FDA clearances

Bedside MRI

Hyperfine Research Inc. received U.S. Food and Drug Administration (FDA) 510(k) clearance for its bedside magnetic resonance imaging (MRI) system, clearing the way for device shipments this summer. The Hyperfine system costs 20x less, consumes 35x less power, and weighs 10x less than today’s fixed conventional MRI systems.

The Hyperfine point-of-care device innovates on MRI design, architecture, and workflow, with more than 100 patents issued or currently pending. The portable system wheels directly to the patient’s bedside, plugs into a standard electrical wall outlet, and is controlled via a wireless tablet. It addresses limitations of current systems to make MRIs more accessible.

RF microneedling device

Cynosure’s Potenza radiofrequency (RF) microneedling device received FDA approval. The Potenza device’s four modes (monopolar or bipolar, delivered at either 1MHz or 2MHz) offer more customized microneedling treatments for patients, allowing practitioners to deliver shallow and deep treatments from a single system. The device’s monopolar RF mode delivers energy across a large area of tissue for deep heating and skin tightening through soft tissue coagulation. The bipolar RF mode offers more concentrated delivery of energy to treat superficial tissue. The device is equipped with Tiger Tip technology to allow practitioners to expand the treatment zone and address more tissue per treatment.

Heart and lung support system

Fresenius Medical Care North America’s (FMCNA) Novalung heart and lung support system for treating acute respiratory or cardiopulmonary failure has received FDA clearance. Novalung’s extracorporeal membrane oxygenation (ECMO) system is cleared for more than six hours of use as extracorporeal life support.

The Novalung ECMO system pumps and oxygenates a patient’s blood, reducing stress on damaged organs. Additionally, Novalung offers an alternative for invasive mechanical ventilation, which can cause additional lung injury from the required air pressure.