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.

With the world experiencing another wave of the coronavirus pandemic that threatens to overwhelm hospitals and testing capacity, the ability to quickly diagnose COVID-19 based on alternative methodologies has become increasingly important. For patients with respiratory symptoms, review of CT scans emerged as a relatively reliable indicator of infection with SARS-CoV-2 from the first days of its emergence, but the need for more accurate readings remains.

The U.S. FDA has granted 510(k) clearance to Siemens Healthineers AG for AI-Rad Companion Organs RT, the newest module in its platform of artificial intelligence-based software assistants. The radiation therapy planning aide joins earlier AI-Rad Companion modules for interpreting magnetic resonance imaging (MRI) studies of the brain and prostate, as well as one for chest computed tomography (CT) studies.

HONG KONG – Aprinoia Therapeutics Inc. is poised to start phase III clinical trials for its positron emission tomography (PET) imaging tracer 18F-APN-1607 in China, after receiving the green light from the National Medical Products Administration.

Aidoc Inc., a provider of artificial intelligence (AI) solutions in radiology, has won U.S. FDA clearance to market the first software solution for flagging and triaging incidental pulmonary embolism (PE). The AI technology, which includes triaging and notification algorithms, is an “always on” technology that analyzes chest CT scans in real time and alerts the radiologist to any potentially abnormal findings – possibly speeding up diagnosis by hours.

Spectrawave Inc. has named Eman Namati as its CEO with the charge of commercializing its flagship cardiac imaging technology. The 3-year-old, Bedford, Mass.-based medical imaging company has set an ambitious 24-month timeline for getting its photonic imaging technology for coronary artery disease into the clinic.