Companies

Ventricular Assist Device company, HeartWare International, Inc., says it expects revenues for Q4 2013 to be approximately $53 million, bringing expected full-year 2013 revenues to approximately $208 million. This represents 87% revenue growth over prior year, signalling a strongly upward trajectory for the company.

Endovascular robot company Hansen Medical met its 2013 outlook for commercialization of systems and estimated procedures. Furthermore the company added two hospitals to its roster of Magellan Centers of Excellence in the U.S. for the training of physicians and medical staff.

Preliminary unaudited financial results that suggest 2013 sales were up 4% compared with 2012, despite US system sales declining from 620 in 2012 to 546 in 2013. It seems procedure volumes and increased system sales outside the US give reason for good cheer.

Renal denervation therapy has had a bad day with the news that the biggest study and first to be sham-controlled, has not delivered its primary efficacy endpoints. Consequences for Medtronic’s Symplicity programme are serious enough for the company to be considering incurring an impairment charge.

Stryker Corporation and NeuroLogica have entered into an exclusive partnership agreement under which Stryker will promote and sell NeuroLogica’s BodyTom portable full body computed tomography (CT) scanner for the specialties of neurosurgery, spine surgery, orthopaedic surgery, and trauma surgery in conjunction with the Stryker NAV3i™ Surgical Navigation Platform.

CareFusion has completed the acquisition of Vital Signs from GE healthcare in the U.S., China and certain other geographies.

We’ve covered TYRX’s clever antibacterial, FDA cleared, device envelopes before, mainly because it’s an interesting concept. Medtronic thinks so… it likes it so much it’s bought the company.

Stryker Corporation is to acquire Patient Safety Technologies, Inc. for an aggregate purchase price of $120 million. Patient Safety Technologies conducts its business through its wholly owned subsidiary, SurgiCount Medical, Inc. The transaction is expected to close in the first quarter of 2014.

The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has issued a device alert relating to certain lots of OPTEASE® retrievable vena cava filter, manufactured by J&J’s Cordis Corporation.

InVivo Therapeutics Holdings Corporation has appointed Mark D. Perrin as its Chief Executive Officer. His first day at work will be Monday January 6th, at which time, Mr. Perrin will also become a member of the company’s Board of Directors.

Afib device specialist AtriCure, Inc., has entered into a definitive merger agreement with Endoscopic Technologies, Inc. d/b/a Estech (“Estech”). AtriCure … continue reading “AtriCure Brings Estech into the Fold”

Baxter International Inc. has gained CE mark approval for its VIVIA hemodialysis (HD) system, designed to deliver more frequent, extended duration, short daily or nocturnal home HD therapy, known as High Dose HD therapy.

According to a well-known Berlin cardiologist, monitoring devices enable physicians to treat patients more effectively. The BioMonitor from BIOTRONIK is now approved for full-body MR scans.

Medtronic, Inc., has kicked off its SYMPLICITY HTN-4 study with the news that the first patients have been randomized. The study, which started enrolling in November 2013 will evaluate the Symplicity™ renal denervation system in patients with moderate uncontrolled hypertension

Boston Scientific has received CE Mark approval of its X4 line of quadripolar cardiac resynchronization therapy defibrillator (CRT-D) systems and seen first implantations in Italy.

DePuy Synthes Trauma has announced the U.S. launch of a new Radial Head Prosthesis System for primary and revision joint replacement of the radial head to restore joint function.