Mauna Kea Technologies has secured 510(k) clearance from the FDA for its laser endomicroscope Cellvizio 100 series F400 and F800 with the CranioFlex, a new Confocal Miniprobe, for use in neurosurgery.
Teleflex agreed to acquire Singapore-based QT Vascular's Chocolate XD, Glider and other nondrug-coated coronary products for an undisclosed amount. The deal, which still requires shareholder approval, includes an option for Teleflex to buy QT's in-development Chocolate Heart drug-coated coronary balloon catheter.
A round of financing supported by over 200 investors brought in approximately $4.67 million for Finnish molecular diagnostics company Mobidiag. The proceeds will be used to support the company's worldwide sales and marketing efforts and boost production of the Novodiag instruments and disposable cartridges.
A partnership deal was reached between Venus Medtech, a Chinese maker of heart valves, and Keystone Heart granting Venus exclusive rights to the development and sale of a third-generation version of Keystone's TriGuard 3 device in Asian markets. The companies previously teamed up to promote the Venus A-Valve TAVR system along with Keystone's first-generation TriGuard cerebral embolic protection device in those markets.
A marketing deal was reached by Agendia and Angsana Molecular & Diagnostics Laboratory allowing Angsana to market Agendia's MammaPrint and BluePrint breast cancer tests in Singapore, Vietnam, Brunei, Malaysia and Myanmar. The companies did not disclose additional terms of the agreement.
Foundation Medicine and Merck agreed to partner on the creation of companion diagnostic tests for Merck's anti-PD-1 immunotherapy drug Keytruda for undisclosed financial terms. The deal calls for the development of companion diagnostic tests for tumor mutational burden, a pan-cancer test for microsatellite instability measurement and additional novel biomarkers of response, all of which will use Foundation's FoundationOne CDx comprehensive genomic profiling assay for solid tumors.
A Crystal Market Research report predicts the spinal implant and surgical devices market will hit $15.7 billion by the end of 2025 with a compound annual growth rate of 4.44% because of technological advancement and the rising geriatric population. Among the key market players are Zimmer Biomet, DePuy Synthes, Medtronic, Stryker and Alphatec.
Six CE-marked diagnostic tests on Becton Dickinson's BD Max molecular diagnostics platform were launched by BioGX, expanding the menu for the platform to eleven tests. The tests can be used to diagnose viral meningitis HSV/VZV, bacterial meningitis ELGBS, bacterial meningitis NSH, carbapenem resistance KNO, vancomycin resistance and carbapenem/colistin resistance VGM.
The FDA authorized Imagen Technologies to market OsteoDetect, an artificial intelligence-based software for wrist fracture detection and diagnosis in adults. The software analyzes medial-lateral and posterior-anterior X-ray images of wrists using machine-learning techniques to identify signs of distal radius fracture and facilitates the diagnostic process by marking the location of the fracture on the image.
A survey of women who had undergone oocyte cryopreservation for nonmedical reasons between 2012 and 2016 found that most felt empowered by the decision, but about half had mixed feelings and 16% had serious doubts. The study, published in Fertility and Sterility, starts a conversation about "how this technology might impact the trajectory of women's lives," said co-author Eleni Greenwood.