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Home » Newsletters » BioWorld MedTech

BioWorld MedTech

Aug. 14, 2020

View Archived Issues
Illustration of human papillomavirus (HPV) infection

Is the HPV test adequate for cervical cancer screening?

In a controversial move, the American Cancer Society (ACS) recently recommended that people with a cervix should have a primary human papillomavirus (HPV) test every five years starting from age 25 to 65 to screen for cervical cancer. The recommendations displace the Papanicolaou (Pap) test that has formed the backbone of cancer screening for decades and extend the time between tests by two years. Read More
Gavel-and-scales.png

Life science companies still the main targets of whistleblower litigation in 2020

Qui tam litigation holds a dear place in the hearts of U.S. federal prosecutors and whistleblowers alike, but the volume of these cases ebbed as the COVID-19 pandemic swept across the nation. A report by Gibson, Dunn & Crutcher LLP makes clear, however, that despite the pandemic-induced drag, these cases are resuming their historical pace, and makers of drugs and devices are once again the most frequently targeted type of business. Read More
Hospital patient, device image

Masimo gets FDA nod for fluid responsiveness indicator

The U.S. FDA has granted 510(k) clearance to Masimo Corp. for its PVi software tool as a continuous, noninvasive, real-time indicator of fluid responsiveness in select populations of mechanically ventilated adults. PVi, which is an acronym for pleth variability index, quantifies the dynamic changes in perfusion index that occur in a patient during the respiratory cycle. Read More
OncoDNA CEO, Integragen CEO

Integragen subject to takeover by OncoDNA for $16.7M

PARIS – Integragen SA and OncoDNA SA have signed a tender offer agreement anticipating a takeover bid. Gosselies, Belgium-based OncoDNA will purchase 100% of the shares of Integragen, floated on the Euronext Paris Euronext Growth Markets, at a unit price of $2.60, valuing the latter’s share capital at $17.2 million. Read More
Sampinute system and Diatrust packaging

Testing, testing as Celltrion aims to launch two COVID-19 kits in the U.S.

HONG KONG – Incheon, South Korea-based Celltrion Inc. is planning to launch two of its three rapid test kits in the U.S. as it plays its part in the global fight against the COVID-19 pandemic. Celltrion said Aug. 12 that its Sampinute COVID-19 Antigen MIA and Diatrust COVID-19 IgG/IgM rapid test kits will launch in the U.S. by the third week of August. Read More

TSX gives thumbs up on documentation supporting agreement on rapid saliva, COVID-19 test

TORONTO – The Toronto Stock Exchange (TSX) has accepted documentation supporting a binding letter of intent between Toronto-based Therma Bright Inc. and arm's-length vendor Orpheus Medica Inc. for development of a rapid saliva, COVID-19 test. Read More

Appointments and advancements for Aug. 14, 2020

New hires and promotions in the med-tech industry, including: Assure Holdings, Conformis, Myriad Genetics, Nephros, NMS Labs. Read More

Financings for Aug. 14, 2020

Med-tech firms raising money in public or private financings, including: Mission Bio, Thirty Madison. Read More

In the clinic for Aug. 14, 2020

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

Med-tech gainers and losers for Aug. 10-14, 2020

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

Other news to note for Aug. 14, 2020

Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biolog, Biospyder, Capsa Healthcare, Connecticut Biotech, Formsense, Htg Molecular Diagnostics, Newrobo, Newsight Imaging, Protokinetix, Sheba Medical Center, Todos Medical, Virusight Diagnostics, Virushield, Xphyto Therapeutics. Read More

Regulatory actions for Aug. 14, 2020

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

Regulatory front for Aug. 14, 2020

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

BioWorld MedTech’s Neurology Extra for Aug. 14, 2020

Keeping you up to date on recent developments in neurology, including: Combining genetic information with EMRs to pinpoint childhood epilepsies; AI-enhanced precision medicine identifies novel autism subtype; From variants to treatments in neurology. Read More

BioWorld MedTech Patent Highlights: Week 32

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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