General Electric Co. reported it is dividing the company into three parts, with the tax-free spin-off of its GE Healthcare unit in early 2023 and a renewable energy and power company in 2024 leaving the legacy GE company as an aviation-focused business. The company plans to retain a 19.9% stake in GE Healthcare and GE Chairman and CEO H. Lawrence Culp, Jr., will serve as non-executive chairman of the health care company. Peter Arduini will become president and CEO of GE Healthcare effective Jan. 1, 2022.

China’s regulator raises requirements for internet health care industry

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. “This is actually a follow-up of several regulations the NHC released in 2018 and makes clearer requirements,” a manager at internet health care platform We Doctor Holdings Ltd. told BioWorld.

Message to small players in digital health space: Read FDA guidances first

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 the raft of agency guidances 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.

Ultrasound companies team up for transatlantic heart disease partnership

Ultrasound companies, Caption Health Inc. and Ultromics Inc. are linking up to jointly offer Caption’s AI software platform with Ultromics’ Echogo deep ultrasound analytics for early cardiovascular disease detection. The partnership comes on the heels of a partnership Brisbane, Calif.-based Caption inked with Butterfly Network Inc., the developer of Butterfly iQ+, a hand-held whole-body ultrasound system. According to a recent study, 46% of patients in the U.S. diagnosed with heart failure in acute care settings had potential symptoms that went undetected at primary care in the previous six months. The issues were more prevalent among women and black patients.

CDSCO relaxes compliance timelines due to COVID-induced regulatory drag

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 regulatory delay club as well. CDSCO reported recently that device makers that filed for market access under the 2017 regulatory overhaul by April 18, 2021, can continue marketing their products through June 30, 2022, even if those regulatory filings are incomplete, providing much-needed regulatory relief for industry.

Also in the news

Anavasi, Anpac, Airrosti, Bluejay, Brain Scientific, Capstar, Carrum, Cue, DNA Script, Endologix, Evaxion, Flume, Flywheel, Gelesis, Heartvista, Hinge, Imbed, Luna, Nanomesh, Pixcell, Pluristem, Protenus, Rad AI, Readyset Surgical, Regenxbio, Rockley Photonics, Synaps Dx, Teknova, Tela, Think Surgical, Vektor