Avacta Group plc has continued its growth through M&A strategy with the acquisition of Coris Bioconcept Sprl, a developer of rapid diagnostic test kits, for an up-front cash consideration of £7.4 million (US$9.3 million). The Coris deal comes on the back of its £24 million purchase of Launch Diagnostics Holdings Ltd. in 2022, as Avacta works on building up its diagnostics division.
Philips and Masimo receive FDA clearance for advanced monitoring
Royal Philips NV and Masimo Corp. received U.S. FDA clearance that allows the activation of Sedline brain function monitoring, regional oximetry and carbon dioxide measurements in Philips Intellivue MX750 and MX850 patient monitors, which will streamline decision-making for clinicians by eliminating the need for separate pieces of monitoring equipment. The integrated equipment can help clinicians more quickly assess and monitor cerebral oxygenation, anesthetic sedation and patient respiratory performance using the same monitor.
Sea-Long Medical says FDA inspection ‘a good learning experience’
U.S. FDA inspections are not always a pleasant experience, particularly when the end result is a warning letter. One company, Sea-Long Medical Systems LLC of Waxahachie, Texas, says the experience was a positive experience in that the company’s new ownership gained an important appreciation for the necessary rigors of medical device manufacturing. The FDA inspection of Sea-Long ran from the latter part of August to early September 2022, during which the FDA investigator evaluated the site’s manufacture of devices designed to provide hyperbaric therapy. In all, the April 4, 2023, warning letter cited the company for 11 deviations from the Quality System Regulation, but also noted that the company had promoted the hyperbaric hood devices for uses not included in the 510(k) clearance for the devices. Sea-Long’s CEO and co-owner, Valarie Austin, told BioWorld that the warning letter addressed “issues that have now been handled and updated to the correct policies.”
China ramps up efforts to digitize health
China continues to ramp up efforts to digitize its health care system, as it moves closer towards a 2025 deadline that is part of a nationwide plan. Several of the country’s largest tech conglomerates now have digital health operations that are beginning to show profits and are expected to grow significantly over the next decade. From payments to food delivery, Chinese society has digitized quickly over the past decade. The government and various regulators are now looking to replicate those efforts in the health care industry, with digitization spreading across the country, supported by a range of technologies from telehealth to artificial intelligence. “China’s digital heath care industry is in the midst of an explosion,” Wu Jing, a researcher at consulting firm Leadleo, told BioWorld.
Follow-on offerings up year-over-year as overall med-tech financing value continues decline
Med-tech companies raised $8.65 billion in the first five months of the year, a decrease of 34.9% from the $13.29 billion raised in the same time frame last year. The number of deals is down 33.04% from last year, from 230 to 154. While the amount raised in private investments, IPOs and other public offerings is down, follow-on offerings increased to $3.1 billion, up from $1.73 billion in January to May of last year, a 78.5% jump.
Also in the news
Armis, Complete Genomics, Delfi Diagnostics, Illumina, Invivoscribe, Medcura, Microbot Medical, Miromatrix, Orthonika, Scandinova, Senseonics, Sophia Genetics, Treace