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RSS FeedPosted by Michael Wonder on 22 Nov 2017
FDA approves first implanted lens that can be adjusted after cataract surgery to improve vision without eyeglasses in some patients
22 November 2017 - FDA approved the RxSight Inc. Light Adjustable Lens and Light Delivery Device, which can make small adjustments ...
Posted by Michael Wonder on 19 Nov 2017
What if you knew Alzheimer’s was coming for you?
17 November 2017 - Simple blood tests may soon be able to deliver alarming news about your cognitive health. ...
Posted by Michael Wonder on 15 Nov 2017
FDA grants marketing authorisation of the first device for use in helping to reduce the symptoms of opioid withdrawal
15 November 2017 - Today, the U.S. FDA granted a new indication to an electric stimulation device for use in ...
Posted by Michael Wonder on 15 Nov 2017
FDA unveils a streamlined path for the authorisation of tumour profiling tests alongside its latest product action
15 November 2017 - The U.S. FDA today authorised Memorial Sloan Kettering Cancer Center’s IMPACT (Integrated Mutation Profiling of Actionable Cancer ...
Posted by Michael Wonder on 14 Nov 2017
FDA approves pill with sensor that digitally tracks if patients have ingested their medication
13 November 2017 - New tool for patients taking Abilify. ...
Posted by Michael Wonder on 07 Nov 2017
Statement from FDA Commissioner Scott Gottlieb, M.D., on implementation of agency’s streamlined development and review pathway for consumer tests that evaluate genetic health risks
6 November 2017 - At a time when people are more aware of and engaged in their health care than ...
Posted by Michael Wonder on 07 Nov 2017
FDA clears common blood cell count test that offers faster results for patients and providers
6 November 2017 - The U.S. FDA today cleared a complete blood cell count test that, based on its categorisation, ...
Posted by Michael Wonder on 24 Oct 2017
Medical device development tools: helping to speed medical device evaluation and approval
24 October 2017 - The FDA relies on sound science in its decision-making, which provides medical device innovators with a ...
Posted by Michael Wonder on 24 Oct 2017
Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to advance medical device innovation and help patients gain faster access to beneficial technologies
24 October 2017 - Enabling patients and providers to have efficient access to new and innovative medical products that meet ...
Posted by Michael Wonder on 24 Oct 2017
United Therapeutics announces FDA approval of third generation nebuliser for the Tyvaso inhalation system
23 October 2017 - United Therapeutics today announced approval by the U.S. FDA of a new inhalation device, called the ...
Posted by Michael Wonder on 16 Oct 2017
FDA clears new robotically-assisted surgical device for adult patients
13 October 2017 - Today, the U.S. FDA cleared the Senhance System, a new robotically-assisted surgical device (RASD) that can ...
Posted by Michael Wonder on 12 Oct 2017
FDA clears first 7T magnetic resonance imaging device
12 October 2017 - Today, the U.S. FDA cleared the first seven tesla (7T) magnetic resonance imaging device, more than ...
Posted by Michael Wonder on 07 Oct 2017
FDA approves implantable device to treat moderate to severe central sleep apnea
6 October 2017 - The U.S. FDA today approved a new treatment option for patients who have been diagnosed with ...
Posted by Michael Wonder on 28 Sep 2017
FDA approves first continuous glucose monitoring system for adults not requiring blood sample calibration
27 September 2017 - The U.S. FDA today approved the FreeStyle Libre Flash Glucose Monitoring System, the first continuous glucose ...
Posted by Michael Wonder on 26 Sep 2017
How patient preferences contribute to regulatory decisions for medical devices
25 September 2017 - Since we launched our Patient Preference Initiative as part of our medical device regulatory decision-making process ...