Approvals
Gastrointestinal Pathogen System Receives CE Mark
Applied BioCode’s MDx3000 gastrointestinal pathogen testing system received a CE Mark, allowing its distribution in Europe.
The MDx3000 automates the PCR amplification, hybridization and detection steps of molecular testing and can process up to 3,384 results in an 8-hour shift.
The system can process up to 3 different assay panels in the same session and can mask any test results within individual panels for tests not ordered by the patient.
Materialise Cleared for 3D Modeling Software
The FDA granted 510(k) clearance for Materialise’s Mimics inPrint Software, which is used to create 3D anatomical models from medical image data.
The software outputs the models to a 3D printer at the point-of-care and is used to assist practitioners with consultation, patient diagnostics and planning for complex surgeries.
It is also used to enhance education and communication with the patient and between multidisciplinary teams.
Shockwave Wins CE Mark for Low-Profile Catheter
Shockwave Medical’s Shockwave S4 peripheral intravascular lithotripsy catheter, used for treating calcified lesions in below-the-knee arteries, won a CE Mark.
The device uses sound waves to break up calcified lesions blocking vessels and is designed to minimize trauma to the artery.
The S4 includes a battery-powered generator and hand-held connector cable, as well as a catheter which houses the sonic emitters within an integrated balloon.
Sandstone Diagnostics’ Trak Volume Cup Cleared by FDA
The FDA gave 510(k) clearance for Sandstone Diagnostics’ Trak volume cup, a new addition to its Trak male fertility testing system.
The volume cup allows patients to measure their semen volume and diagnose hypospermia.
The cup is coated with a liquefaction enzyme that breaks down sample viscosity and allows the user to funnel the sample into a graduate measurement compartment for an accurate reading of semen volume.
FDA Expands Indication for Drug-Coated Balloon
The FDA approved Medtronic’s In.Pact Admiral drug-coated balloon for treating long superficial artery lesions in patients with peripheral artery disease.
The approval was based on data from complex lesion imaging cohorts from the company’s global study.
The device can treat lesions up to 360mm and is suitable for treating lesions beyond 180mm, frequently involving in-stent restenosis and chronic total occlusions.
Blink’s Neuromuscular Monitor Receives 510(k) Clearance
Seattle-based startup Blink Device Company received marketing clearance for its TwitchView monitor for neuromuscular blockade.
TwitchView is the first standalone electromyographic based monitor in the United States, according to the company. The quantitative monitor functions accurately regardless of patient positioning.
Elise Hyman, a former director at GE Healthcare specializing in perioperative care, is leading Blink’s marketing and sales.
FDA Grants Clearance for Multi-Purpose Digital Imaging System
The FDA gave 510(k) clearance to Agfa for its Dr 800 multi-purpose digital imaging system, which covers radiography, fluoroscopy and advanced clinical applications.
The device comes with Dynamic Musica software that enhances noise suppression, brightness control and veiling glare reduction.
The device can handle a full range of radiography, including static exams and tilting exams, and fluoroscopy exams, including barium studies, arthrograms, cystograms, myelography and catheter placement.
Tandem Diabetes Care Gets CE Mark for Insulin Pump
A San Diego medical device company, Tandem Diabetes Care, received a CE Mark for its t:slim X2 insulin pump with Dexcom G5 mobile continuous glucose monitoring (CGM).
The device includes a large color touchscreen, watertight construction, USB connectivity and a rechargeable battery. It is the first CGM-enabled pump that lets users make treatment decisions without pricking their finger.
The company plans to launch the pump commercially in select global markets in the second half of 2018.