Technology

Cyberonics, Inc. has gained CE Mark approval for its AspireSR generator, the novel sixth-generation Vagus Nerve Stimulation (VNS) Therapy generator.

Parametric Sound Corporation, a leading innovator of audio products and solutions, has received U.S. FDA clearance for the marketing of its HyperSound® Audio System as a hearing improvement device.

ReCor Medical’s Paradise Renal Denervation System uses ultrasound energy to do the job, compared with the RF used by its major competitors. In the wake of Symplicity HTN-3’s poor results, ReCor is keen to put some fresh air between its approach and that of the opposition, pointing to favourable outcomes in patients who had already been treated with RF energy.

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.

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.

UK wound healing expert company Tissue Regenix is planning to launch its biological scaffold product, DermaPure™, in early 2014 and is putting in place an extensive distribution network to make sure it gains appropriate coverage.

18 month efficacy and safety results from EnteroMedics, Inc.’s 5 year ReCharge Pivotal Trial of VBLOC® vagal blocking therapy for the treatment of obesity have been released. It seems it works, as the statistically significant results show.

The UK’s National Institute for Health and Care Excellence (NICE) is to start developing Medtech Innovation Briefings – a new product to support healthcare staff considering using new medical devices and other medical technologies.

Medtronic’s Activa® PC+S Deep Brain Stimulation System closes the loop in understanding the impact of this therapy, by monitoring the impact of the therapy on specific areas of the brain in real time.

Intuitive Surgical has written to customers worldwide, and in the US the FDA has issued a Class II recall notice which contains the instruction that users should contact the company to arrange an inspection visit and repair or replace daVinci robotic surgery device components as necessary to avoid a friction-induced stalling problem.

Law firm Bernstein Liebhard LLP has issued a press release that brings us up to date, pointing in particular to a piece of research that suggests 30% of robotic surgery complications using Intuitive’s da Vinci system, as reported on the FDA’s MAUDE database, were either a result of operator error or technical failure of the robotic system itself.

Toshiba Medical Systems has issued a press release to remind us of the merits of its Pianissimo™ Magnetic Resonance System, which it claims reduced acoustic noise associated with MRI scanning by up to 90% or 33dB(A).

The annual medtechfest that is the Medica exhibition takes place next week, so expect a few press releases from companies eager to attract the attention of visitor and browser alike. One such, OJBio Ltd., will be using attendance at Medica to showcase the latest developments in its biosensor platform technology for the rapid point of care diagnosis of infectious diseases.

Medical imaging company Paxeramed has launched the industry’s first medical imaging sharing module to social media. The module anonymizes selected CT, MRI and X-Ray images and allows users to share it to social-media platforms from their reading workstations or dedicated viewing apps.
Platforms like Facebook and Twitter allow the shared images to be uploaded to private healthcare and hospital social media groups in a secure and HIPAA compliant manner.

A new case study, published in the New England Journal of Medicine, highlights unprecedented technology for lower-limb amputees who could theoretically soon benefit from thought-controlled bionic limbs.

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.