Approvals

Quidel’s Bordetella Assay Receives FDA Clearance

The FDA granted 510(k) clearance to Quidel’s Solana Bordetella assay, a molecular diagnostic assay used with its Solana molecular diagnostic instrument for detection of pertussis bacteria.

Together, the assay and diagnostic instrument can differentiate between Bordetella pertussis and Bordetella parapertussis nucleic acids obtained from patients suspected of having a respiratory tract infection caused by the bacteria.

Pertussis, also known as whooping cough, is highly contagious and it has become more common in recent years.

FDA Grants Expanded Clearance for Nova Biomedical’s Glucose Meter

Nova Biomedical received 510(k) clearance for its StatStrip glucose hospital meter system, the first finger-stick capillary testing meter for critically ill patients with and without diabetes.

The device can now be used with capillary, venous and arterial specimens from all patients. It can be used for point-of-care testing to measure and correct for abnormal hematocrit, the percentage of blood by volume that is made up of red blood cells.

The new clearance eliminates the need for hospitals using StatStrip to define “critically ill” patients for testing purposes.

Zavation Receives FDA Clearance For Expandable Corpectomy Cage

The FDA granted 510(k) clearance to Zavation’s Normandy vertebral body replacement system.

The device is placed in the vertebral body space to provide structural stability in skeletally mature patients. It is made up of spacers that come in various sizes and types to accommodate the patient’s anatomy.

The device is indicated for use in the cervical and thoracolumbar spine for replacement of vertebral body due to tumor, trauma or osteomyelitis, or for reconstruction following the removal of vertebral body and discs.

Vallum Gets 510(k) Clearance for Spinal Interbody Fusion Device

Vallum received 510(k) clearance for its polyetheretherketone PEEKplus nanotextured spinal interbody fusion device, which uses nanotexturing to improve bone fusion and growth.

The surface promotes osteoblast functions needed to grow bone and encourages fusion by generating osteogenic responses.

The nanotexturing can be applied to any PEEK device without impacting its design or size.

Nanotexturing has the potential to set “a new standard in the performance of spinal fusion interbody implants,” according to Eric J. Woodard, chairman of Vallum’s medical advisory board.

Adaptiiv Cleared to Market 3D Bolus Software

The FDA granted 510(k) clearance for Adaptiiv’s 3D bolus software, allowing the company to market the 3D printing software in the U.S.

The software is used to create 3D customized personal medical devices, primarily for the treatment of cancer.

The patient-specific devices can be used during radiation treatment to address issues practitioners face, such as air gaps in bolus and sparing healthy tissues during electron treatments.

Lumendi Receives CE Mark for Endoscope Accessory

Lumendi gained a CE Mark for its DiLumen endolumenal interventional platform for use as an endoscope accessory in endolumenal weight loss procedures.

The device, a non-sterile, single-use sleeve, is meant to allow complete positioning of a conventional endoscope in the large intestine.

The accessory gives users increased visualization, and its endolumenal approach is expected to avoid incisions and minimize the need for general anesthetics.

Companion Medical’s InPen System Gains Approval

Companion Medical received a CE Mark for its InPen system, an insulin pen that is also cleared by the FDA.

The insulin pen features an accompanying integrated diabetes management app. The app is currently available for iPhones, and a launch for Android is planned for later this year.

The device gives information on aggregated glucose, insulin and meal data. It offers daily views that let providers monitor the patient’s patterns related to glucose adherence and control.

Mirada’s AI Software Cleared by FDA

The FDA granted 510(k) clearance for imaging software developer Mirada’s artificial intelligence DLC Expert software, approving it to be used for planning radiation oncology treatment.

The software helps users spot tumors and important structures on patient CT scans, reducing the time it typically takes to perform an analysis.

The software is part of Mirada’s Workflow Box 2.0 Zero-Click platform, which provides data routing and support for custom applications.

Candela Cleared for Pulsed Dye Laser

Candela received FDA’s 510(k) clearance for its Vbeam Prima device, a pulsed dye laser used to treat a range of skin conditions.

The 595 nm pulsed dye laser device is cleared for treating conditions like rosacea, acne, spider veins, port-wine stains, wrinkles, warts and stretch marks, as well as photo aging and benign pigmented lesions.