South Korean medical software firm Coreline Soft Co. Ltd. said it gained U.S. FDA 510(k) clearance for its artificial intelligence-based coronary artery calcification assessing solution, Aview CAC, while raising ₩18 billion (US$13.33 million) in a private placement.
Artificial intelligence (AI) is steadily making inroads into the world of health care, and San Francisco-based Eko Health Inc. has taken up the AI call with a stethoscope developed in conjunction with the Mayo Clinic that can detect low ejection fraction of the heart.
Asensus Surgical Inc. grabbed a $10 million lifeline from prospective suitor Karl Storz SE & Co. KG, which has offered to buy the cash-strapped company for 35 cents per share or about $96 million. Asensus signed a non-binding letter of intent to consider and negotiate terms after “an extensive period of consideration of various strategic alternatives.” Under certain circumstances, it could access a further $10 million from Storz prior to a merger. Asensus reported in March that its cash runway would tap out in early July.
Acorda Therapeutics Inc. has filed for bankruptcy and agreed to sell its assets, including rights to its three commercialized drugs, to German biopharma Merz Therapeutics GmbH for $185 million. Palo Alto, Calif.-based Eiger Biopharmaceuticals Inc. also filed for bankruptcy.
Yes, even a phase III protocol for a “failed” trial can constitute prior art, the U.S. Court of Appeals for the Federal Circuit told a lower court April 1 when it returned Janssen Pharmaceuticals Inc. and Teva Pharmaceuticals USA Inc.’s patent squabble for a do-over.
Trouble continues to dog Verve Therapeutics Inc.’s base editor of the PCSK9 gene, VERVE-101, so the company paused enrollment in a phase Ib study in cholesterol lowering to focus on the similarly designed VERVE-102.
Phase II/III results from Gritstone Bio Inc. with Granite, a personalized neoantigen cancer vaccine for colorectal cancer, turned up the opposite of what some investors expected, and the company’s shares (NASDAQ:GRTS) ended April 2 at $1.20, down $1.15, or 49%.
Jumping in for the first time to the hot antibody-drug conjugate (ADC) space, Paris-based Ipsen SA pulled in exclusive global rights to a preclinical ROR1-targeting candidate from Sutro Biopharma Inc. in a deal worth up to $900 million. STRO-003, the first ADC to join Ipsen’s portfolio, contains an anti-ROR1 human IgG1 antibody (SP-11385) conjugated to an exatecan warhead, or payload.
Angiodynamics Inc. said it has settled with the parent company of C.R. Bard Inc., over a series of conflicts over patents held by Bard that will cost Angiodynamics nearly $10 million just in 2024, potentially significantly more.
Abbott Laboratories reported the U.S. FDA approval of a new device specifically designed for the repair of leaky tricuspid heart valves. The Triclip was granted a PMA for the treatment of tricuspid regurgitation following the recent recommendation of the Circulatory System Devices Panel of the Medical Devices Advisory Committee for the FDA, whose vote confirmed 13 to 1, with 0 abstention that the benefits of Triclip outweighed the risks.
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