Regulatory

Boston Scientific Corporation has announced the FDA clearance for an expanded use indication for the CRE™ Wireguided Balloon Dilator for endoscopic dilation of the Sphincter of Oddi following sphincterotomy, quite literally opening up the possibility of using it for dilation assisted stone removal.

While we’d all have preferred not to have seen the recent PIP/Hip problems, there’s no doubt in our mind that the hubbub presents a unique opportunity to adopt measures that could show the world how to do this stuff.

UK Competent Authority on Medical Devices, the MHRA has issued a medical device alert relating to Nottingham-based Capatex Medical’s Endotracheal tube clamps which it says may result in a risk of airway loss due to slippage or airway obstruction, as a result of over-tightening of the clamp/holder.

When a pioneering surgeon is sat on the same table as an advocate of evidence-based medicine and greater regulatory controls, it’s easy enough to predict that their views might not align perfectly. So it was with the holding of a UK Parliamentary Select committee on medical devices regulation, held last Wednesday.

When medical device regulation reaches you in Malaysia you know it’s time to comply as failure to do so can result in a juicy fine or a holiday in the “big house”, or both. It’s interesting to see their interpretation of effective regulatory requirements adopting a risk-based and evidence-based approach.

Bioptigen Inc. has received FDA 510(k) clearance to begin marketing its hand-held Envisu Spectral Domain Ophthalmic Imaging System (SDOIS) for patient use. In receiving this regulatory clearance, Bioptigen’s Envisu SDOIS become the first optical coherence tomography(OCT) imaging system commercially available in the United States for hand-held and paediatric imaging.

Covidien’s quietly recalling its Roticulators for packaging concerns, but seems to be doing so by stealth rather than adopting the slightly more communicative route one might expect to see.

Minnesota based Nonin Medical, Inc., has announced FDA 510(k) clearance and commercial release with expanded labelling claims for its Onyx® Vantage 9590 professional fingertip pulse oximeter.

The UK Commons select committee on science and technology is meeting tomorrow (Wednesday 23rd May) to explore how to ensure the safety of medical implants before they enter the market, and how best to collect clinical data once an implant is in use, from the perspective of clinicians, patients and scientists.

Consumers union is bent on regulatory tightening and even resorting to print ads in its quest to convince Joe Public that the evil medical device manufacturers are trying to harm him. One wonders whether they have the right objective in mind though because the regulatory regime they might end up with could actually stifle innovation and be more harm to Joe Public than the present set-up.

This clever device from ApniCure Inc., gets around the need for a mask in treating sleep apnea, by employing a soft mouthpiece which together with a vacuum created by the device pulls the palate forward and stabilises the tongue. FDA agrees and has cleared the device under its 510(k) regulations.

It’s been a fascinatingly diverse week with a steady flow of medical device news. It’s notably been a week containing a cardiovascular congress in Paris (EuroPCR) and an arthroscopy congress in Orlando (AANA). Anyway, it’s online right now.

State of the art materials lie at the heart of this incredibly liberating exoskeleton for people with spinal cord injuries. The definition of a medical device, for CE mark purposes stretches from cranberry pills to exoskeletons it seems as Ekso Bionics announces gaining of clearance to market in Europe.

Covalon’s IV Clear™ Silicone dressing is comfortable to wear and remove and contains two antimicrobial components within its adhesive layer, making it a compelling proposition in the market for securement of such as IV access devices. Now the product has FDA clearance to add to its Health Canada approval.

Hydrogel sealants have a habit of clogging in their applicator nozzles, a problem Hyperbranch reckon they’ve solved with their newly CE marked Adherus™ Autospray device.

An interesting read for anyone involved in medical devices. It’s perhaps unsurprising to see the data which after all only supports what we’ve seen… a series of high profile problems resulting in more than twice the number of recalls during Q1 than in the previous period.