The FDA has approved Roche AG’s Ventana MMR Rxdx panel for patients with advanced or recurrent endometrial cancer. The companion diagnostic is the first to identify patients who are eligible for treatment with Glaxosmithkline plc’s (GSK’s) Jemperli (dostarlimab-gxly) monotherapy. The PD-1 antibody immunotherapy received FDA approval on Thursday. Read More
LONDON – Med-tech investor Endeavour Vision reported the final close of its Medtech Growth II fund at $375 million. The fund will invest in commercial stage companies with products that advance the standard of care or bring efficiencies to how health care systems operate. That strategy is expected to result in two-thirds of the money going into device companies and the remainder to digital health specialists. Read More
The Supreme Court heard the case of Minerva Surgical Inc. v. Hologic Inc., which takes up the question of assignor estoppel for patents, but the discussions that peppered the April 21 hearing lent little clarity as to how the nine justices will decide the case. Read More
Onward NV secured $32 million in a new financing round led by Invest-NL and Olympic Investments. All the company’s existing investors also participated in the round, including medical technology investors LSP, Inkef Capital, Gimv, and Wellington Partners. The new funds will support Eindhoven, Netherlands-based Onward's development and commercialization of its Arc-Im and Arc-Ex spinal cord systems, designed to provide targeted spinal cord stimulation to help people with spinal cord injuries regain movement and independence. Read More
PARIS – Imageens SAS just raised a $1.4 million seed round to develop its two artificial intelligence (AI) systems in the field of medical imaging in Europe. Its first solution Artfun+, an AI software application, makes it possible to anticipate cardiovascular pathology thanks to new prognostic biomarkers. Its second product is Label, an algorithm which automatically classifies and assesses medical imaging data. Read More
Med-tech firms raising money in public or private financings, including: Aspetiscope, Edap Tms, Nerv Technology, Ronovo Surgical, Treace Medical Concepts. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbott, Cloud Dx, Dhl Holdings, Emed, Illumina, Inter Medico, Jolly Good, Kartos Therapeutics, McKesson, Premier, Quidel, Sight Diagnostics, Spacelabs Healthcare, Teijin Pharma. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Roche. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Alivecor goes to ITC in patent scrum with Apple; Cordis carotid artery stent recalled; C-Rad snares court win for patent; Orthotics supplies subject of $65M in fraud. Read More
Keeping you up to date on recent developments in neurology, including: Fast brainwave oscillations identify, localize epileptic brain; Sleep biomarkers linked to neurodegenerative disease; Autophagy chaperone targets aggregation-prone proteins. Read More
