FDA Approves Obalon Balloon System
Obalon Therapeutics received approval from the FDA for its Obalon Balloon System, which is a nonsurgical and fully reversible device for weight loss.
The Obalon Balloon System consists of a balloon folded inside a capsule that is swallowed by the patient, with no sedation or anesthesia required.
In clinical trials, roughly 65 percent of patients who received the device experienced clinically meaningful weight loss of at least 5 percent of their total body weight.
The Obalon Balloon System is expected to be available in early 2017.
Japan Approves Medtronic Cardiac Monitor
Japan’s Ministry of Health, Labour and Welfare approved Medtronic’s Reveal LINQ Insertable Cardiac Monitor.
The country’s pricing body also agreed to reimburse the insertable cardiac monitoring system.
Designed to help physicians diagnose irregular heartbeats, the device is one-third the size of a AAA battery and is placed beneath the skin through an incision in the upper left side of the chest.
In Japan, the cardiac monitor will be used to diagnose unexplained fainting and cryptogenic stroke.
Medtronic Drug-Coated Balloon Cleared for ISR
The FDA approved Medtronic’s IN.PACT Admiral drug-coated balloon for treating in-stent restenosis in patients with peripheral artery disease.
The expanded indication for the device marks the first approval in the U.S. for a drug-coated balloon (DCB) to treat ISR. The agency approved the device in 2014 to treat superficial femoral and popliteal arteries.
ISR occurs when a stent is placed in the artery to restore blood flow but over time plaque can form in and around the stent. This condition is estimated to occur in up to 40 percent of all stents placed in the superficial femoral artery, according to Medtronic.
VisuMax Femtosecond Laser Approved
Carl Zeiss Meditec’s VisuMax Femtosecond laser was approved for the small incision lenticule extraction (SMILE) procedure to reduce or eliminate nearsightedness in patients 22 years of age or older.
The VisuMax Femtosecond laser removes a small amount of eye tissue to permanently reshape the cornea. A femtosecond laser makes cuts within the cornea, creating a disc-shaped piece of tissue that is removed through a small incision in the surface of the cornea.
Ossix Volumax Receives FDA 510(k)
Datum Dental’s Ossix Volumax dental regenerative has received FDA 510(k) clearance.
The product is designed to restore lost volume in guided bone regeneration, guided tissue regeneration and soft tissue augmentation cases.
SyntheticMR’s MAGiC Gains 510(k)
SyntheticMR’s partner, GE Healthcare, has received 510(k) clearance for MAGiC, a customized version of SyntheticMR’s SyMRI Image software marketed by GE Healthcare.
MAGiC (Magnetic Resonance Image Compilation) is the industry’s first multi-contrast magnetic resonance (MR) technique to be cleared by the FDA.