With the spotlight at this week’s Alzheimer’s Association International conference firmly fixed on the first approved therapies, advances in diagnosing the neurodegenerative disease - on which effective use of new drugs will hang - attracted less attention. However, hand-in-hand with the development of anti-amyloid drugs, development of blood-based biomarkers has made significant progress and they now have the potential to form the basis of easy to access and low cost tests. Read More
Anbio Biotechnology Ltd. launched the Anbio AF-100S, an automated, compact and affordable fluorescent immunoassay (FIA) solution that it hopes will transform the field of clinical diagnostics and empower healthcare providers. The AF-100S FIA is a handheld point-of-care immunodiagnostic solution that provides rapid, accurate and reliable results for a wide range of analytes. Read More
Taking a step forward in an increasingly crowded market that has long been dominated by non-Chinese players, Magassist Co. Ltd. got positive clinical results from its extracorporeal membrane oxygenation (ECMO) system Breathmo to provide support for patients with serious heart failure or lung failure, with a study showing that the system can provide pulmonary and cardiac support effectively and safely. Read More
While med-tech financings in the second quarter (Q2) rose by 24% over the first quarter (Q1) – an historically low Q1 – the overall funding landscape in 2023 has struggled to keep up with other years, with IPOs in particular hitting rock bottom. A total of $5.8 billion was raised in Q2 through 128 transactions. Combined with Q1, the amount for the first half of 2023 is $10.5 billion through 255 transactions. This is an overall drop in value during the first six months of 31% compared with the same timeframe in 2022. It also is down from 2017 – the next lowest year – by 22%. Read More
Summer is the time when device makers press their cases for add-on and pass-through payments from the Medicare program, and this year’s draft hospital outpatient prospective payment system for calendar year 2024 is no exception. Both Cook Medical and Philips North America are pushing CMS for new technology pass-through (NTPT) payments for their offerings, but these two larger firms have a lot of company in the NTPT sweepstakes. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aevice Health. Read More
