Approvals

FDA Clears Sealing Instrument for Intuitive’s Surgical Systems

The FDA granted Intuitive clearance for its SynchroSeal vessel sealing instrument and accompanying E-100 generator for its da Vinci surgical systems.

The new devices help surgeons seal and transect tissues and vessels more quickly, improving procedures performed by the company’s da Vinci X and Xi robotically-assisted surgical systems that require sealing.

The SynchroSeal instrument uses advanced bipolar energy to transect tissue and cool down quickly in a one-step process performed with a single pedal press.

EOS Imaging Gets 510(k) Clearance for X-ray System

EOS Imaging received 510(k) clearance from the FDA for its EOSedge X-ray system, a device used for high-quality musculoskeletal imaging exams.

The system is the first of its kind to use a high-resolution photon counting detector to provide high image quality. It features an open cabin with an enlarged patient platform for comfortable access and larger fields of examination.

The device uses FlexDose technology, which controls the radiation dose delivered to the patient.

NeuroOne’s Cortical Electrode Cleared by FDA

The FDA issued 510(k) clearance for NeuroOne’s Evo thin film cortical electrode, a device used to temporarily stimulate, monitor and record brain activity.

This thin film technology “offers the potential for improved resolution during recording brain activity, future placement through a less invasive procedure, and reduced inflammation of brain tissue,” the company said.

NeuroOne plans to apply its cortical electrode technology to other devices for use with therapeutic applications for Parkinson’s disease, epilepsy and for spinal cord stimulation.

CryoLife Nabs CE Mark for Minimally Invasive Thoracic Stent Graft

CryoLife earned the CE Mark for its E-nya thoracic stent graft system for minimally invasive repairs of descending thoracic aorta lesions, including thoracic aortic aneurysms and dissections.

The device features different configurations, including bare spring and covered proximal configurations, to give physicians more flexibility and control for simple and complex anatomies.

Most patients with thoracic aortic disease are treated using minimally invasive endovascular stent grafts.

FDA Approves Tusker Medical’s Ear Tube Delivery Device

The FDA granted Tusker Medical approval for its Tubes Under Local Anesthesia (Tula) system, a tympanostomy tube delivery device for treating recurrent ear infections, also known as otitis media.

The device is the first ear tube delivery system that can be used in young children using local anesthesia in the doctor’s office, enabling treatment without the use of general anesthesia, the agency said.

The system uses Tusker Medical’s ear tubes, its anesthetic Tymbion, and several devices used to deliver the ear tubes and anesthetic into the ear drum.

Venus Concept Nabs CE Mark, Canadian OK for Laser Hair Removal System

Venus Concept has received both the CE Mark and a Health Canada medical device license for its Venus Epileve product, a portable laser hair removal device.

The device is intended as a treatment for male-pattern hair growth in women, permanent hair reduction and razor bumps in Europe, and for hair removal and permanent hair reduction in Canada.

The product features a real-time cooling system for patient safety and comfort. A limited launch is planned in the second quarter of 2020, followed by a full launch in the second half of the year.

Renovia Earns 510(k) Clearance for Urinary Incontinence Treatment

Renovia has received 510(k) clearance from the FDA for its Ieva Pelvic Digital Therapeutic, a device used to strengthen the pelvic floor muscles and treat mild to moderate urinary incontinence in women.

The device offers real-time feedback to women performing pelvic floor muscle exercises by using a movement-based sensor.

The company plans to publish the results of its recently completed multi-center trial “in the coming months,” noting that the study found statistically better results for users of the UI treatment. A larger multi-center trial is planned to kick off in the first half of 2020, Renovia said.

FDA Clears Disposable Sheath for Hysteroscopy System

UVision360 has received 510(k) clearance for a rotatable disposable sheath attachment for its Luminelle DTx hysteroscopy system.

The system uses a wide-angle lens, long depth of view and an algorithm that automatically adjusts focus and lighting during hysteroscopy and cystoscopy procedures.

The newly cleared attachment measures 3mm in diameter, reducing the need for anesthesia due to its small size, the company said.