The U.S. Department of Health and Human Services (HHS) has withdrawn its August 2020 rescission of the FDA’s authority to regulate lab-developed tests (LDTs), a reversal predicated on the need for additional testing capacity for the COVID-19 pandemic. However, the non-COVID implications are not clear as the FDA is not widely seen as having the capacity to regulate LDTs for non-pandemic purposes, while pending legislation would dramatically overhaul the agency’s approach to LDT regulation, making the current regulatory environment an unstable environment at best. The FDA accompanied the announcement with a statement that the emphasis at the agency is on tests that do not require that the patient sample be sent to a lab for processing. Read More
Patients and investors in Alung Technologies Inc. can breathe a little easier now that the company’s Hemolung respiratory assist system has won a de novo approval from the FDA. The FDA approval comes more than eight years after Hemolung received CE mark and Health Canada approval. Hemolung gained FDA emergency use authorization for patients with COVID-19 in April 2020. Read More
A successful fundraising round by a Chinese surgical robot developer last week underscored the potentially fast growth of a sector that remains underdeveloped in China. Chinese surgical robot company Edge Medical Robotics Co. Ltd. raised $200 million in a series C round, and plans to use the funds for the commercialization of its core products. Read More
My Life Technologies Corp. has raised $4 million from investors to fund production and clinical trials for its microneedle technology. Based in Leiden, Netherlands, the company is developing a ceramic patch that can deliver vaccines or drugs through the skin. The technology could prove to be an attractive alternative to standard vaccine injections due to what the company says is its simple and painless delivery. Read More
The U.S. Centers for Medicare & Medicaid Services (CMS) finally laid to rest the rule for Medicare Coverage of Innovative Technology (MCIT), a policy proposal that found favor with industry and with several patient groups. However, the news comes shortly after a bipartisan group of 10 senators had penned a letter to the agency to reissue the rule, reinforcing the prospect that the MCIT proposal will find widespread support in the halls of Congress in 2022. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Intervenn, Istar, Ivantis, Life Science Biosensor Diagnostics, Masimo. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abdul Latif Jameel, Biognosys, Brain Scientific, Butterfly Network, Cellenion, The Cooper Companies, Diaspective, Nanomix, Omnivision, Orgenesis, Pharmafluidics, Piezo Motion, Precise Motion, Thermo Fisher. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alung Technologies, Medtronic. Read More
