21st Century Innovative Technologies and Developments as also discoveries, curiosity ( insolite)...

This seizure-spotting smart watch has won FDA approval
Startup Empatica says its Embrace smart watch is now approved by the US Food and Drug Administration as a medical device—a rare designation for a wearable.

Winning approval: The $249 watch detects when a wearer is having a convulsive seizure and lets family members know via a smartphone app. In a 135-patient trial as part of the FDA approval, epilepsy patients suffered 40 seizures, and the watch’s algorithm spotted them all.

Why it matters: There are 3.4 million people in the US with epilepsy. Worldwide, the figure is roughly 50 million. Keeping track of when seizures happen can help get patients medical attention and aid doctors in monitoring their condition over time. 

What it means for wearables: The approval allows the firm to make medical claims about the device, and could enable people with epilepsy to have insurance pay for it. It may also encourage doctors and hospitals to use such devices, says Rosalind Picard, Empatica’s cofounder and chief scientist.

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https://www.scoop.it/t/21st-century-innovative-technologies-and-developments/?&tag=wearables

U.S. regulators have approved the first continuous blood sugar monitor for diabetics that doesn’t need backup finger prick tests.

Current models require users to test a drop of blood twice daily to calibrate, or adjust, the monitor.

The pain of finger sticks and the cost of testing supplies discourage many people from keeping close tabs on their blood sugar, which is needed to manage insulin use and adjust what they eat.

Abbott’s new FreeStyle Libre Flash Glucose Monitoring System, approved Wednesday by the Food and Drug Administration, uses a small sensor attached to the upper arm. Patients wave a reader device over it to see the current blood sugar level and changes over the past eight hours.

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http://www.scoop.it/t/21st-century-innovative-technologies-and-developments/?&tag=Diabetes

The Food and Drug Administration on Wednesday approved the first-ever treatment that genetically alters a patient’s own cells to fight cancer, a milestone that is expected to transform treatment in the coming years.

The new therapy turns a patient’s cells into a “living drug,” and trains them to recognize and attack the disease. It is part of the rapidly growing field of immunotherapy that bolsters the immune system through drugs and other therapies and has, in some cases, led to long remissions and possibly even cures.

The therapy, marketed as Kymriah and made by Novartis, was approved for children and young adults for an aggressive type of leukemia — B-cell acute lymphoblastic leukemia — that has resisted standard treatment or relapsed. The F.D.A. called the disease “devastating and deadly” and said the new treatment fills an “unmet need.”

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http://www.scoop.it/t/21st-century-innovative-technologies-and-developments/?&tag=Blood

http://www.scoop.it/t/21st-century-innovative-technologies-and-developments/?&tag=Cancer

Further proof the U.S. Food and Drug Administration has been warming up to modern technology — it has just approved the first continuous blood sugar monitor that doesn’t require the user to prick themselves over and over for a blood sample.

Today, the FDA cleared Abbot’s FreeStyle Libre Flash Glucose Monitoring System, a device that uses a small sensor wire inserted under the skin to determine glucose levels in adult diabetics. Another wand-like device is then waved over the sensor to measure and give a readout of those glucose levels.

This is a milestone move for the FDA as diabetes affects nearly 30 million people in the United States who currently have to test their blood sugar by pricking themselves several times throughout the day and every time they eat.

Learn more / En savoir plus / Mehr erfahren:

http://www.scoop.it/t/21st-century-innovative-technologies-and-developments/?&tag=Diabetes