FDA clearances

DUO smart heart monitor OK

Eko Devices’ DUO – a combined digital stethoscope and electrocardiogram (ECG) has received U.S. Food and Drug Administration (FDA) clearance for marketing.

The portable cardiac device, inspired by cardiologists’ demand for more effective monitoring tools for heart disease, combines an ECG and digital stethoscope technology into a compact, handheld device for insight into cardiac function. Clinicians will use DUO as a screening tool or prescribe it to heart disease outpatients for use in at-home health kits. The device pairs with Eko’s secure, HIPAA-compliant app wirelessly, enabling remote monitoring and diagnosis by a clinician or specialist.

www.ekodevices.com

Pediatric approval for O3 regional oximetry

Masimo received FDA clearance for the pediatric indication for O3 regional oximetry with the O3 pediatric sensor. Regional oximetry may help clinicians monitor cerebral oxygenation in situations in which peripheral pulse oximetry may not be fully indicative of oxygen in the brain.

The regional oximetry monitoring sensor was already available for adults, but is now also available for pediatric patients weighing more than 5kg (11 lb) and less than 40kg (88 lb).

“Masimo O3 should help clinicians build a better picture of brain oxygenation – and hopefully better outcomes for all of their patients, including pediatrics as young as three-months old,” says Masimo founder and CEO Joe Kiani.

www.masimo.com

Advanced robotic-assisted surgery technology

Intuitive Surgical’s da Vinci X Surgical System received FDA 510(k) clearance in the U.S., allowing the company to provide robot-assisted surgical technology, programs, and services to an expanded market.

“This new system enables access to Intuitive’s leading and proven robotic-assisted surgical technology at a lower price point,” says Intuitive Surgical CEO Dr. Gary Guthart. “Customers around the globe have different needs from a clinical, cost, and technology perspective. Intuitive’s goal is to meet those needs by providing a range of products and solutions. The da Vinci X System helps us continue to do so.”

www.intuitivesurgical.com

Tissue ablation system

AngioDynamics received FDA 510(k) clearance for the Solero Microwave Tissue Ablation (MTA) System, which features the Solero Microwave (MW) Generator and the Solero MW Applicators. The solid state Solero MW Generator, with a 2.45GHz operating frequency, can power up to 140W for fast ablations.

The Solero MW Applicator’s ceramic tip diffuses energy nearly spherically, and its patented cooling channel with thermocouple provides real-time monitoring to help protect non-targeted tissue ablation. The Solero MTA System also offers physicians scalability with a single applicator designed for multiple, predictable ablation volumes by varying time and wattage.

www.angiodynamics.com