The ongoing pandemic brought about several challenges for investors looking for the next big thing, but some areas still have experienced growth. Experts addressed this topic and other issues during a panel discussion Tuesday at the Cleveland Clinic’s 2020 Medical Innovation Summit. Moderator Lydia Ramsey Pflanzer, health care editor, Business Insider, highlighted a bright spot, noting that by the end of the third quarter, digital health startups were doing well, raising $9.4 billion, according to Rock Health. Read More
The COVID-19 pandemic has been a bump in the road for developers of digital surgical systems that include robotics, but the technology is still in demand. That was the message from industry leaders at the Advanced Medical Technology Association’s Virtual Medtech Conference. Read More
U.S. FDA commissioners must rely on legal counsel for advice on a number of matters, but attorneys who sign on for work at the agency bring with them different views on the limitations of the agency’s powers. This consideration came up during a panel discussion hosted by the Food and Drug Law Institute (FDLI). Read More
Lumos Diagnostics Holdings Pty. Ltd. scooped up AU$25 million (US$17.9 million) in an oversubscribed pre-IPO ahead of its anticipated 2021 listing on the Australian Securities Exchange (ASX). The funds will be used to expand manufacturing operations in California and Florida and to grow the commercial footprint of Febridx, a rapid point-of-care (POC) test that can determine if a person has a viral or bacterial infection within 10 minutes. Read More
The U.S. FDA will no longer review lab-developed tests (LDTs) for the SARS-CoV-2 virus under the emergency use authorization (EUA) program, a change that will eliminate any prospect of immunity from liability for these tests. The FDA’s Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health, announced the news on the weekly COVID-19 testing town hall, but the change was simultaneously unveiled in the FDA’s Q&A for testing. Read More
Biosense Webster Inc. reported U.S. FDA approval of its Thermocool Smarttouch SF ablation catheter for the treatment of patients with persistent atrial fibrillation (persistent AF). This follows results of the prospective, multicenter Precept study, which showed the catheter to be safe and effective for 80% of patients over 15 months of ablation therapy with clinically meaningful improvement in quality of life. Read More
With COVID-19 cases once again surging across the globe and several countries considering targeted lockdowns, vaccines remain the best hope of restoring a sense of normalcy amidst the pandemic. For vaccines to work though, people must have enough confidence in the efficacy and safety that they’re willing to get vaccinated when the vaccines become available. That’s why the emergency use authorization (EUA) guidance the FDA released Oct. 6 for COVID-19 vaccines is so important. Read More
Surprising no one, Jennifer Doudna and Emmanuelle Charpentier won the 2020 Nobel Prize in Chemistry “for the development of a method for genome editing,” that is, the CRISPR/Cas9 system. Read More
Butterfly Medical Ltd. could be on the verge of metamorphosis into a major player in the benign prostatic hyperplasia treatment field. The Yokneam, Israel-based company just raised $7 million in a series B financing led by New Rhein Healthcare Investors LLC, of Philadelphia. Read More
Med-tech firms raising money in public or private financings, including: Avail Medsystems, Cerebral, Hancock Jaffe Laboratories, Nanostring Technologies. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Hologic. Read More
Keeping you up to date on recent developments in orthopedics, including: LED-based UV irradiation safely prevents the loss of bone and muscle mass in mice; Coupling antibiotics with stem cells to fight off bone infections; Study: Unnecessary stress testing performed prior to knee and hip replacement surgeries. Read More
