Approvals

MaxQ AI’s Intracranial Hemorrhage Platform Cleared by FDA

The FDA granted 510(k) clearance to MaxQ AI’s Accipio Ix intracranial hemorrhage platform.

The device is designed to detect intracranial hemorrhage (ICH), commonly known as brain bleed, in adult non-contrast head computed tomography.

Accipio Ix, which received the CE Mark earlier in the year, uses AI algorithms to identify and mark potential regions of interest related to acute ICH.

FDA Grants 510(k) Clearance for Siemens’ Mobile C-Arm

The FDA has cleared Siemens Healthineers’ Cios Spin, a mobile C-arm that produces 3D images for improved quality assurance during surgical procedures.

The device is used to provide 3D imaging similar to computed tomography (CT) for orthopedic, spinal and traumatic surgery.

The 3D images the Cios Spin produces can remove the need for CT after the procedure and can help reduce the number of needed revisions.

Teleflex Gains Japanese Approval for Urolift System

NeoTract, a Teleflex subsidiary, received approval from Japan’s Ministry of Health, Labor and Welfare for its Urolift system intended for benign prostatic hyperplasia treatment.

In the common and treatable urinary condition, also known as prostate gland enlargement, the prostate enlarges and surrounds part of the urethra.

Teleflex’s system uses a minimally invasive procedure that places tiny devices in the urethra to reopen the lower urinary tract by moving tissue blockage away from the enlarged prostate.

Lumendi Cleared for Endolumenal Interventional Platform

The FDA granted 510(k) clearance for Lumendi’s endolumenal interventional platform used to improve tissue retraction during therapeutic endoscopies.

The device’s suture loops help to facilitate tissue manipulation and simplify dissection and removal of stomach polyps without surgical intervention.

The single-use, close-fitting non-sterile sleeve covers a standard endoscope to stabilize it inside the large intestine and can shift many gastrointestinal surgeries to endolumenal procedures.

Atlantic Therapeutics’ Transcutaneous Electrical Stimulator Cleared

The FDA issued de novo clearance to Atlantic Therapeutics’ INNOVO therapy device, used to treat stress urinary incontinence.

The company’s transcutaneous electrical stimulator is the first device of its kind to be granted FDA approval.

INNOVO is a non-invasive, novel wearable device for women with stress urinary incontinence and is designed to be used at home.

Mesa Biotech Obtains CE Mark for Respiratory Syncytial Virus Test

The EU granted Mesa Biotech’s respiratory syncytial virus (RSV) point-of-care test the CE Mark.

The test, which diagnoses the highly contagious RNA virus, is designed for use with the devicemaker’s polymerase chain reaction testing platform.

The RNA virus affects nearly all children by the time they are two years old and is severe in children with underlying diseases.

BioFire Diagnostics’ Pneumonia Panels Cleared by FDA

The FDA granted 510(k) clearance for BioMérieux affiliate BioFire Diagnostics’ panel assay for detecting lower respiratory tract infections.

The PCR-based panels are able to distinguish between 33 common pathogens that cause pneumonia. A version of the panel featuring an extra target has also received the CE Mark.

The panels, which give test results in approximately one hour, have been cleared for use with sputum and bronchoalveolar lavage samples.

Medtronic Receives CE Mark for Thoracic Stent Graft

Medtronic received a CE Mark for its Valiant Navion thoracic stent graft, used to repair lesions in the descending aorta.

The stent graft is intended for use in minimally invasive therapies to treat a variety of aortic conditions, including thoracic aortic aneurysms, blunt traumatic aortic injuries, intramural hematomas and type B aortic dissections.

The device is a low-profile version of the company’s Captivia thoracic stent system and allows patients with small iliac arteries to undergo thoracic endovascular aneurysm repairs.

Diabeloop Receives CE Mark for Blood Sugar Monitoring Technology

Diabeloop’s DBLG1 technology for monitoring and maintaining blood sugar levels has earned the CE Mark.

The self-learning, customizable system can mimic the pancreas’ insulin-dispensing functions and adapt to the patient.

The DBLG1 links to a continuous blood glucose monitoring system and an insulin patch pump to predict glucose levels and optimally control the pump.