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