Approvals

FDA Clears Viseon’s Voyant System

Viseon’s Voyant system received 510(k) clearance for use in minimally invasive spinal surgery access, visualization and illumination.

The device includes HD imaging sensor and illumination technology, and consists of a single-use sterile disposable retractor and a reusable controller for moving the site image.

The system allows surgeons to change the depth of focus and view the surgical site on HD flat-panel display monitors in the operating room.

Co-Diagnostics Gains CE Mark for Zika Screening Test

Co-Diagnostics received the CE Mark for its Logix Smart Zika screening test.

The polymerase chain reaction test can detect Zika’s presence in plasma collected from patients suspected to be infected.

Studies have linked Zika with cases of microcephaly, a neurological disease that affects the brain development of fetuses.

Dexcom Wins CMS Coverage for Continuous Glucose Monitor

Dexcom announced that the Centers for Medicare & Medicaid Services agreed to cover its G6 continuous glucose monitoring system for Medicare beneficiaries.

The system features a redesigned applicator that inserts a small sensor below the user’s skin to continuously measures glucose levels for up to 10 days and transmit the data to a display device.

The G6 won FDA approval in March and a CE Mark in April. The company expects to start shipping the system to Medicare customers in early 2019.

Matrix Surgical’s OmniPore Implants Cleared for Marketing

Matrix Surgical USA received 510(k) clearance from the FDA to market its OmniPore DUROMAX surgical implants for non-weight-bearing applications of maxillofacial and orbital reconstruction, cosmetic surgery and repair of maxillofacial and orbital trauma.

The orbital implant builds upon the company’s previously cleared high-density polyethylene craniofacial implant platform by adding titanium inside the porous polyethylene framework. The titanium retains shape after manipulating by hand and is radiopaque on post-operative computer tomography (CT) scans, unlike regular porous polyethylene implants.

Additional variants are currently in development and are expected to be launched in early 2019 in markets where the company has regulatory clearances.

FDA Clears OrthoPediatrics’ Scoliosis System

The FDA granted 510(k) clearance to OrthoPediatrics’ Response 4.5/5.0mm system for treating complex scoliosis in younger patients of smaller stature.

The clearance expands the pediatric orthopedic devicemaker’s Response platform, enabling it to treat smaller patients. It allows the surgeon to choose between a 4.5mm CoCr rod or a 5.0mm titanium or cobalt chromium/chrome rod.

OrthoPediatrics expects to launch the system in the fourth quarter of 2018.

OssDsign’s Regenerative Cranial Implant Cleared by FDA

The FDA cleared OssDsign’s Cranioplug, a cranial implant used during neurosurgical procedures to cover and plug holes made in the skull during surgery.

The Cranioplug, which is composed of an osteoconductive calcium phosphate ceramic and reinforced with titanium mesh, is meant to help reattach cranial bone taken out during surgery.

Its ceramic component resorbs and is eventually replaced by bone as the healing process takes its course. It can be used in patients aged 12 and older.

FDA Expands Indication of Levita’s Magnetic Surgical System

Levita Magnetics received FDA clearance for an expanded indication of its magnetic surgical system for use in bariatric procedures.

The shaftless device — an external magnet placed on the skin that controls a detachable grasper — was originally indicated for gallbladder removal procedures, and can now reduce the amount of incisions and trocars needed in bariatric procedures.

The implant enables surgeons to move instruments without being restricted by a fixed-position pivot point and improves their visualization of the surgical site.

Gogoa Mobility Robots Earns CE Mark for Exoskeleton

Gogoa Mobility Robots earned a CE Mark for HANK, its lower limb exoskeleton system for use in rehabilitation of adults such as stroke patients following neurological injury. The system can also be used for gait compensation in patients who have paralysis of the lower limbs following spinal cord injuries.

HANK is the first exoskeleton for clinical use with a CE Mark and the first medical exoskeleton of its class with motorized ankles, allowing for more natural range of motion, the company said.

“Europe is the new hotbed for start-ups in the robotic rehabilitation field and we are proud to be the first EU company to get the certification,” said Gogoa’s CEO Carlos Fernandez.