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EU OKs first-line use of AZ’ Faslodex

EU regulators are permitting the use of AstraZeneca’s breast cancer drug Faslodex at an earlier stage of the treatment pathway in patients with certain forms of the disease.

Source: pharmatimes
764
July 28, 2017

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
423
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
450
July 28, 2017

CFDA Company Insight keloid New Approvals

ViiV’s long-acting two-drug HIV regimen hits targets

A long-acting, two-drug HIV regimen being co-developed by ViiV Healthcare and Janssen Sciences Ireland UC has shown comparable viral suppression rates to a three-drug regimen in a Phase II trial, indicating its potential to reduce the dosing burden for patients and thus improve treatment adherence. The LATTE-2 study assessed long-acting, injectable formulations of cabotegravir (ViiV) and rilpivirine (Janssen, branded Edurant), given every four or eight weeks to patients with HIV-1 infection who had already achieved viral suppression with a daily three-drug oral regimen of cabotegravir plus two nucleoside reverse transcriptase inhibitors (NRTIs). Following 96 weeks of maintenance treatment, viral suppression rates for the two-drug regimen dosed every eight weeks (94 percent) or every four weeks (87 percent) were comparable to the rate observed in patients continuing with a three-drug oral regimen (84 percent). In the study, data from which were published in The Lancet and presented at the annual conference ...

Source: Medicaldevice-network
510
July 27, 2017

Clinical Trials formulation HIV Researches

FDA clears BD’s immunological IVD system for commercialization

FDA has granted 510(k) clearance to Becton, Dickinson and Company’s (BD) in-vitro diagnostic (IVD) device, FACSLyric flow cytometer system.

Source: Medicaldevice-network.com
524
July 27, 2017

Clinical FDA immune New Approvals

SLU begins trial for device to treat postpartum haemorrhage

US-based Saint Louis University (SLU) Care has started a clinical trial to evaluate the InPress Postpartum Haemorrhage Intrauterine device as a potential treatment to stop excessive bleeding for mothers after childbirth.

Source: Medicaldevice-network.com
511
July 27, 2017

Clinical Trials hemorrhage

A Medical Market of 1.3 Billion People

When someone mentions India, what comes to your mind first? Rich curry, green trains overloaded with passengers, gorgeous and exotic women with headscarves and jubilant Bollywood movies may be most peoples’ answer. In actual fact, India can also be seen as a medical market of 1.3 billion people. Firstly, India is the world’s second most populous country with a population of 1.3 billion and a giant demand for pharmaceuticals and medical devices. According to a report by credit rating agency CRISIL, the population of India is estimated to reach 1.4 billion by the year 2026 with half the population being over 30 years old, increasing from the present 40% to an estimated 50%. This means that India will have a greater demand for pharmaceuticals and medical devices and more sufficient medical services for the aging population than ever before. The number of deaths in India in 2012 was estimated to be 9.8 million, of which 77% died from illness and health problems.The ...

Source: drugdu
905
July 26, 2017

Ddu News medical device Medicall

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
455
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
511
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
551
July 26, 2017

Company Insight CT scanner New Approvals

EU OKs first-line use of AZ’ Faslodex

Takeda and BioSurfaces to develop new medical devices for GI indications

Sensus gets Chinese regulatory approval for keloid device

ViiV’s long-acting two-drug HIV regimen hits targets

FDA clears BD’s immunological IVD system for commercialization

SLU begins trial for device to treat postpartum haemorrhage

A Medical Market of 1.3 Billion People

Teleflex’s arterial catheterisation device obtains FDA clearance

OraSure’s HIV self-test gets WHO prequalification

Samsung launches new mobile full-body CT scanner

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