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Home » Newsletters » BioWorld MedTech

BioWorld MedTech

May 22, 2020

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Illustration of deployed Clottriever

Inari IPO raises $156M, surges as venous clot removal attracts interest amid COVID-19

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
Regulatory-US-FDA-HQ.png

FDA says 28 serology tests withdrawn or pulled from availability in the U.S.

The U.S. FDA reported that 28 serology tests for antibodies for the SARS-CoV-2 virus either have been withdrawn from the market by the sponsor or delisted by the agency for failure to comply with its notification process for emergency use authorization (EUA).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
Drug capsules, broken chain over world map

Pandemic leaves no room for weak link in the supply chain

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
Orthocell CEO with employees in the lab

Australia’s Orthocell submits 510(k) for Celgro regenerative collagen medical device

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
knee-joint-pain.png

Plan with the golden arm deals Navidea phase II imaging win in RA

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

Holiday notice

BioWorld's offices will be closed in observance of Memorial Day in the U.S. No issue will be published Monday, May 25. Read More

Diagnosing the state of COVID-19 testing

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 MedTech explores the complexities of developing accurate, properly regulated tests to help bring the world back online with confidence.

Read More

Appointments and advancements for May 22, 2020

New hires and promotions in the med-tech industry, including: Centerline Biomedical, Exo Imaging, Integra Lifesciences Holdings, Medx Health, Tactile Systems Technology. Read More

Financings for May 22, 2020

Med-tech firms raising money in public or private financings, including: Authenticx, Ra Medical Systems, Rapid Micro Biosystems, Teleflex. Read More

In the clinic for May 22, 2020

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abbott. Read More

Med-tech gainers and losers for May 18-22, 2020

The top 10 med-tech stock gainers and losers for the week. Read More

Other news to note for May 22, 2020

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 actions for May 22, 2020

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Medtronic. Read More

Regulatory front for May 22, 2020

The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Advamed. Read More

BioWorld MedTech’s Neurology Extra for May 22, 2020

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

BioWorld MedTech Patent Highlights: Week 20

BioWorld MedTech presents Patent Highlights, an excerpt of the most important med-tech patents from this week's Cortellis Patents Gazette. Read More

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