Healthcare

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 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.

Diabetes solutions giant Novo Nordisk, has gained FDA approval for its pre-filled insulin pens which it says avoid the patient challenges presented by other pre-filled pens.

Device company Teleflex Inc., is heading East next week. The company says it will be presenting its newly designed systems for intermittent catheterization at the 52nd Annual Scientific Meeting of the ISCOS (International Spinal Cord Society) in Istanbul, Turkey on October 28-30, 2013.

The FDA has cleared Novo Nordisk’s novel NovoPen Echo, the first insulin injection device to combine half-unit dosing with a memory function to help patients better manage their diabetes

AngioDynamics, Inc. has announced the U.S. FDA 510(k) clearance through its subsidiary business Navilyst Medical Inc., for its BioFlo Port with Endexo technology, which is designed to reduce the accumulation of catheter-related thrombus on, and in, the port catheter.

Osiris Therapeutics, Inc., has reported results from its multi-center, randomized, controlled clinical trial comparing the safety and effectiveness of Grafix® to standard of care in patients with chronic diabetic foot ulcers. The Grafix group met the pre-specified stopping rules for overwhelming efficacy as determined by the data monitoring committee during a planned interim analysis.

The UK’s regulatory overlord, the MHRA has issued a device alert pertaining to CareFusion’s Alaris® GP, GP Guardrails®, GP Plus and GP Plus Guardrails Infusion pumps, product codes 80263UN01, 80263UN01-G, 9002MED01, 9002MED01-G

Monitoring specialist Ambio Health, has announced that its wireless remote health and activity monitoring tool, has received Class II FDA 510(k) Clearance.

A new report, entitled the 2013 Smart Pump/EMR Integration Report from KLAS Research cites CareFusion as the technology leader that is poised to take the lead in integrating smart pumps with electronic medical records (EMR) and the only company that currently has a customer using EMR interoperability with large volume and syringe infusion pumps.

GE Healthcare’s new digital mammography imaging technology is claimed to achieve results previously only attainable with higher X-ray doses. In addition it promises superior sensitivity and lesion margin specificity.

Remote Medical International launched RMI CONNECT, a global telemedicine service that provides integrated medical support.
Pitched at people working in far flung reaches of the world, the company says RMI CONNECT clients receive unlimited access to comprehensive medical advice and logistical support worldwide, 24 hours a day, 7 days a week, 365 days a year.

Preliminary second quarter figures from surgical robotics company Intuitive Surgical, Inc. are some way off the company’s predictions. Q2 projections included sales of over $620M, which would have been a 16%+ ramp, but actual sales came in at $575M, only a 7% increase over prior year.

CorMedix Inc. has gained CE Mark approval for Neutrolin®, a catheter lock solution for patients with central venous catheters on hemodialysis secondary to advanced chronic kidney disease.

Aethlon Medical, Inc. has announced that the U.S. FDA has approved an Investigational Device Exemption (IDE) that allows the Company to initiate human feasibility studies of the Aethlon Hemopurifier® in the country. The Hemopurifier targets the rapid elimination of life-threatening infectious disease and cancer glycopathogens from circulation.

Commentators on healthcare provision point to several factors that they say mean healthcare costs are inexorably rising. People living longer … continue reading “Medtech Europe Boss Challenges Link Between Technology Advances And Cost Increase”