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The FDA attempted to provide clarity on an HHS announcement over the summer that it would no longer require premarket reviews of laboratory-developed tests (LDTs), including LDTs for COVID-19, but the attempt just muddied the water further, according to attorneys at Ropes & Gray. Read More
Medical Device Single Audit Program (MDSAP) activities have continued during the COVID-19 pandemic, forcing auditors and device manufacturers to adapt to a virtual environment. Read More
The FDA’s Office of Regulatory Affairs (ORA) has determined that general and prioritized inspections will remain preannounced for the foreseeable future in order to ensure the safety of those involved during the pandemic, according to a regulatory official. Read More
The catheter uses an innovative force sensor in an isolated tip that provides contact- force measurements in real-time during ablation procedures. Read More
The minimally invasive device uses high-frequency, nonfocused ultrasound to ablate nerves in the renal artery, causing a reduction in nerve activity and decreasing blood pressure. Read More
The PH Band is used alongside a micro Doppler Probe to achieve patient hemostasis following a minimally invasive cardiac or vascular procedure. Read More
The new guidance offers numerous examples to help manufacturers understand how their IVDs should be classified for compliance with the regulation. Read More
“Healthcare providers can use this personalized risk information to make more informed decisions about the use of oral opioids for acute pain when developing pain management plans for their patients,” SOLVD said. Read More