Approvals

FDA Approves Monthly Buprenorphine MAT for Opioid Use Disorder

The FDA approved Invidior’s Sublocade, the first once-monthly buprenorphine injectable as a medication-assisted treatment for opioid use disorder.

Buprenorphine, a partial opioid agonist, is one of three drugs approved as an opioid MAT. First approved in 1981, it is currently available as a generic tablet, dissolvable film or implant.

Last month, two FDA advisory committees overwhelmingly recommended approval of the pre-filled syringe; it will be distributed only to healthcare professionals for injection, to reduce the chances of diversion.

FDA Clears Flushable Lia Diagnostic Pregnancy Test

Lia Diagnostics achieved 510(k) clearance for a flushable, biodegradable pregnancy test for over the counter use.

The Lia Diagnostic Pregnancy Test features proprietary coating technology. The device is made from the natural, plant fibers used in most toilet papers and weighs less than six squares of the lading three-ply toilet paper.

FDA Approves EluNIR Drug-Eluting Stent System

Cardinal Health’s interventional cardiovascular business, Cordis, and Medinol have scored FDA approval for their EluNIR drug-eluting stent system.

The EluNIR DES, which previously obtained CE Marking, is indicated for treating narrowing or blockages in patients with coronary artery disease — a common type of cardiovascular disease.

The stent was designed to have the “narrowest strut width of any stent in the U.S. market” to make it easy to use for clinicians, the companies said.

FDA Clears Camber Spine 3D-Printed Interbody Fusion Implant

The FDA issued 510(k) clearance to Camber Spine for its SPIRA –C Open Matrix Cervical Interbody device.

The 3D-printed implant features a roughed titanium surface designed to promote bone cell proliferation, and a pore size optimized for bone ingrowth.

It is indicated for use at one or two contiguous intervertebral levels in patients who have received at least six week of nonsurgical treatment for degenerative disk diseases. This is the second clearance the firm has obtained over the last four months for an implant in its SPIRA family.

VitalConnect Extends Wear Duration of Wearable Biosensor

VitalConnect has secured its fifth 510(k) clearance for a 25 percent extension in the wear duration of its wearable sensor — the VitalPatch — from 96 hours to 120, or five days.

The disposable biosensor is indicated for single patient use. It is the “smallest and lightest wearable biosensor” for the continuous, real-time monitoring of eight biometric measurements, including single-lead electrocardiography, heart rate, and activity, the company said.

Varian Secures ANVISA Registration for Halcyon Treatment System

California devicemaker Varian Medical Systems received registration from Brazil’s ANVISA for its Halcyon treatment system.

The system is designed to enhance image-guided radiotherapy treatment for cancer. Halcyon can provide volumetric imaging in 15 seconds and the treatment workflow can be completed with nine steps.

Varian obtained Shonin Approval to introduce the device for commercial distribution in Japan last month.

Hologic’s 3rd Respiratory Assay Snags FDA Clearance

The FDA cleared the third Hologic respiratory assay for use in its Panther Fusion system.

The AdV/hMPV/RV assay is indicated for the detection of adenovirus, human metapneumovirus, and rhinovirus. The other two respiratory assays that run in the Panther Fusion system — the Flu A/B/RSV assay and the Paraflu assay — received FDA clearance in October. The assays can perform multiple tests using a single sample.

FDA Approves Boston Scientific’s Deep Brain Stimulation System

Boston Scientific won FDA approval for its Vercise deep brain stimulation system.

The system is indicated for treating symptoms of Parkinson’s disease by delivering adaptable stimulation of a region in a patient’s brain through implanted leads, powered by an implantable pulse generator device.

The battery-powered device was developed using cochlear implant technology. The battery is rechargeable and the battery can last up to 15 years or more.

Intersect ENT Snags FDA Approval for In-Office Sinus Implant Treatment

The FDA approved the SINUVA Sinus Implant, manufactured by Intersect ENT.

SINUVA is designed using bioabsorbale polymers to treat recurrent nasal polyps in patients who have previously undergone sinus surgery.

It can be inserted by physicians trained in otolaryngology during a routine office visit. It works by expanding the sinus cavity to deliver an anti-inflammatory steroid to the polyp disease site.

The implant softens and polyps decrease over time so patients have the ability to remove it by simply sneezing or blowing their nose after 90 days or earlier.