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US Food and Drug Administration (FDA)

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2018
13 Dec

Growing skin in the lab for the treatment of advanced wounds

Though there are many medical devices that can be used in the care of advanced wounds, there is significant clinical research to support that biological therapies provide superior healing ability.
26 Nov

Stratasys and Materialise: 3D printed medical models come to life

Further bringing 3D printed medical models to life, Stratasys is expanding the suite of printers and materials validated by its collaborator Materialise as part of FDA-cleared Materialise Mimics inPrint software. The end result is the most versatile 3D printing system for point-of-care across hospitals and physicians - advancing production of patient-specific, life-like anatomical models for diagnostic purposes in conjunction with other tools and expert clinical judgement.
22 Nov

Johnson & Johnson

IDTechEx attended a presentation by Ajay Khatri, Director, Venture Investments at Johnson & Johnson Innovation at Medical MEMS & Sensors 2018.
22 Nov

Prosthetic system allows user to feel again

A new prosthetic hand system with a fully implanted, wirelessly controlled neurostimulator that has restored "feeling" to a person with a hand amputation.
19 Nov

Nyxoah Raises €15 Million in New Financing

Nyxoah S.A is focused on the development and commercialization of a best-in-class hypoglossal nerve stimulation therapy for the treatment of Obstructive Sleep Apnea and has successfully raised an additional €15 million in their most recent round of equity financing.
14 Nov

Dimension Inx

Dimension Inx is a 3D printing materials company with a focus biomedical applications. IDTechEx analyst Nadia Tsao interviewed Dimension Inx co-founders Dr Ramille Shah and Dr Adam Jakus on 23 Oct 2018.
14 Nov

Electrical stimulation could cure digestive disorders

More than 60 million people in the U.S. suffer from disorders in the gastrointestinal tract that could be cured by electrical stimulation, but scientists don't fully understand the therapy's effects on a critical organ: the stomach.
12 Nov

Stanford, Apple describe heart study with over 400,000 participants

Over 400,000 people have enrolled in a study being conducted by researchers at Stanford and Apple to determine whether a wearable technology can identify irregular heart rhythms suggestive of atrial fibrillation.
3 Nov

Stimwave

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

Bioelectronic device to treat rheumatoid arthritis

SetPoint Medical, a clinical-stage bioelectronic medicine company developing therapy for chronic autoimmune diseases, has announced the completion of enrollment in the US Food and Drug Administration (FDA) pilot Investigational Device Exemption study evaluating its proprietary bioelectronic device to treat patients with drug refractory rheumatoid arthritis.
25 Oct

VivaLNK and RB launch electronic skin patches for fever monitoring

Earlier this week, VivaLNK formally announced partnership with Reckitt Benckiser (RB) to distribute a wearable continuous temperature monitor worldwide.
22 Oct

Neuromod Devices

Neuromod Devices is a bioelectronic medicine company developing a treatment for tinnitus. IDTechEx analyst Nadia Tsao interviewed Neuromod's CBO Rosemarie Tully on 21 Sep 2018.
18 Oct

SPR Therapeutics

SPR Therapeutics is a bioelectronic medicine company and has developed the SPRINT PNS platform for treatment of acute and chronic pain.
5 Oct

Magnetic cloth to aid healing

Green Grace's owner talks about their magnetic fabric, used to promote healing at a cellular level. They have FDA registration and tens of thousands of users in the USA.
1 Oct

Parasym Health

Parasym Health is a bioelectronic medicine company based in the UK. They have developed a device for the treatment for tinnitus.
24 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.
24 Sep

Synthetic biology making strides in key applications

Synthetic biology is making strides in key applications, armed with the ability to create materials never possible before.
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.
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