Approvals

FDA Clearance Combines Invisalign With Mandibular Advancement

The FDA has given 510(k) clearance to Align Technology’s Invisalign treatment with mandibular advancement, allowing the two technologies to be used together.

The agency’s clearance allows the clear-aligner treatment to be used with mandibular advancement to simultaneously reposition the jaw and align the teeth of teenage patients aged 12 to 13.

Invisalign treatment combined with mandibular advancement can replace Class II elastics and appliances and reduce costs and time for adjustments and repairs.

Zimmer Biomet’s Revision Knee System Cleared by FDA

The FDA granted 510(k) clearance for Zimmer Biomet’s Persona revision knee system for use in revision knee replacement procedures.

The knee system enables surgeons to perform simple and complex revision procedures using their preferred approach.

It is matched according to a patient’s anatomy to achieve a personal fit.

PlexBio’s Lung Cancer Panel Gains CE Mark

Taiwanese diagnostics manufacturer PlexBio has received the CE Mark for its IntelliPlex lung cancer panel, used for identifying DNA mutations.

The assay can recognize 36 DNA mutations, including ones in the KRAS, NRAS, PIK3CA, BRAF and EGFR genes, and 19 gene rearrangements of ALK, ROS1, RET, NTRK1 and MET genes.

It can use Plexbio’s πCode technology, a circular disk that can create more than 16,000 image patterns for use in multiplexing.

FDA Clears ELITechGroup’s Herpes Assays

ELITechGroup’s real-time PCR assays for detecting herpes simplex viruses 1 and 2 was granted 510(k) clearance by the FDA.

The assays, used with the company’s InGenius sample-to-result device, can detect and differentiate between herpes simplex viruses 1 and 2.

The assays analyze nucleic acid obtained from the patient’s lesions on the skin, genitals, lips or mouth.

Focal Healthcare Gets FDA’s OK for Prostate Fusion Biopsy Device

The FDA cleared Focal Healthcare’s Fusion Bx 2.0, the second generation of the prostate fusion biopsy device.

The device, which uses an MRI to mark potential lesions and ties it to live ultrasound images, makes a 3D model of the patient’s prostate.

The prostate model is used by urologists to target specific regions for biopsy, enabling more accurate and effective prostate cancer diagnoses.

Blue Spark’s Temperature Monitor Receives CE Mark

Blue Spark may now market its TempTraq wearable temperature monitor in Europe after gaining the CE Mark.

The Bluetooth-enabled monitor is a disposable patch that provides caregivers with wireless, continuous temperature data.

TempTraq can send alerts to mobile devices when temperature reaches either pre-determined or user-set levels.

Shoulder Innovations’ Humeral System Cleared by FDA

The FDA granted 510(k) clearance to Shoulder Innovations’ InSet humeral short stem system for use in shoulder arthroplasty.

The system includes products used in partial or total shoulder arthroplasty, a surgical procedure that uses a prosthetic implant to treat degenerative, rheumatoid or traumatic arthritis in the shoulder.

InSet includes coating technology for implant fixation while preserving the humerus bone.

EU Approves Micro Medical’s Microstent

Micro Medical Solutions received CE Mark approval for its 4Fr.-compatible Microstent 120 cm delivery catheter, as well as approval for Microstent devices in five lengths and diameters.

The devicemaker’s newly approved Microstents — which are intended to reduce amputations below-the-knee caused by peripheral artery disease and resulting critical limb ischemia — offer physicians a longer access system and a greater selection of stent sizes.

The technology’s new approvals apply to the 8mm, 15mm, 25mm, 40mm and 60mm sizes, allowing for customized use by the physician.

FDA Clears NinePoint Medical’s Imaging System Upgrade

The FDA cleared an upgrade to NinePoint Medical’s Nvision volumetric laser endomicroscopy (VLE) imaging system.

The Intelligent Real-time Image Segmentation (IRIS) software upgrade is an AI-based platform used for image feature segmentation — dividing a digital image into multiple segments for improved analysis.

The Nvision VLE imaging system is used to allow for VLE procedures that generate real-time, high-resolution, cross-sectioned images. These images are used to evaluate esophageal tissue surface and sub-surface for potential diseases that can’t be seen through traditional technology.