General Electric Co. reported that it was dividing the company into three “well capitalized investment-grade companies with seasoned leadership teams.” The division of the huge conglomerate will start with the tax-free spin-off of GE Healthcare Ltd. in early 2023 and the renewable energy and power business in 2024 leaving the legacy GE as an aviation-focused enterprise. The company will take a one-time hit of $2 billion in connection with the split up. Read More
Entities that lack experience in FDA regulation of medical devices may find the going both expensive and time consuming, but there are resources available to these players in the digital health space. Bakul Patel, director of the Digital Health Center of Excellence at the FDA’s device center, said that while he understands that reading through agency guidance is an unpleasant task, the companies that take the time to do so may find their interactions with the agency less iterative and more productive, thus speeding their path to market. Read More
China's National Health Commission (NHC) has released a draft regulation to set entry requirements for the internet health care industry. The draft poses some strict requirements, such as a ban on online consultations for the initial diagnosis. It also prohibits the practice of linking doctors’ income to the sales of drugs and medical devices. Read More
Ultrasound companies, Caption Health Inc. and Ultromics Ltd. are linking up to jointly offer Caption’s AI software platform with Ultromics’ Echogo deep ultrasound analytics for cardiovascular disease detection. Read More
LONDON – A pilot study has shown that whole genome sequencing can pinpoint the genetic causes of rare diseases, even in people who had previously not been given a diagnosis after undergoing sequencing of their protein coding exome. Read More
India is home to just one of several regulatory entities that have overhauled their med-tech regulatory apparatus in recent years, but the Central Drugs Standard Control Organization (CDSCO) has also joined the COVID-19 regulatory delay club as well. Read More
New hires and promotions in the med-tech industry, including: Alpha Teknova, Brain Scientific, Carrum Health, Endologix, Flume Health, Readyset Surgical, Think Surgical. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: ADL Diagnostics, Airrosti, Anavasi, Atos Medical, Capstar, Coloplast, Cue Health, DNA Script, Gelesis, Imbed Biosciences, Luna, PAI Partners, Pixcell, Pluristem, Rockley Photonics, Synaps Dx. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Heartvista, Vektor Medical, Siemens Healthineers. Read More
