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. Read More
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. Read More
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. Read More
Does the NIH have the ability to screen for U.S. security issues in its award of research grants? That question is at the heart of an April 2 letter the Republican leadership of the House Energy and Commerce Committee sent to the Government Accountability Office in which it asked the government watchdog to examine the extent to which the NIH “adequately safeguards research funds from national security concerns related to the Chinese military or over the unethical use of human beings in research studies, especially from entities of concern in China.” Read More
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. Read More
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. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Glaukos, Helius, Icad, Inspira, Moon Surgical, Organogenesis, Pixcell Medical. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Hemosonics, Venus. Read More