Front Line Medical Technologies Inc. recently received CE mark for its Cobra-OS, the smallest REBOA (resuscitative endovascular balloon occlusion of the aorta) device for use in emergency situations on the market. The company believes that Cobra-OS could help save the lives of patients during traumatic bleeding situations as it could buy valuable time until definitive care can be provided.
In March, the U.S. FDA reported a major shortage of Rhogam, the anti-D immune globulin most widely used to prevent Rh factor incompatibility in pregnancy. Without treatment, second and subsequent pregnancies can be endangered by antibodies created by the mother. With the shortage, the standard treatment of two shots for all pregnant females with Rh-negative blood can be challenging, but Billiontoone Inc.’s Unity prenatal test can eliminate the need for the immune globulin treatment in 40% of these pregnancies.
Front Line Medical Technologies Inc. recently received CE mark for its Cobra-OS, the smallest REBOA (resuscitative endovascular balloon occlusion of the aorta) device for use in emergency situations on the market. The company believes that Cobra-OS could help save the lives of patients during traumatic bleeding situations as it could buy valuable time until definitive care can be provided.
In March, the U.S. FDA reported a major shortage of Rhogam, the anti-D immune globulin most widely used to prevent Rh factor incompatibility in pregnancy. Without treatment, second and subsequent pregnancies can be endangered by antibodies created by the mother. With the shortage, the standard treatment of two shots for all pregnant females with Rh-negative blood can be challenging, but Billiontoone Inc.’s Unity prenatal test can eliminate the need for the immune globulin treatment in 40% of these pregnancies.
Acrivon Therapeutics Inc.’s $130 million financing disclosed April 9 hiked confidence in then-pending data with ACR-368 (prexasertib), the selective small-molecule inhibitor that targets checkpoint kinase 1 (CHK1) and CHK2. Undergoing tests in a potentially registrational phase II trial across multiple tumor types, ACR-368 also raised the stakes for Boundless Bio Inc., which is developing CHK1 inhibitor BBI-355.
Device recalls may seem an ordinary fact of life, given that some are declared for reasons as innocuous as a change of labeling, but the five device recalls announced by the U.S. FDA April 24 and 25 include one product withdrawal. The recall for the Nimbus series of infusion pumps and administration sets by Infutronix LLC cited instances in which patients were subjected to out-of-specification analgesia flow rates, and the company has seen fit to remove the existing inventory from the market.
In what represents just the third PCT filing to have been published in the name of Zurich, Switzerland-based Siva Health AG, protection is sought for a computer-implemented method of classifying an individual suffering from chronic cough.
The U.S. FDA’s device center launched a new health care program designed to provide patients with a seamless home health care environment that stitches together various health care functions into an integrated system that eases the patient’s use of such technologies. The initiative, part of the...
South Korean med-tech companies Nunaps Co. Ltd. and Share & Service are the latest to clear domestic approvals for digital therapeutics as the government ramps up R&D funding for artificial intelligence-based medical technologies.
Smart Reporting GmbH raised €23 million (US$24.5 million) in a series C funding round for its medical reporting software which automates and streamlines physicians’ workload. The funding is a “significant accelerator” for the company, “catalyzing business growth, product development, and expansion...
Crescom Co. Ltd., of Seongnam-si, Gyeonggi-do, gained domestic approval for its AI-powered software to grade knee osteoarthritis, dubbed MediAI-OA, while launching a new AI-mobile platform, Onzaram, to help manage child growth care.
Owlstone Medical Ltd. received $6.5 million in funding from the Bill & Melinda Gates Foundation which will go towards expanding its Breath Biopsy platform as well as developing breath-based diagnostic tests to identify breath biomarkers for tuberculosis and HIV.
Singapore- and U.S.-based Sunbird Bio Pte Ltd. is advancing its blood-based diagnostics platform for neurological diseases like Alzheimer’s and Parkison’s disease (AD/PD), amidst new breakthroughs in the AD drug therapies and diagnostics space.
Butterfly Network Inc. expanded its collaboration with the Clinton Health Access Initiative, Global Ultrasound Institute and the Bill & Melinda Gates Foundation to increase access to maternal/fetal ultrasound technology. The program will bring 500 IQ+ systems and ultrasound training to six...
