Spectrawave Inc. has scooped up $13.2 million in a series A-2 financing led by prior investor Deerfield Management. The funds will be used to complete development and regulatory filing for its flagship cardiac imaging technology. Prior unnamed seed investors also participated in the round. With this latest infusion, Spectrawave has raised a total of approximately $30 million to date.

LONDON – The U.K. National Institute for Health and Care Excellence (NICE) has published new advice on how and when artificial intelligence (AI) could be applied to the interpretation of mammograms and chest computer tomography images, in a move that is intended to set the ground rules for the uptake of these technologies. In population breast screening, NICE looked at how five AI systems could be used to pick out mammography images that need further assessment, supporting qualified radiologists in their interpretation.

TORONTO – Calgary-based Circle Cardiovascular Imaging Inc. is receiving CA$2.65 million (US$2.09 million) in funding from the Canadian government’s Western Diversification Program (WDP), which represents nearly half of the more than CA$5.5 million (US$3.35 million) investment made to four Alberta-based organizations and companies. Company CEO Greg Ogrodnick attributes this to Circle Cardiovascular’s position “as the world leader in cardiovascular imaging.”

Longeviti Neuro Solutions LLC has received the U.S. FDA’s nod for use of its Clearfit cranial implant with postoperative ultrasound imaging. The expanded 510(k) clearance could help in reducing radiation exposure linked to other post-neurosurgical imaging modalities. Research has shown that current methods of post-neurosurgical imaging put patients at risk of radiation exposure, and that an estimated 29,000 future cancers could be linked to CT scan used in the U.S. each year. Comprised of polymethyl-methacrylate (PMMA), Clearfit is a neuro-reconstructive implant that surgeons use to reconstruct a patient’s cranium following brain surgery.

One in five breast cancer conserving surgeries leaves behind some of the tumor. That means patients must schedule a second surgery and then endure additional pain, infection risk, recovery time and cost. Cairnsurgical Inc.'s Breast Cancer Locator system may change that by providing 3D tools that enable surgeons to precisely tailor resection to the shape, size and location of each tumor.

HONG KONG – South Korea’s Ministry of Food and Drug Safety (MFDS) has greenlighted Seoul-based Vuno Inc.’s artificial intelligence (AI)-based solution Vuno Med Deepbrain for use as a class III medical device, which is a classification for moderate risk level devices. The MFDS approval was given on Dec. 29, 2021, a Vuno spokesperson told BioWorld, but the company only disclosed the approval earlier in the week. The reasons for the delayed announcement were not disclosed.

Alphatec Holdings Inc. has renewed a commitment to buy Eos Imaging SA, saying it will now pick up the company for $79.7 million, plus the retirement of $37.2 million in debt, in an all-cash deal. Both company’s boards have approved the execution of a tender offer agreement, through which Carlsbad, Calif.-based Alphatec will launch a cash tender offer for all the issued and outstanding shares and convertible notes of Eos imaging for a total purchase price of $116.9 million.

PARIS – Braintale SAS has completed a $1.2 million seed round towards its portfolio of digital quantification and prediction medical devices for neurology and intensive care. This funding round, including a loan from Bpifrance, attracted investment from business angels, as well as industry and health care professionals.

Genetesis Inc. received good news from the U.S. FDA in the form of a breakthrough device designation for Cardioflux for the diagnosis of myocardial ischemia and infarction in patients with symptoms suggestive of acute coronary syndrome. Mason, Ohio-based Genetesis provides biomagnetic imaging solutions with an eye toward ensuring safety. Its solution already has made an impression on clinicians.

Olympus Corp. has unveiled its plans to acquire Veran Medical Technologies Inc. for up to $340 million. The buy will go through Olympus Corp. of the Americas (OCA) and is part of the company’s corporate strategy revealed in November 2019. It marks the second M&A-related announcement in about a month.