Edwards Lifesciences Corp. reported good news this week, with its third-quarter results exceeding expectations. Sales came in at $1.1 billion, an increase of 4%, and CEO Mike Mussallem highlighted the success of transcatheter aortic valve replacement (TAVR), with the Sapien valve platform performing well. Mussallem noted that TAVR sales were $745 million, up 6%, with Europe showing strength. Read More
Neuromod Devices Ltd., which is developing an at-home, self-managed treatment for tinnitus, closed a €10.5 million (US$12.4 million) series B financing led by majority investor Fountain Healthcare Partners. The funds are earmarked for expanding European commercialization of the Lenire tinnitus treatment device, to scale up manufacturing, progress U.S. FDA regulatory approval and pursue opportunities with the U.S. Department of Veterans Affairs (VA). Read More
Patient engagement is increasingly the order of the day in the device development process as the U.S. FDA has made clear, a consideration that drove the Oct. 22 FDA advisory hearing. A patient representative said patients want to take part as early as possible in the development process for software as a medical device (SaMD), and Pat Baird, director of global software standards for Royal Pillips NV, said industry is very much open to ideas about bringing the patient perspective on board earlier in that process. Read More
Researchers at Israel’s Ben-Gurion University have launched a machine learning platform that aims to streamline the clinical trial process using predictive analytics. The technology has been licensed to Panacea, a startup company formed by BGN Technology. Read More
With the lack of public trust and confidence the biggest barrier to SARS-CoV-2 vaccines in the U.S., the risk of granting an emergency use authorization to a vaccine with safety issues or questionable efficacy could destroy confidence in future FDA-approved products. That message was drummed home throughout the Oct. 22 meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee. Read More
New hires and promotions in the med-tech industry, including: Becton Dickinson, Center for Prove Development and Commercialization, Cricket Health, Soliton, Trisalus. Read More
Med-tech firms raising money in public or private financings, including: Cricket Health, Enviral Tech, Helius Medical Technologies, Invivo Therapeutics Holdings, Neodynamics. Read More
Keeping you up to date on recent developments in diagnostics, including: Study underscores long-term impact of COVID-19; CT scan enhancement via deep learning; Caution in screening for large fetus size. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Adial Pharmaceuticals, Aerogen, CSA Medical, Fabric Genomics, GE Healthcare, Invitae, Joimax, Kamada, Kedrion Biopharma, Leica Microsystems, Ntt Data Services, Oxford Immunotec Global, Pacbio, Teladoc Health, Teva Respiratory, Transmedic, Vidence. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Docbot, Sensus Healthcare, Sequana Medical. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aidoc, Anika, Avioq, Cala Health, Embody. Read More
