Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Femdx Medsystems, Getinge.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbott, Equipped MD, G Medical Innovations, Hemex Health, Medinbox, Micare Path, Spectral MD.
Previse, formerly known as Capsulomics Inc., raised $3 million in seed financing to support the launch of its first laboratory-developed test (LDT), Esopredict. The precision medicine test is designed to detect Barrett’s esophagus (BE) and predict which BE patients will progress to esophageal cancer.
Bellaseno GmbH and Evonik Industries AG joined forces to commercialize 3D-printed scaffolds used in bone regeneration. The scaffolds are made with Evonik’s Resomer polymers to address large and complex bone defects as an alternative to frequently less stable conventional methods.
Startup Aiomic ApS received a capital injection in the form of a €1.3 million (US$1.4 million) convertible loan from Denmark’s Bioinnovation Institute (BII) that will allow the company to further develop and commercialize its artificial intelligence (AI)-driven Aiomic360 platform, which is designed to reduce the number of postoperative complications.
The U.S. FDA’s December 2022 draft guidance for human factors (HF) information in medical device premarket filings is a complete do-over of a previous draft guidance from 2016, but the reaction from industry has been anything but cheerful. Several observers, including the Medical Device Manufacturers Association (MDMA), hammered the new draft guidance for its introduction of the concept of a critical task due to the expansive effect that would have on the need for human factors studies for medical devices.
Huma Therapeutics Ltd. received the first EU Class IIb approval for a software as a medical device (SaMD) product, winning the certification for its system for collecting and analysing patient data across multiple disease indications, the company reported. The approval will open up the market for digital health apps, with customers now able to link into Huma’s underlying technical platform to develop their own digital health apps and companion diagnostics, avoiding the need to then get their own, separate EU medical device certification.
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