Medical device news

ImpediMed [ASX: IPD] has received FDA clearance for the company's L-Dex U400 lymphoedema assessment device.

According to ImpediMed representatives, the company is now clear to launch the device onto the US market.

It will be marketed directly through ImpediMed's own US sales force, which will initially be targeting surgeons, oncologists and therapists.

A study of the PulmoTrack wheeze-monitoring device developed by KarmelSonix [ASX: KSX] has determined the device was better at detecting wheeze than a group of intensive care experts.

The study was conducted by Professor Natan Noviski at the paediatric intensive care unit at Boston's Massachusetts General Hospital.

Noviski determined that while physicians, nurses and respiratory therapists from the hospital were as good at detecting the absence of wheeze as PulmoTrack, the device's objective measurements could more accurately determine the presence of wheeze.

KarmelSonix also has been granted approval to conduct the first clinical trials of its Personal Wheezometer measuring device.

The study will be held at the Hillel Yafe Medical Center in Israel.

Nanosonics [ASX: NAN] has appointed distributors for its Trophon EPR ultrasound probe disinfector in Germany, France, Scandinavia and Switzerland.

It has also come to distribution agreements for Australia, New Zealand and Italy.

According to Nanosonics, the dealers were selected after a stringent vetting process which has been implemented worldwide.

With these European dealer contracts, Nanosonics have secured sales commitments that surpass its internal expectations.

The roll-out remains on track for an initial commercial launch for Australia and New Zealand in January next year.