Pfizer Australia Holdings Pty Ltd. has made an offer to acquire digital health company Resapp Health Ltd. in all cash offer worth AU$100 million (US$74.25 million). The two companies have entered into a binding scheme that is contingent upon shareholder agreement and regulatory clearances in Australia. Shareholders will vote on the proposed acquisition in June, and directors have unanimously recommended that shareholders vote in favor of the acquisition. Read More
Boston Scientific Corp.’s image-guided programming software, Vercise Neural Navigator with Stimview XT, got the green light from the FDA for use with the company’s deep brain stimulation (DBS) portfolio in patients with essential tremor or Parkinson’s disease. The software, developed in a collaboration with Brainlab AG, provides more sophisticated image-guided programming tools for personalization of the stimulation therapy, halving the time needed for adjustments and increasing precision. Read More
Newstem Ltd. filed a presubmission to the U.S. FDA for a de novo request and an in vitro diagnostic device with the EMA for its Newstem software diagnostic device (NSDD). The bioinformatics-based platform is a personalized diagnostic to inform oncologists about the presence of mutations in tumors and predict a patients’ resistance to chemotherapy treatments. The technology utilizes specialized stem cells (haploid cells) that carry just one set of chromosomes. Read More
Telix Pharmaceuticals Ltd. has in-licensed Eli Lilly and Co.’s olaratumab antibody, agreeing to pay $5 million up front for exclusive worldwide rights to develop and commercialize radiolabeled forms of the antibody for the diagnosis and treatment of human cancers. Read More
For the second time in four years, the FDA has issued a draft guidance for cybersecurity in premarket applications, just one of several actions undertaken recently by the U.S. federal government in connection with cybersecurity. Read More
Semiconductors chips, a key component in many medical devices, continue to be in short supply as COVID-19-driven supply chain disruptions continue. The shortage comes at the worst possible time, with demand for the chips on an upward trend. Nano-x Imaging Ltd.’s (Nanox) solution to the shortage was to open a semiconductor chip fabrication plant in Yongin, South Korea, to produce Nanox.source, a semiconductor chip that replaces the filament in the analog X-ray tube. Read More
The FDA program for third-party review of 510(k) applications was designed to take some of the load off the agency’s review staff and thus allow the agency to focus on more complex filings, but recent data suggest that the program has had only a modest effect on the FDA’s workload. The number of third-party reviews for the current and two previous fiscal years only modestly exceed the numbers from fiscal years 2018 and 2019, a conspicuous trend given the distractions at the FDA’s device arising from its work to manage the COVID-19 pandemic. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: APR Medical, Assure Holdings, Bearpac Medical, Cline Scientific, Eaglepicher, Exergen, Infandx, Lifespin, Masimo, Resonetics, Sound United. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biocardia, Boston Scientific, Novacyt, Transit Scientific. Read More
