Regulatory

While the toxicology work continues, it seems implant data is still saying the same thing, that PIP implants rupture more frequently than other implants, that in most cases there is no reaction, and when there is a reaction it’s obvious. Most significantly data confirms no resultant cancer.

Edwards Lifesciences was not likely to let a BMJ article go unanswered, so it’s unsurprising to see the purveyor of the Sapien transcatheter valve issuing a stout defence of the clinical evidence behind its baby. But as a clinician, what are you supposed to do?… wait until the body of evidence is so significant as to be incontrovertible, or use your own judgement within the confines of regulatory approval?

Belgian researchers have stirred up a hornets nest with their assertion that evidence for TAVI means its use should be more limited than is the case, and furthermore that we’re still not getting the whole picture.

Covidien has announced FDA 510(k) clearance to market its Covidien Nellcor™ Bedside SpO2 Patient Monitoring System.

Teleflex Incorporated has announced that its Semprus BioSciences subsidiary has gained CE mark for its Nylus™ Peripherally Inserted Central Catheter with Semprus Sustain™ technology.

FDA has issued a Class I recall notice relating to Teleflex subsidiary Arrow International’s Multi-Lumen Venous Catheterisation Set, following the company’s May Field Corrective Action Letter.

Boston Scientific Corporation has received CE Mark approval for use of its MRI compatible INGENIO™ and ADVANTIO™ pacemakers

Medtronic, Inc. has announced the FDA 510(k) clearance for its Aquamantys®3 BSC 9.1S Bipolar Sealer with Cutting, a new addition to the orthopaedic portfolio of the company’s Advanced Energy business. Combining sealing with cutting in a single device should make procedures more efficient, according to the company.

Sunshine Heart, Inc. has received CE Mark approval for its C-Pulse Heart Assist System for the treatment of Class III and ambulatory Class IV heart failure.

Vascular robotics company Corindus Vascular Robotics, has announced FDA 510(k) clearance has been granted for its CorPath 200 System to be used in percutaneous coronary interventions (PCI).

Siemens Healthcare has announced that its MAGNETOM Spectra 3 Tesla MRI system has received US FDA clearance. The company believes it has achieved the optimal blend of reduced ownership costs, excellent image quality and rapid scan times with this system which it says provides hospitals and radiological institutes with easier access to 3T technology.

UK’s regulatory authority the MHRA has issued a Medical Device Alert(MDA) pertaining to all lot numbers and product codes of the EMS ET Tube Clamp/Holder because of a risk of airway loss due to slippage of the clamp/holder or airway obstruction as a result of over-tightening of the clamp/holder.

Nice product, well done for the CE Mark, but should Lazarus Effect be issuing a press release when it’s website’s not even finished? As medtech marketers we’re stumped why anyone would do that.

Another in a long line of Californian medtech start-ups, Blockade Medical™ has announced the gaining of CE Mark status for its Barricade Coil System™, designed to remove or endovascularly occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.

There’s no stopping Covidien’ s neurovascular clot retrieval device, which the company has announced can now add Brazil to Europe and USA as territories wher eit is approved for sale.

Retinal prosthesis pioneer company Second Sight Medical Products Inc., has announced that a U.S. FDA Ophthalmic Devices Advisory Panel will take place on September 28th to review the company’s Humanitarian Device Exemption (HDE) market approval application for its Argus II Retinal Prosthesis System (Argus II prosthesis).