Approvals

Carrot Lands FDA Approval for Smoking Cessation Mobile Device

California-based digital health company Carrot won 510(k) clearance for the first over-the-counter carbon monoxide breath sensor for use in smoking cessation programs.

The Carbon Monoxide Breath Sensor System’ mobile breath sensor can be paired with a smartphone via Bluetooth to measure carbon monoxide in exhaled breath. It shows users in real-time how their cigarette smoking behavior is impacting their carbon monoxide levels to help them quit smoking.

The company also launched its own smoking cessation program in a smartphone medical application called Pivot.

CardioFocus Earns CE Mark for HeartLight Excalibur Balloon

Cardio Focus received a CE Mark for its HeartLight Excalibur Balloon for treatment of atrial fibrillation.

The device is based on the company’s FDA-approved HeartLight endoscopic ablation system and includes advanced features to optimize tissue contact during pulmonary vein isolation procedures.

The device provides a treatment option for AF patients whose heart arrhythmias are insufficiently controlled with medication.

Novo Nordisk Wins FDA Nod for Fast-Acting Insulin Device

Novo Nordisk received the FDA’s approval for its Fiasp insulin aspart injection for fast-acting mealtime insulin. The device is designed to improve glycemic control for adults with Type I and Type II diabetes.

The device is a redesigned formulation of the NovoLog product, with added vitamin B3 to boost initial insulin absorption and trigger its appearance in the blood in 2.5 minutes.

The approval was supported by a Phase IIIa clinical trial involving more than 2,000 individuals with Type I and Type II diabetes.

K2M Wins FDA Clearance for Yukon OCT Spinal System

K2M Group Holdings received 510(k) marketing clearance for its Yukon OCT spinal system.

The device assists surgeons in restoring cervical spine balance, and to facilitate fusion in the occipito-cervico-thoracic regions of the spine. The system can accommodate rods in
two diameters.

K2M is a pioneer in the 3D-printing of spinal devices.

Mortise Medical Gains FDA Clearance for LigaMetrics Suture Anchor System

Mortise Medical secured 510(k) marketing clearance for its LigaMetrics suture anchor system.

The device is designed specifically for connecting to and locking suture tape attached either to soft tissue or attached to a conventional suture anchor.

Mortise Medical is a medical device company incubated and operated by Surgical Frontiers.