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FDA Clears Medtronic SHILLA™ Growth Guidance System

Medtronic has gained U.S. FDA 510(k) clearance for its SHILLA™ Growth Guidance System, designed to treat spinal deformities in skeletally immature pediatric patients with severe, progressive, life-threatening, early-onset spinal deformities.


FDA 510(k) Clearance for CardiacAssist’s PROTEK Duo™ Veno-Venous Cannula

Newly cleared PROTEK Duo™ veno-venous cannula is intended for use as a single cannula for both venous drainage and reinfusion of blood via an internal jugular vein during extracorporeal life support procedures.

Ethicon Unveils Expanded Bariatric Surgery Portfolio at IFSO 2014

Headline imageEthicon is introducing three new endocutter and energy products at the 19th World Congress of International Federation for the Surgery of Obesity & Metabolic Disorders (IFSO 2014).

Medtronic Bolts on Sapiens Steering Brain Stimulation for $200 Million

Medtech Titan Medtronic has acquired Dutch Neuro device developer and its novel Deep Brain Stimulation system

New Money Will Get Claret’s Sentinel™ Stroke Protection Device Through Study

It's full steam ahead for Claret Medical as it announces Series B financing that will take it a long way down the road to US FDA approval, assuming its pivotal study goes to plan.

Cook Medical Recalls CloverSnare™ 4-Loop Vascular Retrieval Snare

Cook Medical has initiated a recall of 696 of its CloverSnare™ 4-Loop Vascular Retrieval Snare devices because of a potential for device failure with serious consequences.

Boston Scientific and ASAHI INTECC Join Forces on FFR Wire Project

Sounds like a plan. Combine the offerings of one of the Cardiovascular big boys with wire forming company's expertise and FFR technology is likely to benefit.

First Patient in Cook’s Zilver PTX Drug Stent Chinese Study

Headline imageCook's peripheral drug stent, the first of its kind in China, is being conducted at up to 20 clinical sites and will enroll 175 patients with one-year follow-up.

FDA Clears Premvia™ Hydrogel Scaffold for Regenerative Indications

BioTime, Inc. says its Premvia™ hydrogel tissue substitute has been cleared for marketing as a Class II medical device.

DePuy Synthes Craniomaxillofacial Distraction System Recall is Class I

When a device is relied on to provide distraction, it's obviously alarming when it has the potential to reverse direction. The consequences are significant enough to warrant the FDA classifying Depuy Synthes' recall as Class I.

FDA Clears CorMatrix® CanGaroo™ ECM® Envelope for Cardiac Implantables

Cormatrix's aptly named CanGaroo envelope (or pouch) offers a marsupialised approach to cardiac device implantation.

FDA Approval for Medtronic Viva® Cardiac Resynchronization Therapy-Pacemaker

CE marked earlier in the year, Medtronic's Viva CRT-P system will now be available for US patients following its newly announced FDA approval.

CE Mark for New Size of Direct Flow Transcatheter Valve Plus No Use of Contrast Media

Headline imageThis is big news for Direct Flow as it needed that 23mm option to open up a new patient cohort. The avoidance of contrast media is big for the company too.

Study Shows Remote Monitoring Reduces All-Cause Mortality by 50%

It might seem obvious that the heightened level of care provided by remote monitoring of cardiovascular conditions would result in only good things for patients. A new study, published in The Lancet, confirms it.

Device Sales Staff Could Face 20 Years for Defrauding Hospitals

Even with potential sentences of up to 20 years in the offing, it's still painful for the medical device industry to see its name being sullied by fraudulent actions of a few trusted individuals.

JenaValve Turns to Experience for New Chief Technology Officer

JenaValve isn't yet a household name in transcatheter aortic valve circles, but its new Chief Tech officer might just see that change.