The FDA published a draft rule on Oct. 19 for over-the-counter hearing aids, four years after the Food and Drug Administration Reauthorization Act (FDARA) had directed the agency to do so by 2020. One of the potentially more problematic aspects of the draft is that the rule would be preemptive of state law on several points, including consumer protections, a consideration that could serve as a flashpoint in future litigation. Read More
DUBLIN – Sofinnova Partners closed out its flagship Capital X fund at €472 million (US$550 million), providing further evidence that private equity investing in European biotechnology and medical technology remains in rude health. It represents, managing partner Graziano Seghezzi told BioWorld, one of the most successful fundraising campaigns in its 30-year history. “We went out and raised this fund in six months.” Read More
X-trodes Ltd. has raised $4.5 million to develop its portfolio of wearable smart technologies that measure and analyze electrophysiological signals. Tel Aviv-based X-trodes is developing two products – a wireless system “Smart Skin” for sleep monitoring and a wearable system to prevent muscle injuries and accelerate recovery. The core technology is based on an intellectual property (IP) developed in the nanotechnology laboratory of Tel Aviv University. Read More
Natera Inc. added its Prospera assessment for lung transplant patients to its portfolio, joining the company’s tests for rejection of kidney and heart transplants. The test uses donor-derived cell-free DNA (dd-cfDNA) to detect acute rejection as well as chronic rejection and infection in stable patients. Results of the VALID study presented at CHEST 2021 demonstrated that the Prospera Lung test had a negative predictive value of 97.33%, sensitivity of 89.06% and area under the curve of 0.91. Read More
LONDON – Inivata Ltd. is extending efforts to bring its liquid biopsies into routine use, in two new clinical trials in lung cancer. The first will attempt to show increased speed in getting advanced non-small-cell lung cancer (NSCLC) patients on to the most appropriate therapies. The second study aims to demonstrate that detecting circulating tumor DNA (ctDNA) will single out those early-stage lung cancer patients who have residual or recurring disease after surgery and need further treatment with chemo- or immuno-therapies. Read More
The U.S. Centers for Medicare & Medicaid Services’ (CMS) withdrawal of a proposal to provide automatic coverage of FDA-designated breakthrough devices has drawn criticism from device makers, but the industrial reaction runs the gamut. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aichi Cancer Center, Brainscope, Castle Biosciences, Cernostics, Cook Medical, Corvent, Fujitsu, Molex, Phillips-Medisize, Premier, Yankee Alliance. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: SPR Therapeutics, Venus Concept. Read More
