Innerscope Hearing Technologies Inc. acquired the assets and operations of Ihear Medical Inc. for an undisclosed amount. The deal significantly boosts Innerscope’s position in the emerging market of direct-to-consumer and over-the-counter hearing products, an important development in the run-up to the FDA’s expected release next month of new regulations for hearing aids that can be sold in stores without a prescription. Read More
The FDA’s final rule for the de novo petition process took nearly three years to wrap up, a timeline likely extended by the COVID-19 pandemic, but the final rule retains some controversial features seen in the 2018 draft. Among these is a provision for FDA inspections before determining whether to grant the petition, a provision that was blasted by multiple commenters as extra-statutory and a needless source of drag on these applications. Read More
It may be a small country, but Lithuania has lofty ambitions. The Baltic country is emerging as one of Europe’s rising life science stars, with annual growth of 22% and targeting 5% of its GDP to be generated by the life sciences sector in 2030. Export of medical devices has also doubled since 2008, with majority of the country’s production reaching the U.K., France, Russia, Spain and the U.S. Read More
Francis Collins, perhaps one of the U.S.’ biggest cheerleaders for the promise of medical science, announced Oct. 5 that he will be ending his nearly 13-year tenure as NIH director by the end of the year, but he won’t be hanging up his lab coat. The 71-year-old Collins will continue to lead his research lab at the NIH’s National Human Genome Research Institute. Read More
Through a series of notifications, India’s drug regulator has classified a new batch of medical devices as well as a range of software used in medical devices according to risk, taking another step to strengthen regulatory oversight and shore up the domestic med-tech sector. Read More
Advocates have continued to press for more widespread use of rapid antigen tests in the home as a primary instrument for returning to economic normalcy, and the FDA has granted an emergency use authorization (EUA) to Acon Laboratories Inc., of San Diego, for the company’s Flowflex rapid antigen test for at-home use. According to the FDA, Acon said the COVID-19 test will be produced at a rate of 200 million a month by February 2022, a clip that should go a long way toward restoring vigor to a lagging U.S. economy. Read More
New hires and promotions in the med-tech industry, including: Asensus Surgical, Cathworks, Colospan, HTG Molecular Diagnostics, Mogrify, Seqwell, Spencer Health Solutions. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aidoc, Allscripts, Caremetx, Esight, Fluidfile, Merlin Entertainments, Riverain Technologies, Samsung Electronics, Sonendo, Veradigm, Vuno. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acon Labs, Amber Implants, Iotamotion, Nyxoah. Read More
