Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Advanced Medtech, DNA Genotekm, Global Instrumentation, Perspectum.
For at least the past decade – under both the Obama and Trump administrations, and perhaps even in previous administrations – the U.S. Department of Health and Human Services has been using the “Bank of BARDA” to routinely cover millions of dollars of unrelated spending at the Office of Assistant Secretary for Preparedness and Response, the U.S. Office of Special Counsel said in letters yesterday to President Joe Biden and Congress.
The SARS-CoV-2 virus has now had ample time to mutate, as reports of the proliferation of multiple variants make clear, and the U.S. FDA’s Tim Stenzel said the agency is now focused on three variants, including one recently reported from Israel. Stenzel said on the latest COVID-19 testing town hall that one of the key concerns regarding existing authorized tests is the potential for loss of sensitivity, a problem the agency hopes to overcome without the use of live virus.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Health Canada updates list of recognized standards; FTC posts draft consent agreement for Flo Health; Two more snared in PGx testing scam.
Health care professionals (HCPs) might prefer a new respirator for each shift, but the ongoing shortage has left clinical sites with a need to employ dry heat for filtering facepiece respirator reuse. The U.S. FDA said on a Jan. 26 town hall that it will stick to an established policy that these devices can be processed with dry heat no more than five times, a practice that is likely to stick for the foreseeable future despite that administrators are required to provide fresh units when possible.
Orthospin Ltd.'s outlook was braced by the U.S. FDA's 510(k) clearance of its next-generation digitally enabled, robotic external fixation system. The Autostrut G2 system allows preprogramming of external fixation devices used for orthopedic issues such as lengthening bones, setting complex fractures and correcting deformities.
Longeviti Neuro Solutions LLC has received the U.S. FDA’s nod for use of its Clearfit cranial implant with postoperative ultrasound imaging. The expanded 510(k) clearance could help in reducing radiation exposure linked to other post-neurosurgical imaging modalities. Research has shown that current methods of post-neurosurgical imaging put patients at risk of radiation exposure, and that an estimated 29,000 future cancers could be linked to CT scan used in the U.S. each year. Comprised of polymethyl-methacrylate (PMMA), Clearfit is a neuro-reconstructive implant that surgeons use to reconstruct a patient’s cranium following brain surgery.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Epigenomics out in Medicare NCD for CRC screening; TGA tweaks registration process for class I goods; Global initiative to take on Alzheimer’s; More on EMA cyberattack.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aktiia, Alleviant, Inspired Spine, Longeviti, Spinal Elements.
Theranica Bioelectronics Ltd. has snagged an expanded clearance from the U.S. FDA for use of its smartphone-controlled Nerivio device to treat migraines in adolescents. The new indication, for acute treatment of episodic or chronic migraine in people 12 years and older, is supported by a study published last month in the journal Headache.
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