Regulatory

Binder Biomedical Inc. has announced that its new LOGIC intervertebral body fusion device has been cleared by the FDA. The complete anterior lumbar fixation system will see its initial launch early next year.

Zilico Ltd has gained CE Mark certification for its cervical cancer diagnostics device, ZedScan™ I. The UK company’s ground-breaking system offers quick, accurate detection of cervical neoplasia in real-time, enabling clinicians to improve patient management.

OrthoSensor™ has announced plans to launch its Verasense™ Knee System in European markets after recently receiving CE Mark approval. Verasense is the first integrated intelligent orthopaedic device to provide surgeons with real-time quantitative data on knee implant positioning, limb alignment and soft tissue balance during total knee replacement surgery.

Medtronic, Inc., a world leading spinal technology company, has taken the opportunity presented by two big spinal congresses to announce the CE marking and European launch of a new cervical cage system which expands the successful Compact CORNERSTONE-SR® platform of cages.

Californian spinal technology company DFINE, Inc., has now received CE Mark approval for its STAR™ Tumor Ablation System for treatment of painful metastatic spinal tumors. The company officially launched the system in Europe at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) Annual Congress last month.

Heart rhythm and home monitoring specialist Biotronik, has gained FDA approval for its Ilesto family of implantable cardioverter-defibrillator/cardiac resynchronization therapy defibrillators (ICD/CRT-D) devices.

Medtech industry is focused on the significant matter of the punitive and unfair sales tax. Companies would do well to stop taking EU market access for granted though, as new rules will slow things down and increase costs to beyond FDA levels. This is serious.

Following the announcement of the FDA clearance of NeoTract’s UroLift® System for treating symptoms of benign prostatic hyperplasia, the company has issued a press release confirming that a first patient has now undergone treatment with the device.

Oh dear, medtech industry body is really not sounding happy at the European Parliaments rushed through rule changes. And when they point to the huge cost and delay to market that will result from a bureaucratic behemoth, who are we to argue?

It’s a clever concept, the idea that by doing some assembly at the surgical site the physician can avoid large incisions. Vertebral Technologies’ newly FDA cleared system permits a large lumbar interbody fusion using a minimally invasive approach.

Peripheral Vascular Stent options in the US now include Medtronic’s Complete SE offering which has seen its indication extended to include the superficial femoral and proximal popliteal vessels.

Small bowel disease, including Crohn’s, is now within the diagnostic grasp of Gastrointestinal physicians in Japan with the news that Given Imaging’s optimised SB3 PillCam has been approved for market release. Sales will start in 2014.

Edwards Lifesciences’ FDA approval for its Sapien Transcatheter Heart Valve was originally limited to transfemoral or transapical access. Now the access point restriction has been lifted, based on clinical registry data. Whether this opens up the patient population remains to be seen.

Sapheon Inc. has submitted the first module of the pre-market approval application for the VenaSeal® Sapheon Closure System to the U.S. FDA. Sapheon expects to be launching its product in the first half of 2015.

Ocular Therapeutix, developer of hydrogel based sealant technology for use in ophthalmic cases, has received a guarded nod from the FDA’s review panel.

NeoTract, Inc., has received De Novo approval from the U.S. FDA to market the novel UroLift® System, the first permanent implant to relieve low or blocked urine flow in men age 50 and older with Benign Prostatic Hyperplasia, also known as enlarged prostate.