The latest U.S. FDA town hall for diagnostics included the usual technical questions about test validation, but there are some frustrations among test developers regarding turn-around times for emergency use authorizations (EUAs). Nonetheless, Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health (OIR) at the FDA, said the surge in staff assigned to review EUA filings has worked to some benefit, claiming that the agency has rendered a decision in connection with 65 applications in the two weeks leading up to the Dec. 9 town hall.
The rising tide of digital therapeutics approved and funded in the U.S. raised the outlook for Mahana Therapeutics Inc. and Freespira Inc. as both companies announced good news. Mahana's prescription digital therapeutic for gastrointestinal conditions, Parallel, received premarket authorization from the U.S. FDA and Freespira, formerly Palo Alto Health Sciences Inc., raised $10 million for its digital therapeutic for panic attacks, panic disorder and post-traumatic stress disorder.
Sonivie Ltd. has won breakthrough device designation from the U.S. FDA for the Therapeutic Intra-Vascular Ultrasound (TIVUS) system for renal artery denervation (RDN) to treat resistant hypertension. At the same time, the company revealed that it has bought the remaining intellectual property and other assets related to the use of the TIVUS System from Cardiosonic Inc.
A percutaneous hydrogel treatment for chronic low back pain has won a U.S. FDA breakthrough device designation. The status will enhance interactions between Baltimore, Md.-based Regeltec Inc. and the agency during regulatory review of the Hydrafil implant, accelerating the path to clinical trials and commercialization.
Calling it a “a critical milestone in its fight against COVID-19,” Health Canada authorized the Pfizer Inc./Biontech SE COVID-19 vaccine for people age 16 or older.
NEW DELHI – Recent changes to India’s rules on medical devices have evoked mixed reaction among industry and legal experts with concerns over their impact on patenting of innovations tinged with a welcome reception of a new clause for mandatory registration and licensing of medical devices in the country to improve adherence to quality requirements.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: USPTO finalizes SAS rule, U.S. senators press case for permanent telehealth, CMS no fan of national coverage policy for Allomap, TGA posts guidance for class I tests, Marburg MCMs protected under PREP.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Medical Ingenuities, Mesa Biotech, Regeltec, Sonivie, Volta Medical.
Paige has received good news in the EU, securing a CE mark for its breast cancer detection software that highlights suspicious areas for pathologists to review further. It also received a CE mark for Paige Prostate Grading & Quantification, which offers slide level information for primary and secondary Gleason patterns and tumor size to inform treatment planning.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA: Metal-containing masks can cause injuries during MRIs.
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