Makers of medical devices already have a substantial series of requirements related to cybersecurity, but those requirements may increase per a draft rule released by the U.S. Cybersecurity and Infrastructure Security Agency.
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.
In a departure from its focus on using implanted electrodes to treat urinary incontinence, Amber Therapeutics Ltd. has filed for protection of similar approaches to treat sexual dysfunction and pelvic pain.
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.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Hemosonics, Venus.
Alzheimer’s disease (AD) is recognized worldwide for its debilitating symptoms of declining cognitive function and gradual memory loss. What remains less clear is exactly what causes the neurodegenerative disease, and how to treat it. “Alzheimer’s disease is characterized by two key pathologies – beta-amyloid plaques and tau neurofibrillary tangles.” Seung-Yong Yoon, CEO of Adel Inc., told BioWorld. “Adel is looking to develop a tau-targeting drug, considering tau has been more correlated with AD symptom progression, and the industry’s need for tau pipelines.”
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Concept Medical, Eko Health, Quidelortho Thorne Healthtech, Wat Medical.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: GE Healthcare, Harrick Scientific, Icecure, Kardium, MIM, Onward Medical, Precisedx, Specac, Zoll Medical.
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