Sema4 Holdings Corp., Illumina Inc. and Pear Therapeutics Inc. joined a growing list of med-tech companies responding to what Pear CEO Corey McCann called a “challenging macroenvironment” by spinning off, selling or shuttering non-core lines of business and slimming payroll.
Stimulating the brain via implanted electrodes is used to treat both movement disorders such as Parkinson’s disease, and some psychiatric conditions such as obsessive compulsive disorder. But researchers are also working on ways to make such implanted electrodes listen instead of talk – and translate neuronal signals for people that have lost the ability speak, or the ability to move.
The first home pregnancy test to analyze saliva rather than urine is due to be on the shelves in Europe at the start of 2023, following CE approval of Salistick, developed by saliva diagnostic specialist Salignostics Ltd.
After getting its 510(k) application rejected by the U.S. FDA for its AI-enabled Salix coronary anatomy software (SCA), Australian medical technology company, Artrya Ltd. scored regulatory approvals in the UK and in the EU.
Surgical teams from the Department of Oncology at Toulouse University Hospital and the Cancer University Institute of Toulouse Oncopole have achieved a total reconstruction of a patient’s nose using a 3D-printed synthetic graft previously implanted in her forearm to pre-vascularize it.
Shanghai Junshi Biosciences Co. Ltd. has submitted a new drug application (NDA) for its anti-PD-1 monoclonal antibody toripalimab to the European Medicines Agency, which marks the first NDA filing of toripalimab in Europe.
Britain’s National Institute for Health and Care Excellence (NICE), a key gatekeeper on the path to the U.K. market, is backing away from five COVID-19 treatments. No longer recommended in a draft guidance were Ronapreve (casirivimab + imdevimab) from Roche Holding AG, Xevudy (sotrovimab) from GSK plc, and Evusheld (tixagevimab + cilgavimab) from Astrazeneca plc. NICE also recommended discontinuing use of Lagevrio (molnupiravir) from Merck and Co. Inc. and Veklury (remdesivir) from Gilead Sciences Inc.
Medtronic plc’s new Extended infusion set shows the advantages of tending to details. Tubing doesn’t get much respect, but the changes Medtronic made to its set will substantially reduce the burden of disease management for patients with diabetes who use insulin pumps. The Medtronic Extended infusion set can be used for up to seven days, more than doubling the time between changes. The changes also sharply reduced insulin loss, resulting in a 25% reduction in waste of the increasingly expensive medication.
The government in France has just launched the Health Innovation Agency. This new government agency aims to improve identification of future health technology and better anticipate the impact of innovation in France.
Samantree Medical SA has published clinical data demonstrating a significant reduction in re-operations in breast-conserving surgery using its novel ultra-fast confocal microscopy technology. The study on its medical imaging platform, the Histolog scanner, has just been published in The Breast.
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