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Home » Newsletters » BioWorld MedTech

BioWorld MedTech

May 15, 2020

View Archived Issues
Abbott's ID now system

Abbott pushes back on Langone study of ID Now test; FDA cites possibility of swab, transport media issues

Abbott Laboratories’ ID Now test for the SARS-CoV-2 virus made waves when it was introduced thanks to the rapid turnaround time the molecular test promised. But questions about the test’s performance have surfaced several times in recent weeks. The latest criticism comes from a study conducted at the New York University Langone Medical Center, which claims the diagnostic compared poorly against a competitor. However, the U.S. FDA said that it has questions about the swabs and transport media used in connection with the test. As a result, it will stand pat regarding the ID Now’s place in the emergency use authorization (EUA) program. Read More
neurology-dementia-alzheimers.png

Startup C2n raises $20M to back Alzheimer’s blood test toward FDA approval

C2n Diagnostics LLC has received a $20 million investment in its Alzheimer’s blood test, APTUS-Aβ, from the philanthropy group GHR Foundation. The test measures various types of amyloid beta in the blood and then factors in additional data, such as age, to develop a probability score for amyloid-related pathology in the brain. Read More
Myrian XP-Lung product suite

Intrasense obtains CE mark for its CT scanner protocol designed for COVID-19

PARIS – Intrasense SA, of Montpellier, France, has gained CE marking for its CT scanner reading protocol designed for COVID-19. “This major step forward, coming at the same time as U.S. FDA clearance, will allow a true mass rollout of our Myrian XP-Lung system designed for COVID-19,” Nicolas Reymond, CEO of Intrasense, told BioWorld. Read More

Wave Guard’s algorithm-based solution aims to aid in contact tracing

HONG KONG – Contact tracing is seen as one of the more effective measures to contain the current COVID-19 pandemic. Now, an Israeli company may hold the solution with its app-free tech. Herzliya-based Wave Guard Technologies Inc. has an algorithm-based solution that allows government health care agencies to trace contacts of COVID-19-infected individuals accurately, effectively and in real time. Read More
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Zai Lab and Novocure score the first China approval for glioblastoma in 15 years

HONG KONG –Shanghai-based Zai Lab Ltd. has won an approval for the first innovative treatment for glioblastoma approved by China in more than 15 years, with the National Medical Products Administration’s (NMPA) nod for Optune in combination with temozolomide for use in patients with newly diagnosed glioblastoma (GBM), and also as a monotherapy for the treatment of patients with recurrent GBM. Read More
Toraymyxin (PMX) product image

Health Canada approves PMX treatment for sickest COVID-19 patients

TORONTO – The Toraymyxin (PMX) hemoperfusion cartridge developed by Toronto’s Spectral Medical Inc. and used successfully to treat patients during the avian and swine flu pandemics is being eyed to help COVID-19 patients in Canada. Specifically, an emergency interim order from Health Canada expands its use to include treatment of COVID-19 patients with high levels of endotoxin in their blood and in acute respiratory failure. Read More
Hong-Kong-HKEX.png

Peijia raises $302M on HKEX to advance TAVR product, shares up 70% on debut

BEIJING – Suzhou, China-based Peijia Medical Co. Ltd. became the second prerevenue med-tech company to go public on the Hong Kong Stock Exchange (HKEX) after Venus Medtech (Hangzhou) Inc., pocketing HK$2.3 billion (US$302 million) with an aim to develop and commercialize its transcatheter valve therapeutic medical device called Taurusone. 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 15, 2020

New hires and promotions in the med-tech industry, including: Centogene, Mesa Laboratories, Pathmaker Neurosystems. Read More

Financings for May 15, 2020

Med-tech firms raising money in public or private financings, including: Mdxhealth, Pulse Biosciences, Teladoc Health. Read More

In the clinic for May 15, 2020

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Guardant Health, Integra Lifesciences, Medtronic. Read More

Med-tech gainers and losers for May 11-15, 2020

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

Other news to note for May 15, 2020

Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: A*STAR, Avacta, Beyond Air, BVI, BVT, C3.ai, Croma, Duke-NUS, Genscript, Microbix, Microsoft, Proactive MD, R-Biopharm, Roche, Spoke Health, Unitedhealth Group. Read More

Regulatory actions for May 15, 2020

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

Regulatory front for May 15, 2020

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

BioWorld MedTech’s Neurology Extra for May 15, 2020

Keeping you up to date on recent developments in neurology, including: Study finds tDCS does not affect metabolism; AI successfully used to identify different types of brain injuries; Dynamic stimulation of the visual cortex allows blind and sighted people to 'see' shapes. Read More

BioWorld MedTech Patent Highlights: Week 19

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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