The U.S. FDA has granted de novo clearance for Epiminder Pty. Ltd.’s Minder implantable device for continuously monitoring brain activity in patients with epilepsy.
The U.S. FDA’s authority to require cybersecurity measures in premarket submissions is a radical change for industry, but firms must document that they have erected solid cybersecurity measures.
In all practicality, U.S. FDA Commissioner Marty Makary’s recently announced policy directive removing industry representatives from the agency’s advisory committees may have little effect on the makeup of the drugs and devices committees, which typically include them as nonvoting members.
The use of Renalytix plc’s Kidneyintelx biomarker-based prognostic test led to increased and targeted use of sodium-glucose cotransporter 2 (SGLT2) inhibitors in patients at risk of diabetic kidney disease, compared to untested patients, according to data from a study.
Staffing cuts at the FDA’s device center led to speculation that the current user fee program may be fatally damaged, but Mark Leahey, president and CEO of the Medical Device Manufacturers Association, said in a meeting in Columbus, Ohio that there are too many resources for FDA at stake for the user fee program to be ended.
The Advanced Medical Technology Association released a policy proposal for AI in medical devices that took the U.S, FDA to task for its guidance for predetermined change control protocols for AI, stating that the guidance is “inconsistent with the statutory authority” for PCCPs.
A U.S. FDA CDER official is among the first to say the quiet part out loud in proposing a Sept. 12 deadline for the agency to respond to Vanda Pharmaceuticals Inc.’s request for summary judgment or a hearing on CDER’s refusal to approve tradipitant to treat gastroparesis.
Europe was a bigger counterpart to China in pharmaceutical dealmaking than the U.S. last year, speakers at Chinabio Partnering Forum said April 23, and the trend is likely to continue in 2025 with the shuttering of U.S. capital and volatility ailing global markets.
Aclaris Therapeutics Inc. has gained IND clearance from the FDA for ATI-052, a bispecific anti-thymic stromal lymphopoietin (TSLP)/interleukin-4 receptor (IL-4R) monoclonal antibody being developed to treat certain immuno-inflammatory diseases. A phase Ia/Ib trial, including a proof-of-concept portion in an undisclosed indication, will begin in the current quarter.
Neuronos Ltd., a subsidiary of Beyond Air Inc., has announced BA-102 has been awarded U.S. orphan drug designation for the treatment of Phelan-McDermid syndrome.
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