Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Mahana Therapeutics, Nanovibronix, Paige.AI, Solvd Health, Zebra Medical Vision.
Airehealth Inc.'s management took a deep breath on hearing that the company's Vitalmed nebulizer received U.S. FDA 510(k) clearance after waiting nearly 11 months. The portable, electronic, vibrating mesh nebulizer will connect to the Orlando, Fla.-based company's diary companion app early next year as part of an integrated suite of products designed to help individuals with chronic respiratory issues track symptoms and better manage their care.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA issues guidance on enforcement policy regarding certain quality standards requirements under MQSA; MHRA looks to provide additional help post-Brexit.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Advaite, Airehealth, Rheonix.
It’s official. After a weekend of rumors and speculation, President-elect Joe Biden formally announced the nomination of California Attorney General Xavier Becerra Dec. 7 as secretary of the U.S. Department of Health and Human Services, along with Vivek Murthy as surgeon general.
PERTH, Australia – Australia's Therapeutic Goods Administration (TGA) is requiring manufacturers of permanently implantable devices to provide patient implant cards and consumer device leaflets with their devices, beginning Dec. 1. New implantable devices will need to comply by Dec. 1, 2020, and existing implantable devices will have until Dec. 1, 2021, to comply.
For the 795,000 Americans who suffer a stroke each year, time is brain. The U.S. FDA granted 510(k) clearance to a solution the developer says could cut time-to-treatment in stroke by an hour, preserving 3.6 years of healthy life. Nico.lab’s artificial intelligence-based CT scan analyzer, Strokeviewer LVO, uses an algorithm that enables faster triaging of stroke patients and enables physicians to see the location of occlusions in minutes.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: New notified body for IVDs brings total to five; U.S. securities compliance not optional for foreign companies; USPTO touts early results of amendment pilot.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Caretaker Medical, Viveve.
PERTH, Australia – Australia’s Therapeutic Good Administration (TGA) has unveiled its final regulatory requirements for personalized medical devices, including 3D-printed devices, that go into effect on Feb. 25, 2021. Under the previous framework, custom-made medical devices were exempt from the requirement to be included in the Australian Register of Therapeutic Goods (ARTG).
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