Sky Labs Inc. CEO and founder Jack Byunghwan Lee reported on plans to greatly expand the market for the company’s blood pressure monitor ring, including seeking regulatory approvals for the CART BP products in the U.S., Europe and Japan.
The European Association of Medical Device Notified Bodies inked a position paper on the EU Artificial Intelligence Act which recites some standing concerns. Perhaps the most interesting passage in the paper is that there is a need for a “well-coordinated approach between member states that are in charge of notified body oversight.”
Roche AG has become the latest pharmaceutical company to respond to the Trump administration’s threat to impose tariffs, saying it will invest $50 billion in drug and diagnostics manufacturing in the U.S. over the next five years. That figure matches a similar commitment by its Basel, Switzerland-based neighbor, Novartis AG, which on April 11 said it would be investing almost $50 billion in the U.S., also over the next five years.
The U.K. National Institute for Health and Care Excellence (NICE) gave the nod to a total of 11 robotic surgical systems for use in the U.K.’s trusts, but this is no free pass as the agency expects the manufacturers of these systems to gather data under this conditional coverage framework.
Newco Brink Therapeutics SAS is poised to work on the next chapter in genome editing after raising €3.5 million (US$4 million) in seed funding to discover and develop programmable recombinase enzymes.
Neuranics Ltd. recently raised $8 million in seed funding which is “extremely important” for the company as it looks to scale its magnetic sensing technology, which detects muscle activity without touching the skin, Noel McKenna, CEO told BioWorld. “The funds will help accelerate our go to market strategy and advance our R&D roadmap,” he said.
The Abu Dhabi health care company M42 is to make an investment in U.K.-based longevity specialist Juvenescence as a route to moving into drug discovery and development, with the two forming a partnership to work together on products that extend the healthy lifespan and improve the treatment of chronic diseases.
Oral peptide delivery specialist Cyprumed GmbH is about to find out if the high bioavailability of its tablet formulations seen in animal models will translate across to humans, after signing a $493 million license and option agreement with Merck & Co. Inc.
Receipt of EU MDR CE mark may not be a magic potion, but Elixir Medical Corp. is certainly feeling a boost from the regulatory nod for its mechanical Lithix hertz contact intravascular lithotripsy system for treatment of moderate to severely calcified coronary artery lesions. Simultaneously, the company reported the launch of Lithix and completion of first cases in Italy, France and Germany.
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