On March 1, Boston Scientific Corp.’s Agent drug-coated balloon (DCB) became the first DCB to gain U.S. FDA approval for treatment of in-stent restenosis in patients with coronary artery disease. With more than 100,000 patients already treated in Europe, Latin America and Japan, it’s no secret Agent provides significant benefit compared to balloon angioplasty or drug-eluting stents (DES) for the approximately 10% of patients with coronary stents who experience subsequent narrowing of the treated vessel.

South Korea’s Cell & Growth Factor Biotechnology Co. Ltd. (CG Bio) became the largest shareholder of Busan-based Inosys Korea after claiming a 34.7% stake in the embattled orthopedic implant med-tech firm.

With the number of people with dementia in Australia expected to nearly double by 2054, the federal government is funding a new AU$50 million (US$32.76 million) biomedical and med-tech incubator program to develop new therapies, medical devices and digital health technologies to address dementia and cognitive decline.

Australia’s Therapeutic Goods Administration (TGA) proposed in July 2023 to develop a framework for audits for premarket device applications, but the Medical Technology Association of Australia (MTAA) registered several concerns about the proposal.

A new cutting-edge blood-based biomarker test developed by researchers at Hong Kong University of Science and Technology can detect early Alzheimer’s disease (AD) and mild cognitive impairment (MCI), with accuracy rates surpassing 96% and 87% respectively, and could be a game changer in detecting and treading early AD.

South Korea’s MFDS gave regulatory clearance to SK Inc. C&C’s artificial intelligence (AI) solution to diagnose cerebral infarction called Medical Insight+ Brain Infarct on Feb. 22, as a class III device.

Sky Labs reported it has more comparative study data to back its ring-type medical device for blood pressure (BP) called CART BP, which CEO Jack Lee noted has the potential to “replace existing blood pressure monitors.” Sky

The U.S. FDA approved a new feature for detecting obstructive sleep apnea (OSA) on the Samsung Galaxy watch and smartphone, Samsung Electronics Co. Ltd. said on Feb. 10.

Vision Care Group CEO Masayo Takahashi led the world's first clinical study of a retinal cell transplant derived from induced pluripotent stem cells (iPS cells) in 2014 when she led the Laboratory for Retinal Regeneration at Japan’s Riken Center for Biosystems Dynamics Research. In 2019, she founded Vision Care and subsequently founded two subsidiary companies dedicated to developing cell and gene therapies.

South Korea’s CU Medical Systems Inc. has applied for protection of a system that combines features of a cardiopulmonary resuscitation (CPR) device and an automatic external defibrillator (AED) and uses chest impedance measurements to optimize emergency treatment.