Company Insight – Page 32 – media

Takeda and BioSurfaces to develop new medical devices for GI indications

Japan's Takeda Pharmaceutical Company has signed an agreement with US-based nanotechnology provider BioSurfaces to develop new therapeutic devices to treat gastrointestinal (GI) diseases.
- Source: Medicaldevice-network
- 427
- July 28, 2017
Company Insight gastrointestinal nanofibrous New Approvals
Sensus gets Chinese regulatory approval for keloid device

US-based Sensus Healthcare has received approval from the China Food and Drug Administration (CFDA) to commercialise its keloid prevention and treatment device, SRT-100. The tool is designed to deliver a precise and calibrated dose of superficial radiation therapy to ensure a skin deep and safe treatment for patients. The low-dose radiation is intended to destroy keloid-causing non-malignant tumour cells, basal cell carcinoma and squamous cell carcinoma without the use of anaesthesia, risk of infection, scarring or the need for reconstructive plastic surgery. Sensus intends to introduce SRT-100 into the country’s market in the fourth quarter of this year through its Chinese partner Chindex Medical, which is a division of Fosun Pharma International. The device will focus on prevention and treatment of keloids associated with Cesarean sections (C-sections). Sensus Healthcare CEO Joe Sardano said: “CFDA clearance of the SRT-100 for the treatment and prevention of keloids is an important milestone for ...
- Source: Medicaldevice-network
- 453
- July 28, 2017
CFDA Company Insight keloid New Approvals
Teleflex’s arterial catheterisation device obtains FDA clearance

Teleflex has obtained market clearance from the US Food and Drug Administration (FDA) for its Arrow Seldinger arterial catheterisation device.
- Source: Medicaldevice-network-com
- 456
- July 26, 2017
catheter Company Insight diagnostic FDA New Approvals
OraSure’s HIV self-test gets WHO prequalification

US-based point-of-care (POC) diagnostics developer OraSure Technologies has obtained prequalification from the World Health Organisation (WHO) for its OraQuick HIV Self-Test (HIVST).
- Source: Medicaldevice-network-com
- 516
- July 26, 2017
Company Insight HIV Researches WHO
Samsung launches new mobile full-body CT scanner

Samsung Electronics’ healthcare unit Samsung NeuroLogica has launched a new mobile, portable full-body computed tomography (CT) scanner, BodyTom Elite.
- Source: Medicaldevice-network-com
- 554
- July 26, 2017
Company Insight CT scanner New Approvals
Aspect Imaging’s neonatal MRI device gains FDA clearance

Aspect Imaging has secured 510(k) clearance for the commercialisation of its neonatal brain and head magnetic resonance imaging (MRI) device from the US Food and Drug Administration (FDA).
- Source: Medicaldevice
- 507
- July 24, 2017
Aspect Imaging Company Insight FDA MRI
NovellusDx to use Gene Editing Institute’s technology for cancer diagnostics

Israel-based NovellusDx has established a genomic cancer research partnership with Christiana Care Health System's Gene Editing Institute to speed-up the development of treatments for the disease.
- Source: Medicaldevice
- 471
- July 24, 2017
cancer Company Insight NovellusDx
Tentative US approval for Merck’s diabetes therapy

The US Food and Drug Administration has given a tentative green light to Merck & Co’s follow-on biologic basal insulin Lusduna Nexvue.
- Source: pharmatimes
- 476
- July 21, 2017
Company Insight diabetes Lusduna Nexvue Market Views
Sanofi, Ablynx sign $2.7bn research, licensing pact

Sanofi has signed a research pact and licensing deal with Ablynx that could bring as much as $2.7 billion euros to the Belgian biotech’s coffers if all targets are met.
- Source: pharmatimes
- 506
- July 21, 2017
Company Insight Market Views Sanofi Ablynx
Sanofi snaps up Protein Sciences for $650 million

Sanofi is to buy private US vaccines biotech Protein Sciences in a deal valued at up to $750 million, in a move to bolster its vaccines portfolio.
- Source: pharmatimes
- 461
- July 7, 2017
Company Insight Market Views vaccine

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