Approvals

Avinger Image-Guided Atherectomy Device Gets CE Mark

Avinger received a CE Mark for its image-guided Pantheris Lumivascular atherectomy system for treatment of peripheral artery disease.

The new device features a simplified single balloon system for the occlusion of blood flow and device positioning, the company said. It enables surgeons performing atherectomy to see from inside the artery during the procedure via Avinger’s Lightbox console instead of using x-rays.

FDA Clears Spectral Medical Stand-Alone Pump

The FDA granted 510(k) clearance to Spectral Medical’s Spectral Apheresis machine for use in therapeutic plasma exchange and continuous renal replacement therapy.

The stand-alone pump was initially developed for use in intensive care units to septic shock patients without requiring third-party CRRT machines.

The company said it will seek clearance for use of the Apheresis as an open platform hemoperfusion delivery device once an FDA-approved hemoperfusion cartridge is available on the market.

FDA Clears Biotricity ECG Remote Monitoring Device

Medical diagnostic firm Biotricity received 510(k) marketing clearance for Bioflux, its ECG remote monitoring device.

The device detects and transmits diagnostic heart information, including probable arrhythmias, to physicians to allow for remote monitoring and diagnosing of patients with cardiovascular coronary heart disease.

Shire Web-Based Dosing Software Achieves FDA Clearance

Shire received 510(k) marketing clearance for its web-based dosing software for patients with hemophilia A treated with ADVATE.

The mPKFit estimates a patient’s pharmacokinetic profile using just two measurable blood samples — compared to the 9 to 11 samples recommended by the International Society on Thrombosis and Haemostasis — enabling clinicians to tailor treatments to the individual patients.

The severity of hemophilia A is determined by assessing the amount of factor in the blood, with more severity associated with lower amounts of factor.

Prescient Surgical Scores FDA Clearance for Wound Retraction and Protection System

The FDA cleared Prescient Surgical’s CleanCision wound retraction and protection system for use in abdominal surgery.

Developed by surgeons and infection control experts, the device combines wound protection and irrigation with an easy-to-use retraction system.

The system features active cleansing technology to continuously suction harmful bacteria from an incision throughout a surgical procedure to help prevent contamination of the wound.

Sanuwave’s Diabetic Foot Ulcer Device Gets FDA Marketing Clearance

The FDA signed off on marketing authorization for Sanuwave’s Dermapace system, a shockwave device used to treat diabetic foot ulcers. The system uses energy pulses to mechanically stimulate wounds in adult patients whose ulcers last longer than 30 days.

The agency based the approval on clinical data from two multi-center studies with a total of 336 patients.

Abbott Gets CE Mark for Alinity Hematology Testing System

Abbott received a CE Mark for its Alinity h-series hematology testing system.

The solution is intended to be combined for use with the Alinity hq standalone hematology analyzer.

Its reagent bottles were designed “to work like a lock and key to ensure that the right reagents can only be inserted into the right location, preventing costly mistakes and time delays in the lab,” the company said.