Approvals

FDA Grants 510(k) Clearance to Accuray Data Management System

Accuray secured 510(k) clearance from the FDA for its iDMS data management system.

The system will be used to integrate data from Accuray’s technology platforms such as the TomoTherapy and CyberKnife systems. It allows users to store and manage patient data across numerous devices.

The approval comes shortly after the company published data showing a higher patient survival rate for its TomoTherapy radiation therapy system compared to Varian Medical’s RapidArc radiotherapy system.

Laminate Gets IDE Approval for Study of VasQ Device

The FDA awarded an Investigational Device Exemption to Laminate Medical Technologies to evaluate its VasQ device’s safety and efficacy.

The VasQ is an implanted blood vessel external support for patients needing arteriovenous fistula. Laminate’s clinical trial will enroll 129 male and female patients from 18 to 80 years old and track their progress over two years.

The device is already CE Marked and used in European and Israeli hospitals.

Medtronic Gets CE Mark, FDA Approval for Aortic Surgical Valve

Medtronic announced CE Mark and FDA approval for its new aortic surgical valve.

The Avalus aortic surgical valve is indicated for treatment of aortic valve disease. The device is the only MRI-safe stented surgical aortic valve on the market, according to the company.

The valve features a design built around limiting central regurgitation, a single, one-cut release, and a more durable frame.

FDA Clears Standard Bariatrics Clamp

Standard Bariatrics has secured FDA clearance for its Standard Clamp surgical clamp device.

The disposable laparoscopic device can be used in performing laparoscopic sleeve gastrectomies. The clamps allow surgeons to plan and hold staple lines during laparoscopic sleeve gastrectomy procedures.

Standard has begun commercial U.S. distribution of the device.

FDA Clears Xavant Tech’s Pain Relief Neuromod

Xavant Technology received FDA clearance for its Stimpod non-invasive pain relief neuromodulation device.

The device treats chronic, post-surgical and post-traumatic acute pain through a hybrid pulsed radio frequency waveform. The system uses nerve-locating technology and nerve mapping to track and assess treatment progress.

The South African company said it will use Bell Medical as its distributor for the device in the United States and Canada.

FDA Clears Teva’s Breath-Actuated Inhaler

Teva Pharmaceuticals announced FDA approval for its QVAR RediHaler, a breath-actuated inhaler for asthma in children 4 years or older.

The device delivers a metered dose through breath-activation, leaving no need for hand-breath coordination. Teva’s QVAR metered-distribution inhaler hit the market in 2014. As part of the launch of the RediHaler, the company will discontinue the older device.

The RediHaler is expected to be commercially available during the first quarter of next year.

GE’s Signa Premier MRI Gets FDA Nod

GE Healthcare won FDA 510(k) clearance for its Sigma Premier MRI system.

The company developed the system as part of four-year collaboration with various research institutions and the National Football League to diagnose mild traumatic brain injury. It is the company’s most powerful system for a wide bore MRI.

The system features a digital transmit and receive capability that allows nearly 150 independent receiver channels to acquire patient data.

FDA Gives Nod to Mauna Kea Miniprobes

Mauna Kea announced the FDA granted 510(k) clearance to its CelioFlex confocal miniprobes, designed for use with its Cellvizio device.

The probes provide visualization during laparascopic, endoscopic and robotic-assisted procedures. The approval will enhance providers’ ability to generate imaging for robotic-assisted procedures, according to company founder and CEO Sacha Loiseau.

Cellvizio applications have received clearance in more than 40 countries, including the U.S., Europe, Japan, China, Canada, Brazil and Mexico. Last month, the company released trial data supporting the use of the device in diagnosing pancreatic cysts.

FDA Clears AUM’s Heart Sound Monitoring Devices

AUM Cardiovascular secured clearance from the FDA for its new non-invasive acoustic and ECG device.

The CADence device is designed to track pathological and physiological heart murmurs. It records sounds originating in the heart to determine patients’ cardiovascular health.

The device is now available in the United States, and AUM is currently seeking clearance to market the device for detection of coronary artery disease.

Allergan IUD Gets FDA Nod for Extended Use

The FDA approved a supplemental NDA to extend the duration of use for Allergan’s intrauterine device Liletta. Under the new approval, the levonorgestrel-releasing IUD’s duration of use is extended up to four years. The device was first approved in February 2015.

FDA Clears In2Bones Foot Repair Systems

French devicemaker In2Bones secured FDA clearance for two of its orthopedic repair systems.

The agency cleared the 5MS Fracture repair and CoLag locking compression screw system. The repair system treats deformities and fractures of the fifth metatarsal bone while the CoLag system improves compression and helps heal fragments and fractures.

Fifth metatarsal fractures are the most common for athletes.