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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
- 461
- 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
- 521
- 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
- 534
- 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
- 522
- 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
- 952
- 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
- 461
- 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
- 522
- 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
- 561
- July 26, 2017
Company Insight CT scanner New Approvals
Five Tips to Create Better Quotes

Offering a quotation to a client is not always as simple as it sounds and may take some time to master. How can we swiftly attract clients and ensure effective communication with potential customers in a short amount of time?
- Source: Ddu
- 864
- July 25, 2017
Ddu College quotation
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
- 513
- July 24, 2017
Aspect Imaging Company Insight FDA MRI

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