Clinical updates, including trial initiations, enrollment status and data readouts and publications: Adaptive Biotechnologies, Hologic, NMDP, Precisedx.
Nua Surgical Ltd. secured €6.5 million ($6.9 million) in series A financing to support regulatory clearance in the U.S. and early commercialization of its Stericision C-section retractor. The device is a self-retaining surgical retractor designed to improve outcomes for mothers undergoing a caesarean section.
Medicare coverage of FDA-designated breakthrough devices is still a policy hot topic. Although the House of Representatives generated some momentum on related legislation, the Senate is now examining the Ensuring Patient Access to Critical Breakthrough Products Act for potential passage in the lame duck session – a development that would draw enthusiastic cheers from industry.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Angiodynamics, Artivion, Copan Diagnostics, Conavi.
Although it does not generally infect humans, a single mutation of the H5N1 virus in the highly pathogenic avian and bovine clade 2.3.4.4b could overcome this barrier and possibly trigger a pandemic. Scientists at The Scripps Research Institute have warned of this possibility after studying the three-dimensional structure of the viral hemagglutinin and seeing how a change in one amino acid would make it more suitable for the human cell receptor. The researchers stress the need to monitor new mutations of this virus in order to act quickly in case the global jump to our species occurs.
Bring your dog to work day looks a little different at Spotitearly. The Tel Aviv-based company asks its canine workers to bring their whole selves to the job – particularly their finely trained noses – to help suss out cancer in breath samples. The dogs’ unique capabilities are interpreted by AI to capture canine indicators humans might miss and the combo has remarkably high accuracy, 93% or better in three of the four common cancers tested.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Coapt, Foresight Diagnostics, Genedx, Hinge Health, Lifewallet, MSP Recovery, Myant, Simx, Zynex.
New research confirmed long-term efficacy and safety of a novel minimally invasive procedure with Insightec Inc.’s Exablate transcanial magnetic resonance-guided focused ultrasound system to alleviate symptoms of severe obsessive-compulsive disorder.