Sonivie Ltd. has won breakthrough device designation from the U.S. FDA for the Therapeutic Intra-Vascular Ultrasound (TIVUS) system for renal artery denervation to treat resistant hypertension. The company also revealed that it has bought the remaining intellectual property and other assets related to the use of the TIVUS System from Cardiosonic Inc. Sonivie previously licensed technology related to the use of TIVUS in the treatment of pulmonary arterial hypertension.

FDA’s Stenzel says staff surge working as evidenced by 65 serology decisions in two weeks

The latest 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.

Regeltec’s Hydrafil gets breakthrough nod for back pain

A percutaneous hydrogel treatment for chronic low back pain has won U.S. FDA breakthrough device designation. The status will enhance interactions between Regeltec Inc. and the agency during regulatory review of the Hydrafil implant, accelerating the path to clinical trials and commercialization.

Mahana, Freespira ride wave of prescription digital therapeutics

The rising tide of digital therapeutics approved and funded in the U.S. raised the outlook for Mahana Therapeutics 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.

Indian rules pave way for mandatory registration, but patenting concerns remain

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.

Phar-East 2020 virtual conference looks at tech and transformation

HONG KONG – New approaches to trials, digitalization and the effective use of advance technologies like artificial intelligence are reshaping how clinical trials are conducted, drugs discovered or new devices developed, said participants at the Asia-focused Phar-East 2020 conference on Dec. 8.

Canada follows U.K. in approving COVID-19 vaccine

Health Canada jumped on the fast-moving mRNA train today with its authorization of the Pfizer Inc./Biontech SE COVID-19 vaccine. The move came just two days after the U.K. began administering the vaccine, which it conditionally approved last week. As a condition of the Canadian authorization, Pfizer and Biontech must continue to provide Health Canada with information on the vaccine’s safety, efficacy and quality to ensure its benefits are demonstrated in the real world. The agency said the manufacturers plan to follow study participants for two years following their second dose of the two-dose regimen.

Also in the news

BD, Cerule, Cognitivecare, Colospan, Cytosorbents, Day Zero, Delcath Systems, Edap Tms, Ellume, Exact Sciences, Follica, Frazier, Fresenius Kabi, Htg Molecular Diagnostics, Kit Check, Lungpacer Medical, Medical Ingenuities, Menarini Silicon Biosystems, Menicon, Meridian, Mesa, Mojo Vision, Nanostring, Opgen, Penny AI, Protech Home Medical, Regeltec, Sebia, Sengine Precision Medicine, Sight Diagnostics, Skinopathy, Sonivie, Sorento, Vitalhub, Visualdx, Volta Medical