Approvals

THINK Surgical Gets CE Mark for Total Knee Arthroplasty System

THINK Surgical snagged a CE mark for its TSolution One surgical system.

The system provides active robotic precision for total knee arthroplasty procedures.

The robot removes diseased bone and prepares the bone cavity and the joint surface so surgeons can accurately fit and align the joint implant.

CompactCath Receives CE Mark for Its Intermittent Urinary Catheter

CompactCath received a CE Mark for its intermittent urinary catheter as a Class III medical device.

The device features a drainage control mechanism and non-touch insertion.

Omnia Medical VBR Receives FDA 510(k) Clearance

Omnia Medical VBR received FDA 510(k) clearance for a vertebral body replacement system.

The device was manufactured from an osteoconductive polymer for use in the thoracolumbar spine to replace a collapsed, damaged, or unstable vertebral body.

The enhanced biomaterial offers clinical advantages such as stiffness similar to cortical bone, reduced stress shielding and artifact-free imaging that allows for clear assessments of fusion.

FDA Clears XableCath Blunt Tip Catheter

The FDA cleared XableCath’s blunt tip support catheter indicated for treating peripheral arterial disease.

The catheter is designed to facilitate over-the-wire the passage of true lumen through lesions above and below the knee in the peripheral vasculature.

The company said it expects the device to be used in the first U.S. surgical procedures during the first half of 2018.

German Devicemaker Gets CE-IVD Mark for Lung Cancer Assay

Epigenomics, a Germany-based molecular diagnostics company, received the CE-IVD mark for its blood-based lung cancer test Epi proLung.

The device includes the company’s proprietary DNA methylation biomarkers.

The European Commission provided funding for the assay’s development.

K2M Group Receives CE Mark for 3D-Printed Expandable Cage System

K2M Group earned a CE Mark for its 3D-printed expandable cage system, the first 3D-printed expandable device on the market to facilitate continuous in-situ height expansion and endplate angulation in the cervical spine.

The system, which features the company’s Lamellar 3D titanium technology, is designed to stabilize the cervical spine in patients needing treatment for trauma or tumors.

French Device Firm Snags CE Mark for Smart Sensor

France-based BIOCORP received a CE mark for its Epi proLung for use with insulin delivery injectors.

The device includes a smart cap sensor designed to turn all traditional pen injectors into connected devices. It captures treatment information, including dosages, date and time, which is then transferred to a patient monitoring mobile app.

FDA Grants Early Marketing Approval to Biom’Up Flagship Device

French device manufacturer Biom’Up announced it secured FDA marketing approval for its Hemoblast Bellows device seven months ahead of schedule.

The device is used to control bleeding during surgery. The FDA based the approval on a 412-patient clinical trial that met all clinical endpoints with high statistical significance.

The company plans to market the device in the United States by next summer.

TGA Signs Off on Glucose Monitor for iPhones

Australia’s Therapeutic Goods Administration issued a TGA Mark for DarioHealth’s blood glucose monitoring system for iPhone use.

The system was previously unapproved for the Lightning connector found in later-model Apple smartphones. The approval ensures users in the United Kingdom will have access to the Lightning-enabled Dario device at the end of December. Sales of the device in Australia will begin in January, the company said.

FDA Clears Laser Endomicroscopy Platform

Mauna Kea received 510(k) clearance from the FDA for its Cellvizio multidisciplinary confocal laser endomicroscopy platform.

The agency based the clearance on data from peer-reviewed medical journals that validated the device’s capacity to image tissue microstructures.

Clearing this hurdle will allow the company to shift its focus from imaging to identification, according to the firm’s founder and CEO Sacha Loiseau.

Senzime’s OnZurf Probe Scores CE Mark

Senzime’s OnZurf Probe device received CE Mark approval within Europe, with an initial direct sales period in Scandinavia planned.

The device is intended for use after gastrointestinal tract procedures. It continuously collects organ surface samples. It can monitor postsurgical healing and flag warning signs of post-operative complications. The company anticipates CE approval for its corresponding analyzer by the second half of 2018.