Vicentra BV has closed a $74 million series C financing round to accelerate the European rollout of its wearable insulin patch. The small, lightweight system Kaleido is the company’s flagship product and consists of two pumps controlled by a Bluetooth wireless connected handset. The small size rests on a pumping action that – unlike a conventional syringe mechanism – uses micro-pulse technology to deliver accurate and consistent doses of insulin. Read More
Regulatory agencies across the globe had their hands full in 2020 and 2021 in responding to the COVID-19 pandemic, but that is just one reason that regulatory frameworks for artificial intelligence are lagging. Several regulatory proposals have been floated, but one of these hints at a need for regulatory harmonization, a requirement that seems certain to add yet more drag to a process that is already years behind the technology. Read More
A recently published study demonstrated that Viome Life Science Inc.’s metatranscriptomic signature for oral cancer identified the malignancy from samples of saliva with more than 90% accuracy. The mRNA platform received breakthrough device designation from the FDA in May for both early-stage oral squamous cell carcinoma and oropharyngeal cancer. Read More
V-Wave Ltd. said on Dec. 17 that it has closed all remaining tranches of a $98 million extended series C financing led by Deerfield Management. The funds will be used to complete a pivotal IDE trial for its Ventura interatrial shunt system for the treatment of advanced heart failure (HF) and submit a PMA to the FDA for U.S. marketing approval. Read More
Although 2021 med-tech deal volume is 13% higher than last year, the deals represent less than half the value recorded in 2020. The industry has completed 1,576 deals, including licensings, collaborations and joint ventures, through mid-December of 2021. They are valued at $2.13 billion. A total of 573 M&As, on the other hand, have reached $144.75 billion, a 282% rise over 2020. Read More
TORONTO – Hyperfine Inc. has received Health Canada approval for the first FDA-cleared portable magnetic resonance imaging (MRI) device, which also features advanced reconstruction deep learning software. The company simultaneously announced its commercial launch of the Swoop imaging system in Canada. Read More
Top-line data from Bellerophon Therapeutics Inc.’s phase II study of its pulsed inhaled nitric oxide technology, Inopulse, showed decreases in mean pulmonary arterial pressure and pulmonary vascular resistance (PVR) in treating pulmonary hypertension associated with sarcoidosis. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Firstkind, Implicity, Roche, Sky Medical Technology. Read More
