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Innovations

Chest Drainage System

Developed and manufactured in South Africa, the SINAPI CHEST DRAIN range aids recovery by improving drainage efficiency and promoting patient mobility
 
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Innovations

Stereotactic Pointer

A frameless navigation system used in neurosurgery to localise brain tumours and cysts.
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Innovations

Ti-TaMED Spinal System

 The Ti-TaMED spinal system is a comprehensive spinal system that can be easily inserted by surgeons and it is user-friendly to theatre staff. It is locally manufactured to provide an affordable system of the highest quality that is accessible to the South African market and globally. For a more detailed look into our products and company, please visit http://www.titamed.co.za  

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Innovations

Lodox whole body scan

To save the lives of the critically injured, the period following an injury is deemed to be the "golden hour". 13 Seconds, however, can be priceless!

The Lodox Statscan is a digital x-ray scanning system that can produce clear, diagnostic full-body x-ray pictures in just 13 seconds

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Industry News

Europe’s EN ISO 13485:2016 Out Now – But Another Review Expected In Three Years

The EU version of ISO 13485:2016, the long-awaited, revised international quality systems standard has now been published. But manufacturers in the EU need to wait until EN ISO 13485:2016 has been “harmonized” before they can use it.....

Industry News

IMDRF Tackles Confusion Over Clinical Evidence Expectations for Device Software

If all goes to plan, the International Medical Device Regulators Forum will have completed by July a draft guidance that explores when and to what level clinical evaluation and evidence is necessary or acceptable to support marketing authorizations of.....

Industry News

CLINICAL CORNER: BSX And Mayo Collaborate; More Support For Stent-Retrievers; IVD Trial Results

Clinica’s Clinical Corner provides an update on the latest R&D news and developments in ongoing clinical trials of early-, late-stage and approved medical devices.

Boston Scientific,Mayo Clinic Sign.....

Industry News

BUSINESS BITES: Endeavour Eyes More Medtech Plays; M3i Puts Yen In Artificial Heart; Curetis Makes Third mDx Launch

Endeavour Vision’s fund, Endeavour Medtech Growth LP (EMG), is looking to invest in “high potential” European and US medical device and digital health companies that are starting to take their first steps to commercialize.....

Industry News

Commission To Discuss Medtech Standards Future Once Regs Are Adopted

The European Commission will continue discussions on the structure of the harmonized medtech standards once the revised legislation on medical devices and IVDs is adopted, but the Commission services are currently focused on the negotiations on the.....

Industry News

How Are Japan’s New Regenerative Medicine Regulations Playing Out?

Japan formally adopted ground-breaking new and revised legislation governing the regulation of cell and tissue therapies in November 2014 and the feedback on the new framework has been positive.

The global regenerative medicine market, with an.....

Industry News

FDA Appears Ready To Approve Abiomed's Impella Pumps For Cardiogenic Shock By Mid-Year

The US FDA will not ask its Circulatory System Devices Panel to review Abiomed’s PMA supplement for a cardiogenic shock indication for its Impella line of ventricular assist devices, according to the company.

Abiomed and the FDA have.....

Industry News

AdvaMed Tells US FDA Which Guidelines Need To Be Finalized First

US medtech trade group AdvaMed is calling on the Food and Drug Administration to prioritize completing five of the 12 final guidelines that the agency said it intends to complete in fiscal year 2016, including

Industry News

New Study Suggests Mammograms Could Identify Patients At High Risk For Heart Disease

New trial results suggest that breast arterial calcification on digital mammography is a better predictor of coronary artery calcification than standard cardiovascular risk factors.

Coronary artery calcium (CAC) is

Industry News

Senate Bill Would Encourage Adverse-Event Reporting Experimentation

Two senators, one from each party, have introduced a bill that parallels device industry-friendly sections of the 21st Century Cures Act that cleared the House last year, but also adds something new: a provision to give FDA more flexibility to pilot.....