Approvals

Shockwave Medical Gains CE Mark for Coronary Lithoplasty System

Shockwave Medical has achieved a CE mark for the Coronary Lithoplasty system for the treatment of calcified plaque in conjunction with stenting in patients with coronary artery disease. The device integrates a balloon catheter and sonic pressure waves to break down calcium.

The system is an investigational device in the U.S.

Exactech Wins FDA Clearance for Computer-Assisted Shoulder Arthroplasty

Florida–based Exactech has received clearance from the FDA to market the ExactechGPS shoulder application.

The preoperative planning tool is designed to help surgeons understand their patient’s anatomy prior to surgery. ExactechGPS provides visibility into the glenoid vault in real time and allows for accurate placement.

The company plans to launch the device in the U.S. this summer is planned for this quarter.

Oxitone Medical Wins FDA Clearance for Wrist-Sensor Pulse Oximetry Bracelet

Oxitone Medical has received marketing clearance from the FDA for its wrist-sensor pulse oximetry bracelet Oxitone 1000. The device measures vital signs such as SpO2 and pulse rate with the same precision as fingertip pulse oximeters.

The bracelet uses springs and dampers to isolate the unit from wrist movement and topographical variations.

Body Vision Medical Receives FDA Clearance for the LungVision Navigation System

Israel–based Body Vision Medical has received FDA clearance to market LungVision, an imaging system that enables accurate navigation during bronchoscopic procedures.

The device combines fluoroscopy with high resolution imaging and computed tomography.

Ophtec Wins CE Mark for Precizon Presbyopic

Ophtec has received a CE mark for its Precizon Presbyopic intraocular lens.

The lens uses continuous transitional zones to treat presbyopia, a condition associated with aging that reduces the ability to focus clearly on close objects.

EMED Technologies Wins Expanded Indication for Syringe Infusion System

EMED Technologies has been granted expanded indications on its FDA-cleared SCIg60 infusion system. The device administers human plasma-derived immunoglobulin biologics.

The FDA has created a new device code “PKP” to classify and regulate infusion systems for immunoglobulins.

Avacen Medical Wins CE and Health Canada Approval For Pain Treatment Device

Avacen Medical has received a CE mark and Health Canada approval for its Avacen 100.

The device infuses heat into the circulatory system to provide muscular relaxation and increases circulation to provide pain relief.