardiovascular Imaging Inc. and DiA Imaging Analysis Ltd. entered into a multi-year partnership ...

Home June 28, 2021
Home
News | Artificial Intelligence

June 25, 2021 – COVID-19 changed everything in healthcare, and a benefit from this pandemic was a surge in innovations ...

Home June 25, 2021
Home
Feature | Artificial Intelligence

The digital transformation of healthcare is underway, but it will advance further and faster if key stakeholders work ...

Home June 10, 2021
Home
News | Artificial Intelligence

June 9, 2021 — AI Med will present its Virtual Clinical Series: Imaging Built by Clinicians, for Clinicians, June 29-30 ...

Home June 09, 2021
Home
News | Artificial Intelligence

June 3, 2021 — Medical imaging AI specialist Avicenna.AI announced that it has received certification in the United ...

Home June 07, 2021
Home
Subscribe Now