In a sweet indication of an improving capital market for med-tech companies, Biolinq Inc. landed $58 million in bridge financing to support completion of the U.S. pivotal trial of its intradermal glucose sensor and submission to the U.S. FDA. The round brings the total raised to more than $170 million. With good response so far, the company is optimistic that it can attract more funding in short order. “Biolinq also plans to raise a series C financing of more than $100 million to support commercialization at the end of this year,” Biolinq CEO Rich Yang told BioWorld.
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.”
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Glaukos, Helius, Icad, Inspira, Moon Surgical, Organogenesis, Pixcell Medical.
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.