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FDA suggests controls on interoperable devices

The final FDA guidance on design consideration and pre-market submission for interoperable medical devices was released on September 6. The demand for these devices is increasing in the healthcare system as our dependence on more rapid and protected interactions between devices grows. This increase presents a need for a parallel increase in adequate FDA regulations for this elaborate device field.
- Source: massdevice
- 568
- December 14, 2017
FDA interoperable medical device Policy
Bayer receives approval in China for Stivarga® (regorafenib) for the second-line systemic Treatment of liver cancer

Approval based on data from the Phase III RESORCE study where Stivarga® (regorafenib) demonstrated significant improvement in overall survival in hepatocellular carcinoma (HCC) patients previously treated with Nexavar® (sorafenib)
- Source: investor.bayer
- 701
- December 14, 2017
Bayer CFDA hepatocellular carcinoma Nexavar® Stivarga®
New research suggests ‘Man Flu’ may be real

Contrary to popular belief, and the opinions of many women, men really do suffer from 'man flu,' at least according to a Canadian researcher and his most recent study.
- Source: msn
- 478
- December 14, 2017
man flu Researches
‘Ground-breaking’ new drug gives hope in Huntington’s disease

A DNA double helix is seen in an undated artist's illustration released by the National Human Genome Research Institute to Reuters on May 15, 2012. REUTERS/National Human Genome Research Institute/Handout.
- Source: in.reuters
- 575
- December 13, 2017
devastating genetic disease Huntington’s Disease Researches
Tiny Wireless Neurostimulator Small Enough for Injections

The team has unveiled a neural stimulator that is less than a cubic millimeter in size that can be placed directly where desired and that is powered using an external induction-based system.
- Source: medgadget
- 545
- December 13, 2017
Neurostimulators Parkinson’s disease
Picture of Health– Can AI Eye Scan Reveal What Ails You?

The light-sensitive layer found at the back of a person's eyes contains more than just cells that detect shadows and light — it also contains information about the health of a person's entire body. And now, artificial intelligence can glean this information from a single snapshot, new research suggests.
- Source: livescience
- 829
- December 13, 2017
Artificial Intelligence Optical coherence tomography Researches
FDA Approves Admelog, the First Short-acting “Follow-on” Insulin Product to Treat Diabetes

The U.S. Food and Drug Administration(FDA) approved Admelog (insulin lispro injection), a short-acting insulin indicated to improve control in blood sugar levels in adults and pediatric patients aged 3 years and older with type 1 diabetes mellitus and adults with type 2 diabetes mellitus. Admelog is the first short-acting insulin approved as a “follow-on” product (submitted through the agency’s 505(b)(2) pathway).
- Source: fda.gov
- 602
- December 13, 2017
Admelog blood sugar diabetes New Approvals
OTC Viagra– Pfizer snags nod for nonprescription sales of the little blue pill for men in the U.K.

Pfizer has won a first approval for OTC Viagra. Viagra Connect, the Pfizer OTC name for its blockbuster erectile dysfunction drug, has been approved for sale in the U.K.
- Source: Fiercepharma
- 558
- December 13, 2017
erectile dysfunction drug New Approvals OTC Viagra Pfizer
Mayo Clinic deal and $5m funding for health data platform Biofourmis

Singapore-based health analytics platform Biofourmis announced the close of its series A funding round, while also unveiling a partnership with US medical research institute, the Mayo Clinic.
- Source: Techinasia
- 528
- December 13, 2017
health analytics platform heart failure Series
Dengue vaccine not deadly–Sanofi, Philippines

A world-first dengue vaccination programme in the Philippines that was suspended over safety concerns will not cause anyone who was immunised to die, drug manufacturer Sanofi and local authorities said on Monday
- Source: msn
- 687
- December 13, 2017
Company Insight dengue vaccination programme Sanofi

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