Perkinelmer Inc. is looking to bolster its life sciences offerings with the purchase of cell engineering company Horizon Discovery Group plc for $383 million. The all-cash acquisition will add gene-editing and gene-modulation tools to Perkinelmer’s existing portfolio of discovery and applied genomics solutions. Headquartered in Cambridge, U.K., Horizon provides CRISPR and RNA interference (RNAi) reagents, cell models, cell engineering and based editing products to aid in drug discovery and development. Read More
Boston Scientific Corp. has scooped up an approval from the U.S. FDA for the Ranger drug-coated balloon to help those with peripheral artery disease in the superficial femoral artery and proximal popliteal artery. Read More
Intersect ENT Inc., a sinusitis implant company, reported $22.7 million in third quarter revenue, driven largely by a rebound in procedures with its Propel implants for chronic rhinosinusitis. This figure marks a 6% decline from the $24.1 million reported in the third quarter of 2019. Read More
Patient perspectives on medical device development are becoming much more central to the U.S. FDA’s regulation of devices, thus the August 2020 draft guidance for selection of patient-reported outcome (PRO) instruments for device evaluation. However, the draft is sufficiently vague on the question of when an existing PRO can be tweaked without an entirely new validation study to prompt the Advanced Medical Technology Association (Advamed) to press the agency for more clarity on that point. Read More
Castle Biosciences Inc.'s Decisiondx Diffdx-Melanoma test is now commercially available to help dermatopathologists better characterize melanocytic lesions. About 15% of suspicious pigmented skin lesions cannot be definitively determined to be benign or malignant using common methods. The new gene expression profile test reduces the number of indeterminate results by more than 70%. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: HHS announces testing agreements; TGA slaps two companies for violations. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 1health.io, Aseptiscope, Becton, Dickinson and Co., Butterfield Engineering, Certtech, China Grand Pharmaceutical and Healthcare Holdings, Dante Labs, Drawbridge Health, Exagen, Fluidigm, Healthcare Merger Corp., Heraeus Medical Components, Hologic, Hygea, Implantica, Lidco, Masimo, Mimedx, Parexel, Polarityte, Poseida Therapeutics, Pulse Systems, Soc Telemed, Synexa Life Sciences, Telix Pharmaceuticals. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Boston Scientific, Brighter. Read More
Keeping you up to date on recent developments in cardiology, including: Mobile smartphone tech tied to better clinical outcomes for OHCA; Lung scans for earlier COVID-19 detection; Cholesterol meds affects the organs differently. Read More
