Avanos Medical Inc. is acquiring Orthogen Rx Inc. for $160 million in a bid to strengthen its chronic pain portfolio. China led the contribution to India’s med-tech imports with ₹91.12 billion (US$1.2 billion) worth of goods in the 2021 fiscal year (April 2020 to March 2021), according to an analysis of data from India’s Department of Commerce by the Association of Indian Medical Device Industry (AIMED). Read More
Cardiologist Robert Califf has been nominated a second time to lead the FDA, and drug pricing was again high on the agenda at the Dec. 14 Senate hearing for his nomination. Read More
The FDA has granted approval to Urotronic Inc. for its Optilume urethral drug-coated balloon (DCB) for the treatment of male urethral strictures. The device inhibits new scar tissue growth that may form after endoscopic dilations via the controlled release of paclitaxel, an antiproliferative that inhibits scar tissue formation. Read More
The FDA added its green light to Klox Technologies Inc.’s Lumiheal fluorescent and blue light therapy system with de novo clearance for scar management of post-surgical incisions. The system uses fluorescence biomodulation technology to activate cellular processes and treat skin and soft tissue disorders. Read More
Even as it strives for self-reliance, India is struggling to wean itself off a reported 75% increase in med-tech imports from China. China led the contribution to India’s med-tech imports with ₹91.12 billion (US$1.2 billion) worth of goods in the 2021 fiscal year (April 2020 to March 2021), according to an analysis of data from India’s Department of Commerce by the Association of Indian Medical Device Industry (AIMED). Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Bracco Imaging, Guerbet, Ganzimmun, Heartflow, Icad, Labtech Diagnostics, Mainz Biomed, Ortho Regenerative, Quest Diagnostics. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bridge to Life, Healthtrackrx, Klox, Medtronic, Roche. Read More