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Approvals

August 2, 2019

FDA Clears New Indications for Lyme Disease Diagnostics

The FDA has OK’d four diagnostic tests with new indications for diagnosing Lyme disease.

“The tests cleared today are the first time that a test has been indicated to follow a new testing paradigm in which two tests called enzyme immunoassays (EIA) are run concurrently or sequentially” rather than the current two-step Western Blot test, the agency said.

The new assays are easier to interpret in the laboratory due to the streamlined methods for running the tests, CDRH said.

Elekta’s Radiation Therapy System ‘Unity’ Gains Canadian Clearance

Canada’s Canadian Nuclear Safety Commission has given the go-ahead for the clinical use of Elekta’s Unity magnetic resonance radiation therapy (MR/RT) system.

The system uses an MRI scanner and a linear accelerator backed by adaptive software to adjust doses of radiation therapy based on daily changes in the tumor’s shape, size and position and the surrounding healthy tissue.

Elekta CEO Richard Hausmann says the system is “changing how leading cancer centers deliver radiation therapy, reshaping the dose in real time and targeting hard-to-treat cancers that previously could not be treated effectively with radiation.”

FDA Approves Intersect ENT’s Sinus Implant Delivery System

Menlo Park, California devicemaker Intersect ENT said that the FDA has approved the delivery system for its Propel Mini sinus implant.

The company’s new Straight Delivery System is designed to place the Propel Mini steroid releasing sinus implant in the ethmoid sinus. The implant helps keep the sinus open during delivery of mometasone furoate, a steroid medication used to treat skin conditions.

The sinus implant helps to improve the outcomes of frontal and ethmoid sinus surgery.

Life Spine’s Expandable Spacer System Earns Additional FDA Clearance

The FDA has handed Life Spine 510(k) clearance for two new widths of its Prolift expandable spacer system

The agency cleared the device in 8mm–10mm widths, enabling the device to accommodate a wider range of patients that require transforaminal lumbar interbody fusion (TLIF) and posterior lumbar interbody fusion (PLIF) procedures.

“As opposed to traditional static interbodies, Prolift was engineered to reduce the need for surgical steps, such as sequential trialing, and in turn reduce operating time,” Life Spine said.

OrthoPediatrics’ Cannulated Screw System Cleared by FDA

The FDA has granted OrthoPediatrics 510(k) clearance for its Cannulated Screw System, a device used to treat bone fractures and fusions in smaller patients.

The new screws are made of stainless steel and come in 2.5mm, 3mm, 3.5mm, 4mm, 4.5mm and 5.5mm sizes. It also offers an “all-in-one” option that increases operating room efficiency.

The company’s executive vice president, David Bailey, said the device is “innovative as it allows physicians to adequately address the issue when first detected/present.”

Ortho Clinical Gains CE Mark for Cardiac Assay

Ortho Clinical Diagnostics has received the CE Mark for an improved version of its Vitros NT-proBNP II product, a diagnostic used to identify heart failure.

The assay is also designed for risk stratification — grouping patients based on their risk and rising risk — of acute coronary syndrome and heart failure.

The enhanced version of the assay has improved assay quality through the use of monoclonal antibodies and an enhanced resistance to potential interferences.

FDA Clears MiRus’ Spine Alignment Monitoring System

MiRus’ Galileo Spine Alignment Monitoring System has received 510(k) clearance from the FDA for spinal alignment.

The wireless, non-optical device is a real-time measurement system used in segmental and global sagittal spine alignment. It provides surgeons with feedback as they perform corrective procedures in the operating room and confirms that the alignment was successful.

According to the company, the device is the first product approved by the FDA that measures sagittal plane alignment in real-time without the heavy use of repeated imaging.

FDA Clears Wound Dressing for Treating Mustard Gas Injuries

Argentum Medical has received 510(k) clearance for its Silverlon Wound Contact Dressing for the treatment of certain injuries caused by sulfur mustard, most commonly known as mustard gas.

The agency’s decision marks its first approval of a product to manage certain blister injuries caused by mustard gas.