Approvals

Erchonia Laser Gains 510(k) Clearance for Temporary Pain Relief

The FDA cleared Erchonia’s Erchonia Violet and Red Laser (EVRL) device for the temporary relief of chronic neck and shoulder musculoskeletal pain.

The handheld, smart phone-sized low-level laser is the first violet laser (405nm) to receive FDA market clearance for the use on an indication related to pain, the company said.

The product uses low-level laser therapy to avoid the side effects of traditional treatments and different wavelengths to stimulate different types of healing.

Epica Grabs FDA Clearance for Tomography Imaging System

The FDA granted 510(k) clearance to Epica International’s SeeFactorCT3 imaging platform, a device that combines three different imaging systems.

The robotically-controlled platform includes CT, fluoroscopy and digital radiography imaging systems, a detachable patient table and chair, and a sterile drape used for interventional procedures.

The ultra high-resolution system can be moved to patients in an intensive care unit or emergency room and can be operated by physicians, surgeons, dentists, or other qualified professionals.

Gore Earns CE Mark for Atrial Septal Defect Occluder

Gore earned the CE Mark for its Cardioform atrial septal defect (ASD) occluder, a device that closes abnormal openings in the heart.

The minimally invasive device is designed for transcatheter closure of ostium secundum atrial defects and it can be retrieved and repositioned. The device can close defects ranging from eight to 35 millimeters in diameter.

The occluder was recently granted approval by the FDA for the treatment of ASDs.

FDA Clears Exogenesis’ Hernia Mesh

Exogenesis received 510(k) clearance from the FDA for its hernia mesh, a device indicated for repairing abdominal wall hernias and abdominal wall deficiencies that require reinforcing material.

The device consists of monofilament medical grade polypropylene and has a surface treated with the company’s Accelerated Neutral Atom Beam technology.

The mesh provides long-term tissue support and its large pores encourage tissue ingrowth.

Laser Associated Sciences Blood Flow Monitor Cleared

Laser Associated Sciences’ non-invasive blood flow monitoring system, FlowMet-R, received 510(k) clearance from the FDA for detecting peripheral artery disease and gauging the efficacy of treatments.

The device clips onto a patient’s toe and uses a small laser diode and camera to measure blood flow, providing insight on surgical effectiveness.

“By directly measuring limb perfusion during surgeries, physicians can see for the first time whether peripheral blood flow [is] being improved in real time,” says Laser’s CEO Sean White.

Australia Approves Smartphone Diagnostic for Acute Pediatric Respiratory Disease

Australia’s Therapeutic Goods Administration (TGA) has approved ResApp’s ResAppDx-EU, a smartphone-based app for diagnosing and managing respiratory disease in pediatric patients.

The app previously received the CE Mark, which was supported by data from a pediatric clinical study showing that the app’s cough-based diagnosis algorithms had “excellent agreement with a clinical diagnosis,” the company said.

Luminex Grabs FDA Clearance for MRSA Nasal Swab Assay

The FDA granted Luminex 510(k) clearance for its Aries MRSA assay, an in vitro diagnostic test that uses nasal swabs to directly detect methicillin-resistant Staphylococcus aureus (MRSA).

The diagnostic is run on Luminex’s Aries system, that features six FDA cleared and seven CE marked assays and can also run lab-developed tests.

MRSA is usually spread by direct contact with an infected wound or contaminated hands, often those of healthcare providers, according to the CDC.