Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Edwards Lifesciences, Neuronetics, Organox.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Affera, Cytosorbents, Magforce, Vesper, Xeltis, Zynex.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: CMR Surgical, Cooper, Generate, Gulf Drug, Lightsense Technology, Pi-Cardia, Strategic Group International.
The U.K.’s National Institute for Health and Care Excellence (NICE) will welcome a new chief executive in February. Samantha Roberts was named to succeed Gillian Leng, who is retiring after 20 years at the agency. With extensive experience in health care delivery and as a clinician, Roberts currently serves as managing director for health and care at NHS England.
The European Council reached an agreement Dec. 20 that will allow the European Health Emergency Preparedness and Response Authority to respond much more quickly to public health emergencies such as the COVID-19 pandemic by activating urgent and targeted medical countermeasures (MCMs) across the EU.
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.
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.
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.
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.
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