The FDA has approved Medtronic plc’s Evolut FX TAVR system for patients with symptomatic severe aortic stenosis. During Medtronic’s fiscal first quarter earnings call CEO Geoffrey Martha said the company will roll the latest generation system out in the U.S. market later this year, with a full launch planned in 2022.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbott Laboratories, Alpha Healthcare, Anatomage, Baylis, Bioaesthetics, Biosyent, Boston Scientific, Elekta, Healthcare Services Group, Helius Medical Technologies, Humacyte, ID Genomics, Iotron Medical Meadowlands Diagnostics, Osteoid, Photocure, Provista Diagnostics.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aatru Medical, Cellmax Life.
Johnson & Johnson has announced new data supporting use of its COVID-19 vaccine as a booster shot, after separate trial data from the U.K. showed effects of several vaccines waned after six months.
The U.S. Federal Trade Commission (FTC) is hardly alone in its antipathy toward Illumina Inc.'s acquisition of Grail Inc., and FTC attorney Susan Musser said Aug. 24 that Illumina’s dominance of the market for next-generation sequencing (NGS) is perhaps the key aspect of the FTC’s case. Musser invoked the wide number of companies that jumped into the fray to develop a vaccine for the COVID-19 pandemic as an illustration of the need to maintain competition in the multicancer testing space.
TORONTO – Fluid Biotech Inc. has raised $4.7 million in oversubscribed seed funding to further develop and commercialize the world's first hybrid polymer-metal flow-diverting brain stent for curing brain aneurysms that can lead to stroke. Following successful preclinical studies of the stent, attention now turns to applying this fresh capital to hiring contract manufacturers to prepare for first-in-human implantation and production of the mostly polymer-constructed stent.
PARIS – The High Authority for Health (HAS) in France recently published a 165-page report on use over 10 years of long term mechanical circulatory assist devices (MCS). HAS conducted this wide-ranging study to review the conditions for the management of MCS devices, technology that has been constantly evolving over the past decade.
Lightpoint Medical Ltd. is stepping up commercialization activities and collaborating with Telix Pharmaceuticals Ltd. on radio-guided cancer surgery. The companies plan to initiate prostate cancer clinical trials evaluating Lightpoint’s Sensei with Telix’s investigational prostate cancer single photon emission computed tomography (SPECT) imaging agent TLX599-CDx.
For most people, neither polyglutamine disorders nor neuromuscular disorders are likely to be among the things they associate with androgen receptor (AR) dysfunction. But the three are indeed linked. And researchers have reported new insights into the nature of those links that could lead to a treatment for spinal and bulbar muscular atrophy, and possibly other disorders linked to AR signaling dysfunction.