Menlo Park, Calif.-based startup Tusker Medical Inc. has received U.S. FDA approval to market its breakthrough-designated system for inserting tympanostomy tubes into the eardrum to treat recurrent ear infections. The Tubes Under Local Anesthesia (Tula) system is the first delivery system for tympanostomy tubes, commonly known as ear tubes, that can be performed in young children under local anesthesia in a doctor’s office. The Tula system consists of the ionic anesthetic Tymbion, Tusker Medical tympanostomy tubes and several devices for inserting the anesthetic and tubes into the ear drum. A low-level electrical charge delivers the anesthesia to the eardrum prior to tube placement, allowing for quick and needle-free numbing of the tympanic membrane. Read More
One necessary step to fend off a dystopian future of medical care without antibiotics is the development of new antibiotics. Another is improved deployment of existing ones, a feat which will take, among other things, better antibiotic susceptibility testing (AST). “I’m astounded that we can get men to the moon, and we are using practices [dating] almost back to the age of Robert Koch to identify bacteria,” Deborah Hung told BioWorld MedTech. “The standard practice takes amazingly long.” Read More
The U.S. FDA has engaged in an overhaul of its software policies in the wake of the mandates spelled out by the 21st Century Cures Act. However, those policies are still a work in progress, as a recent FDA webinar made clear. The FDA won’t have long to put those policies into place as the U.S. House of Representatives is considering a follow-on to the Cures Act, dubbed Cures 2.0, which will impose yet more changes on the agency’s approach to software regulation. Read More
MELBOURNE, Australia – Researchers at the Murdoch Children’s Research Institute in Melbourne are pushing the boundaries on creating kidney tissue from stem cells. For more than two decades, Melissa Little and her team at Murdoch have investigated the molecular and cell development basis of kidney disease and the potential for regeneration. The team has developed approaches for directing the differentiation of human pluripotent stem cells to human kidney organoids and is applying that knowledge to disease modeling, drug screening, cell therapy and tissue engineering. Read More
PARIS – Dentressangle Initiative SAS, of Lyon, France, is in talks to buy a majority stake in Marle International Holding SAS, an orthopedic implant contract manufacturer. The acquisition is said to be worth $880 million, although Dentressangle has not confirmed this amount. “We are looking forward to supporting the management team in achieving its long-term goal for Marle, of offering higher value-added services to its clients and pursuing target acquisitions,” Thierry Coloigner, managing partner for mid and large cap at Dentressangle, told BioWorld MedTech. Read More
