FDA clears Israel’s UpnRide wheelchair, Apifix spine device gets humanitarian status, Startup’s smartphone CKD diagnosis approved, and much more!

by Michael Ordman

ISRAEL’S MEDICAL ACHIEVEMENTS

US approval for upright wheelchair

I’ve reported previously (see here) about Israel’s UPnRIDE robotic standing wheelchair that allows wheelchair users to travel upright. The US FDA has just cleared the UPnRIDE for marketing and use in the US. Cofounder Dr Amit Goffer is a quadriplegic who uses the UPnRIDE himself.
https://en.globes.co.il/en/article-upnride-standing-wheelchair-receives-fda-clearance-1001301453

Spine device gets humanitarian status

I reported previously (see here) on the twisted spine treatment from Israel’s Apifix. The U.S. FDA has given Humanitarian Device Exemption (HDE) to Apifix to market its MID-C system. Apifix addresses the unmet clinical need for an alternative to spinal fusion.
https://www.businesswire.com/news/home/20190827005604/en/ApiFix-Receives-FDA-Approval-Commercialize-MID-C-System

Smartphone CKD diagnosis approved

I’ve reported previously (see here) on Israel’s Healthy.io and its smartphone-based urinalysis for Chronic Kidney Disease. It is now US and EU approved and some 100,000 kits have been sold. Healthy.io has just raised $60 million of funds. https://healthy.io/about-us/
https://vimeo.com/200176528 (UK Financial Times video)

 

Heart implant is a breakthrough (twice)

I reported previously (see here) on the interatrial shunt developed by Israel’s V-Wave. The US FDA has just granted two Breakthrough Device Designations to the device – the first is for Heart Failure (HF), and the second, for Pulmonary Arterial Hypertension (PAH).
http://vwavemedical.com/2019/09/12/v-wave-receives-second-fda-breakthrough-device-designation-interatrial-shunt-for-pulmonary-arterial-hypertension/

FDA approves diabetes management system

I’ve reported previously (see here) on the diabetes monitors from Israel’s DreaMed. The US FDA has just given approval to DreaMed’s Advisor Pro, to add to its EU approval. The software tells Type 1 diabetics how much insulin to use, without having to contact a physician.
https://www.jpost.com/Israel-News/DreaMed-wins-FDA-clearance-for-AI-insulin-recommendation-technology-601846

US approval for ultrasound skin tightening

I recently reported (20th Aug) that Israel’s SofWave had received CE certification for its non-invasive ultrasound technology for skin tightening. It has now also received FDA approval. 86% of a recent trial demonstrated improvement in wrinkle appearance.
https://www.prnewswire.com/news-releases/sofwave-medicals-low-divergence-ultrasound-technology-has-received-fda-clearance-for-the-aesthetic-treatment-of-facial-lines-and-wrinkles-300918611.html

US approval for lung diagnosis catheter

I reported previously (May 2017) on Israel’s Body Vision Medical when it was producing hi-res maps of the lungs to aid tumor removal. Since then it has developed a disposable lung navigation catheter which recently received US FDA approval. The company has also raised $20 million.
https://www.calcalistech.com/ctech/articles/0,7340,L-3771163,00.html

EU funds heart protection device

Israeli startup Filterlex Medical has received 2.1 million euros from the European Union’s Horizon 2020 research and innovation program. Filterlex develops an embolic protection device to reduce the risk of stroke and other complications during catheter-based heart procedures.
https://www.calcalistech.com/ctech/articles/0,7340,L-3770877,00.html http://filterlex.com/

Treatments for eye diseases

Israeli biotech Wize Pharma markets Israeli-developed LO2A eye drops for the treatment of ophthalmic disorders, including Dry Eye Syndrome. Wize is now to develop and trial the WP-REP1 gene therapy from Cleveland’s Copernicus for treating the rare eye disease Choroideremia.
http://wizepharma.investorroom.com/2019-09-09-Wize-Pharma-Enters-Exclusive-License-Agreement-for-Ophthalmic-Non-viral-Gene-Therapy-Technology https://www.wizepharma.com/lo2a-eye-drops

Innovative infusion systems

The infusion systems of Israel’s Eitan Group (Q-core, Sorrel and Avoset), are installed worldwide. E.g. there are 100,000 of Q-cores Sapphire devices in the market. Eitan has now agreed that Canadian Hospital Specialties will supply and support Sapphire across Canada.
https://www.massdevice.com/how-the-eitan-group-aims-to-disrupt-the-infusion-pump-industry/
https://www.prnewswire.com/news-releases/canadian-hospital-specialties-to-distribute-eitan-groups-sapphire-infusion-systems-in-canada-300918470.html

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