Companies

Stryker has undertaken a voluntarily global recall for its Rejuvenate and ABG II modular-neck stems because of post-marketing surveillance data which suggests a potential risk of what it has termed “fretting and corrosion”.

New Sorin study evaluates sensitivity and positive predictive value of Sleep Apnea Monitoring (SAM) feature in implantable pacemakers.

UK competent authority the MHRA has issued a Medical Device Alert pertaining to Baxter’s Flogard and Colleague infusion pumps, one lot of which may have been incorrectly assembled.

Ethicon has issued a dire warning about inappropriate use of its Evicel® spray applicator, which raises the question of how well important information like this gets distributed outside US.

Abbott has announced that it has expanded its Healon® family of ophthalmic viscosurgical devices (OVDs) with the FDA approval of Healon EndoCoat OVD, a device intended for use as a surgical aid in cataract extraction and intraocular lens (IOL) implantation.

Wright Medical Group, Inc. has announced the full commercial launch of the ORTHOLOC™ 3Di Reconstruction Plating System for foot and ankle surgery. The system is to be made available this month in both the U.S. and international markets.

Sorin group is to acquire CalMed, Californian manufacturer of cardiovascular cannulae, in a move which will enhance the Italian company’s offering.

According to a press release issued by US Law firm Bernstein Liebhard LLP, FDA has received almost 17,000 adverse event reports from 2000-2011, associated with metal hip implants, such as the DePuy ASR and Pinnacle hip systems. An FDA panel has been in session for two days to discuss the situation.

A new technique involving retrograde endovascular approach to occluded peripheral arteries shows promise, but hasn’t yet been formally studied. Cook Medical is supporting a multicentre effort to build an evidence base for what could be a promising solution to the major healthcare problems resulting from peripheral artery disease.

The life of a medtech company is never straightforward is it? Just as Medtronic is celebrating victory in a stent graft patent case involving W.L.Gore it also emerges that it is being sued for historical royalty payments of at least $7M, which a University claims it is due because of confusing accounting practices.

Corin Group must be doing something right for LARS SA to extend its distribution agreement with the company in terms of both time and territories. Most notably the new deal now encompasses USA, subject to Corin handling the 510(k) submission.

Covidien has been on the unpleasant end of FDA’s big stick, the agency having written to the company about a raft of areas in which it has found the handling of the Duet TRS stapler recall to be inadequate.

Zimmer’s unique trabecular metal spinal implants are being introduced both sides of the pond as the company seems keen to exploit its promising technology.

Can the colour of your intraocular lenses affect your circadian rhythm and general health? Really? Our disbelief is suspended temporarily as Abbott Medical cites clinical evidence that it can.

Covidien’s acquisition of Oridion Systems Ltd. is complete, expanding the medtech giant’s portfolio of key monitoring technology to include the Israeli company’s capability in airway management.

Surgical Innovations Group plc, and CareFusion Inc. have agreed an eight year exclusive US distribution agreement for SI’s clever PretzelFlex® laparoscopic retractor.