Approvals

Eximo Medical’s Atherectomy Laser Cleared by FDA

The FDA granted 510(k) clearance for Eximo Medical’s B-Laser atherectomy system, used for treating patients with peripheral artery disease, including in-stent restenosis.

The device — the first 355nm laser system cleared in the U.S. — is used in atherectomy procedures, minimally invasive procedures that remove atherosclerosis from a patient’s blood vessels.

Atherectomies offer an alternative to angioplasties, which involve inflating temporary balloons to widen and unclog arteries.

FDA Approves Zeiss Treatment for Astigmatisms

Zeiss’ ReLex Smile received premarket approval from the FDA, expanding its myopia treatment options to include patients with astigmatism.

The approval allows for a small incision lenticule extraction (Smile) procedure that is less abrasive on corneal surface tissue.

The procedure uses Zeiss’ VisuMax femtosecond laser to create a lenticule and incision inside the cornea in a single step.

Bioneer Gains CE Mark for HIV-1 Kit

Bioneer earned CE-IVD marking for its HIV-1 quantitative analysis kit that uses a reverse transcription polymerase chain reaction technique to detect RNA expression.

The kit runs on the South Korea molecular diagnostics firm’s ExiStation automated molecular diagnostics system.

The kit is used to count the presence of HIV-1 RNA in patient blood samples.

Mighty Oak Medical’s Midline Navigation Guide Cleared

The FDA granted Mighty Oak Medical 510(k) clearance for its Firefly midline navigation guide, a 3D-printed and patient-specific device designed for cortical bone trajectory for pedicle screws.

The Firefly, which is used for bone fixation, is compatible with every pedicle screw system.

The guide mechanically follows a predetermined trajectory and can eliminate the need for an O-arm imaging system or robot.

FDA Clears RightEye’s Vision System

RightEye’s vision system — also called RightEye — received 510(k) clearance from the FDA for recording, analyzing and viewing patient eye movements.

The portable system is used to support the identification of visual tracking impairments and perform vision-derived health screening.

The system comes with multiple applications, including functional vision screening, reading proficiency assessments and sports-related vision assessment and training.

FDA Clears Bose’s Hearing Aid for Marketing

The FDA granted marketing authorization to the Bose Hearing Aid for patients 18 and older with mild to moderate hearing loss.

Patients can adjust the hearing aid using a mobile application on their phone. The wireless device is the first hearing aid that can be programmed and controlled by patients without any interaction with a health care provider.

The FDA cleared the device under the De Novo premarket review pathway based on data from clinical studies of 125 patients that showed self-fitting by patients was comparable to fittings by professionals.

SpineEX Interbody Fusion Device Gets 510(k) Clearance

The FDA cleared SpineEX’s Sagittae lateral lumbar interbody fusion (LLIF) device for use in spinal fusion surgeries.

The minimally invasive fusion procedure causes less disruption to lower back muscles because it approaches from the patient’s side, resulting in faster recovery and less blood loss.

The personalized device is expandable and offers a large graft space ideal for lumbar fusion procedures.

FibriCheck’s Heart Monitor App Cleared by FDA

The FDA granted 510(k) clearance for FibriCheck’s heart monitor smartphone application, which is used to detect issues with the user’s heart rhythms.

FibriCheck’s app — which is expected to be launched on the U.S. market in 2019 — uses the phone’s camera and software to monitor patients for heart rhythm disorders.

FDA Clears DDC Technique For K2M’s Mesa Platform

K2M’s dual differential correction (DDC) technique was granted 510(k) clearance by the FDA for use with the company’s Mesa Platform.

The platform is used for treating patients with, front-to-back imbalances in the spine that occur when one of the natural curves of the spine becomes under- or overly-pronounced.

The DDC technique uses patient-specific rods and rails, as well as rod rigidity and degree of bend, to correct spinal imbalances in the patient.