Wall Street has stabilized enough after the recent pandemic-induced volatility to offer enthusiastic support to a med tech generating significant revenue that already reached breakeven during the first quarter. Inari Medical Inc. priced its IPO at the top of an already upwardly revised range to raise $156 million. It sold 8.2 million shares at $19, above the prior range of $17 to $18. Shares of the Irvine, Calif.-based company (NASDAQ:NARI) then more than doubled to hit about $43 on its first day of trading. Read More
The U.S. FDA reported that 28 serology tests for antibodies for the SARS-CoV-2 virus either have been withdrawn from the market by the sponsor or delisted by the agency for failure to comply with its notification process for emergency use authorization (EUA). The agency said the list of unavailable tests will be updated over time. For his part, Commissioner Stephen Hahn said the move was undertaken “to ensure that Americans have access to trustworthy tests.” Read More
Scaling up to manufacture a massive volume of a COVID-19 vaccine, drug or innovative device that’s still in early stage development is easier said than done, especially in a global pandemic that has the supply chain stretched beyond capacity. Read More
PERTH, Australia – Perth-based regenerative medicine company Orthocell Ltd. has submitted a 510(k) application to the U.S. FDA for its Celgro collagen medical device for dental guided bone and soft tissue regeneration applications. The submission follows positive results from an FDA-guided bone regeneration study, which is a key component toward the goal of gaining U.S. marketing approval. Read More
Navidea Biopharmaceuticals Inc. CEO Jed Latkin said positive findings from the second interim analysis of the phase IIb study called NAV3-31 “were certainly better than what we were looking for” and will “make our partnering discussions a lot more interesting.” Read More
The challenges to deploy diagnostic and surveillance testing for the COVID-19 pandemic will persist at least until a vaccine is ready if not well beyond that milestone. In our series “Diagnosing the state of COVID-19 testing,” BioWorld MedTechexplores the complexities of developing accurate, properly regulated tests to help bring the world back online with confidence.
New hires and promotions in the med-tech industry, including: Centerline Biomedical, Exo Imaging, Integra Lifesciences Holdings, Medx Health, Tactile Systems Technology. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Avra, Cls Laserthermia Systems, Infinite Mind, Kahala Biosciences, Orasure, Osang Healthcare, Ra Medical, Rymedi, SG Blocks, Tiziana. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Medtronic. Read More
Keeping you up to date on recent developments in neurology, including: Noninvasive brain stimulation controls monkeys' choices; Researchers link gene mutation to autism behaviors; Atherosclerosis, AD meet at the myelin; Early roots of ALS visible in teeth. Read More