Alzheimer’s disease (AD) is recognized worldwide for its debilitating symptoms of declining cognitive function and gradual memory loss. What remains less clear is exactly what causes the neurodegenerative disease, and how to treat it. “Alzheimer’s disease is characterized by two key pathologies –...
Bruker Corp. shows no sign of slowing its buying binge, picking up Nanostring Technologies Inc. for $392.6 million in cash plus the assumption of certain liabilities in its seventh deal so far this year.
Nanostring entered bankruptcy in February and received a “stalking horse” bid of $220 million...
The new merger guidelines released by the U.S. Department of Justice and the Federal Trade Commission have proven controversial on several fronts, but now the House of Representatives is weighing in. Rep. Roger Williams (R-Texas) said the guidelines fail to account for the importance of these...
As Johnson & Johnson's (J&J) first-quarter revenue missed Wall Street estimates for medical devices on April 16, CEO Joaquin Duato noted that the company will continue to look for major M&A plays to boost long-term growth in the wake of its recently reported $13.1 billion buy of Shockwave Medical Inc.
Med-tech powerhouse Johnson & Johnson made a bold bid to bolster its interventional cardiology holdings with the news on April 5 that it is acquiring Shockwave Medical Inc. for approximately $13.1 billion including cash acquired. The $335 per share cash price represents a more than 5% premium to...
Australia’s Competition and Consumer Commission said it will not oppose Cochlear Ltd.’s proposed acquisition of the cochlear implants business of Denmark’s Oticon A/S after the bone conduction businesses was removed from the deal.
Researchers have developed and validated a new technique that allows them to measure the lipid compounds in live cancer cells, one by one, according to a study published in the journal Analytical Chemistry. The new method paves the way for analyzing cells in greater detail to better understand...
Brain Trust Bio Inc. (BTB) will soon begin phase I trials in Australia of its IT-Riluzole delivered to the brain via a continuous intrathecal drug delivery method in people with amyotrophic lateral sclerosis. The company’s concept is to take known drugs that work and make them better by delivering...
The U.S. FDA granted fast track designation to Telix Pharmaceutical Ltd.’s TLX101-CDx for glioma imaging as the firm prepares to file its NDA in the first half of 2024, a Telix spokesperson told BioWorld.
Australia’s Therapeutic Goods Administration decided to take another look at the regulatory definition of the clinical decision support (CDS) system, a move driven by technological advances and some confusion as to what type of CDS is exempt from registration requirements.
Exact Sciences Corp. reported on data showing high sensitivity and specificity for the non-endoscopic Oncoguard Esophagus test that is currently in development for the detection of esophageal adenocarcinoma (EAC) and its precursors, including...
Eledon Pharmaceuticals Inc.’s tegoprubart, an investigational anti-CD40 ligand antibody, was used as part of the immunosuppressive regimen after the first-ever transplant of a kidney from a genetically modified pig to a human. The tegoprubart...
Serac Healthcare Ltd.’s imaging agent, 99m Tc-maraciclatide, enables visualization of early-stage endometriosis, preliminary data from a study presented last week at the Society for Reproductive Investigation conference in Vancouver demonstrated....
Affluent Medical SA said that its artificial sphincter, Artus, which treats stress urinary incontinence, was successfully implanted into the first patient. The company hopes that the device, which is the first artificial urinary sphincter that can...
Japanese researchers from Chiba University are spearheading new research into Peace of Mind Co. Ltd.’s portable Angel Touch device (AT-04), approved for neurological disorders, to treat endometriosis-related pain.
The Cardiovascular Research Technologies 2024 conference in Washington this week demonstrated continued positive outcomes for patients who underwent transcatheter aortic valve replacement with devices made by Abbott Laboratories, Edwards...
Breakthrough medicines, billion-dollar deals, spectacular clinical successes and crushing failures all play a part in biopharma’s dynamic story. Developers make scientific advancements with the potential to change everything, only to face regulatory conundrums and ever-fluctuating markets. BioWorld tracks key events in the fast-moving sector every business day. Now, the BioWorld Insider podcast lets you hear directly from the movers and shakers whose collective work is changing how we all live. Join us each week for a new conversation.