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US Food and Drug Administration (FDA)

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2018
17 Sep

Nuvectra

Nuvectra is a bioelectronic medicine company which has developed a spinal cord stimulator for pain management. IDTechEx analyst Nadia Tsao interviewed Dan Froelich, Executive Director at Nuvectra, on 16 Aug 2018.
14 Sep

GiMer Medical

GiMer Medical is an electrical neuromodulation company based in Taiwan. IDTechEx analyst Nadia Tsao interviewed Tina Chang, Director of International Affairs, on 12 Sep 2018.
5 Sep

Avery Biomedical Devices

Avery Biomedical Devices is a medical device company that has been offering the diaphragm pacemaker since 1971. IDTechEx analyst Nadia Tsao interviewed Avery Biomedical Devices CSO Dr Dilys Gore on 15 Aug 2018.
28 Aug

Deep transcranial magnetic stimulation treatment receives clearance

BrainsWay Ltd announces that it has received De Novo clearance from the U.S. Food and Drug Administration for its deep transcranial magnetic stimulation system for the treatment of obsessive-compulsive disorder in adults.
21 Aug

New clinical grade non transfusable products

StemExpress announces the release of Clinical Grade Non-Transfusable products to customers developing studies relating to transplantation, cell therapy, regenerative medicine, investigational new drug development, and the research and development of medical devices in preclinical and clinical phases.
17 Aug

Stimwave

Stimwave is a medical device company developing bioelectronic medicine. They have developed a wireless neuromodulator platform for pain management.
17 Aug

FirstKind Ltd.

FirstKind, a subsidiary of Sky Medical Technology, is a medical device company based in the UK that has developed a neuromuscular electrical stimulation device for the prevention of venous thromboembolism and for the enhancement of wound healing.
15 Aug

Nexeon MedSystems

Nexeon MedSystems is a bioelectronic medicine company developing medical devices for the treatment of movement disorders.
15 Aug

Parasym Health

Parasym Health is a bioelectronic medicine company based in the UK. They have developed a device for the treatment for tinnitus.
10 Aug

Next gen nVNS therapy available for patients with migraine in the USA

electroCore, Inc announced gammaCore Sapphire, the next generation of gammaCore (non-invasive vagus nerve stimulator or nVNS), is now available in the United States. gammaCore is the first U.S. Food and Drug Administration cleared, nVNS device for the acute treatment of pain associated with migraine and episodic cluster headache.
31 Jul

LifeSignals announces FDA Clearance

LifeSignals received FDA clearance for its wireless LP1100 Life Signal Patch for enabling the next generation of wearable, healthcare monitoring devices.
23 Jul

Magnetized wire could be used to detect cancer in people

Scientists at Stanford used the wire to capture free-floating tumor cells in the blood, a technique that soon could be used in humans to yield an earlier cancer diagnosis.
23 Jul

Blue Spark Technologies

Batteries from Blue Spark Technologies are being used in sensor based and battery assisted passive (BAP) RFID labels, in addition to powered cosmetic patches. Recent innovations include a new printed zinc anode.
20 Jul

Mobile health devices diagnose hidden heart condition

Wearable mobile health devices improved the rate of diagnosis of a dangerous and often hidden heart condition called atrial fibrillation, according to a first of its kind, home-based clinical study conducted in part by researchers at the Scripps Translational Science Institute.
17 Jul

Kite Pharma (Gilead Sciences)

Kite Pharma, now a subsidiary of Gilead, is a biotechnology company focused on curing cancer.
17 Jul

Spark Therapeutics

Spark Therapeutics was founded in 2013 and has access to over 2 decades of research and development from the Children's Hospital of Philadelphia.
16 Jul

Computer models could replace animal testing

A study suggests that advanced algorithms working from large chemical databases can predict a new chemical's toxicity better than standard animal tests. The computer-based approach could replace many animal tests commonly used during consumer product testing. It could also evaluate more chemicals than animal testing, a change that could lead to wider safety assessments.
12 Jul

3D printed membranes have faster water flow than conventional filters

A 3D-printing facility to manufacture a new type of water treatment membrane. Unlike conventional membrane-manufacturing processes that use acids to make polymers porous that function as filters, Nano Sun 3D-prints millions of nanofibers layered on top of each other, compressed into a thin membrane.
20 Jun

Preparing for the surgical robot boom

With greater investment from healthcare organisations and surgical robot technology about to become generic, the conditions are perfect for a boom in the surgical robotics market. But how can design engineers and technical medical staff ensure these new systems operate reliably and safely?
19 Jun

RxFunction Inc, creators of walkasins, hires new CFO

Mary E. Anderson is the new Chief Financial Officer of RxFunction, Inc., a start-up medical device company that created walkasins® - the first Wearable Sensory Prosthesis (WSP™) - to help improve balance and gait in patients who experience balance problems due to sensory peripheral neuropathy.
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