As a follow-up to the Biden administration’s executive order for artificial intelligence (AI), the U.S. Office of Management and Budget (OMB) has promulgated a memorandum directing federal government agency use of AI.
The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) has converted its regulatory sandbox for artificial intelligence (AI) into a full-fledged program dubbed the AI-Airlock, described as a regulatory-monitored virtual area in which industry can “generate robust evidence for their advanced technologies.” MHRA said it is focused on ensuring that AI products are available in the U.K. “before they are available anywhere else in the world,” a sign that national economic competitiveness is fostering a regulatory willingness to deal with uncertainty about this class of products.
Immuone Ltd. raised £2 million (US$2.4 million) to fund expansion of its operations to meet growing demand for its 3D human lung model. The company is hoping that its model will replace animal testing which is not always accurate at predicting the impact of drugs on humans. The funding came from the MEIF Proof of Concept & Early Stage Fund, Mercia’s EIS funds and Pioneer Group.
Conncons GmbH filed for patent protection of its networked medical infusion systems. The connecting components of their infusion systems house sensors that can detect data associated with medications in drug reservoirs.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Embolx, Girlow, Medicom, Motus, Prenetics, Shuttle Pharmaceuticals.
The U.S. FDA’s draft rulemaking for regulation of lab-developed tests (LDTs) came with a conspicuously short comment period of 60 days, but the agency is unresponsive to requests to add another 30 days to the comment period.
There’s nothing scary for Ametek Inc. shareholders in the $1.9 billion acquisition of Paragon Medical Inc. announced on Oct. 31, 2023. The deal moves the industrial technology company solidly into the med-tech space as it picks up Paragon’s portfolio of products in orthopedics, minimally invasive surgery, robotic surgery and drug delivery, and adds an estimated $500 million per year in revenue and “very strong EPS accretion,” Ametek CEO David Zapico said in an investor call on Oct. 31.
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