FDA News

Portable scanning device to rule out MI cleared by FDA

Creavo Medical Technologies announced the FDA cleared its portable scanning device designed to rule out ischemic heart disease in patients presenting with chest pain.

According to a press release from the company, the portable scanning device (Vitalscan) uses magnetocardiography to perform noninvasive bedside scans in 3 to 5 minutes, helping to accurately rule out ischemic heart disease and expedite the process to finding the most appropriate care pathway.

The company also announced that as a result of the clearance, it will conduct several clinical trials in U.S. centers. A multicenter trial is ongoing in the United Kingdom.

“This is a major development and brings us closer to realizing our overriding objective—to improve patient care and save time and resources for hospitals,” Steve Parker, CEO of the company, said in the release.

Disclosure: Parker is an employee of Creavo Medical Technologies.

Creavo Medical Technologies announced the FDA cleared its portable scanning device designed to rule out ischemic heart disease in patients presenting with chest pain.

According to a press release from the company, the portable scanning device (Vitalscan) uses magnetocardiography to perform noninvasive bedside scans in 3 to 5 minutes, helping to accurately rule out ischemic heart disease and expedite the process to finding the most appropriate care pathway.

The company also announced that as a result of the clearance, it will conduct several clinical trials in U.S. centers. A multicenter trial is ongoing in the United Kingdom.

“This is a major development and brings us closer to realizing our overriding objective—to improve patient care and save time and resources for hospitals,” Steve Parker, CEO of the company, said in the release.

Disclosure: Parker is an employee of Creavo Medical Technologies.

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