Establishment Labs Holdings Inc. presented remarkably positive results at three years for its Motiva silicone breast implant at The Aesthetic Meeting 2023 in Miami on April 20. In keeping with the two-year results previously presented, the data demonstrated very low rates of device failure or contracture, which have plagued other implants. The strength of the investigational device exemption study makes an approval from the U.S. FDA ever more likely.
The opioid crisis in the U.S. has not yet been resolved, but FDA commissioner Robert Califf said April 19 the agency could do more to resolve the crisis if Congress granted the agency the authority to require that new opioid analgesics offer superior safety relative to currently approved products. Califf laid the blame for the crisis on manufacturers in stating that drug makers had “let us down” in failing to develop novel oral analgesics that avoid the addictive properties that helped to fuel the opioid crisis.
The success of the President’s Emergency Plan for AIDS Relief (PEPFAR) over the past 20 years is one of the biggest challenges in reaching its goal of eliminating HIV as a global public health threat by 2030, members of the U.S. Senate Foreign Relations Committee were told as they moved toward reauthorizing the program for another five years.
Rapidai Inc. received FDA 510(k) clearance for its Rapid NCCT Stroke technology, the latest tool in its portfolio of non-contrast-based solutions for shock and trauma care. The company claims it is the first and only medical device cleared by the agency to detect suspected intracranial hemorrhage (ICH) and large vessel occlusion (LVO) from value-based CT imaging.
Draeger Inc., of Telford, Pa., reported a recall of several lines of positive airway pressure (PAP) and other ventilation products in connection with problems seen in the adhesive used on breathing circuit components. Draeger said it has no reports of adverse events in connection with separation of the affected components during ventilation processes but has completed its testing of the corrective action and is working to replace the affected devices.
Largely underserved pediatric surgery patients in the U.S. could benefit from a new digital laparoscopic surgery solution said its developer Asensus Surgical Inc. Granted a pediatric indication by the U.S. FDA for the Senhance system in late March, the company plans to enter a market that has been largely ignored because of the difficulty performing digital laparoscopic surgery on smaller body patients.
The U.S. FDA has cleared Aroa Biosurgery Ltd.’s 510(k) for its Enivo pump and catheter, which are key components of the company’s new Enivo tissue apposition platform. The device applies negative pressure to a surgical site, helping to reduce fluid accumulation following surgery. It has been cleared for use in removing surgical and bodily fluids from a closed wound for hematoma and seroma prophylaxis following plastic surgery or other general surgeries where large flaps are formed.
Abbott Laboratories Inc. landed U.S. FDA clearance for its Freestyle Libre 3 integrated continuous glucose monitoring system (CGM)’s reader device a bit earlier than expected. With the regulatory greenlight for the durable medical equipment component received, the company is now pursuing coverage by the CMS for the entire Freestyle Libre 3 system. The system’s sensor received FDA clearance in May 2022.
Motus GI Holdings Inc. undertook further lifesaving measures to survive into 2024 as it continues to seek strategic and financial alternatives that will enable the company to accelerate commercialization of its Pure-Vu endoscopy system. CEO Tim Moran became chairman of the board as former CEO—and current President, Chief Operating Officer and director—Mark Pomeranz added the CEO position to his portfolio.
Phenomix Sciences Inc. has launched a first-of-its-kind test that could provide precision medicine treatment options for patients suffering from a particular form of obesity. Key to the saliva-based Hungry Gut test for patients still hungry after eating is the science of phenotyping enabling specialists to determine genetic sources for this and other distinct obesity conditions.
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