Clinical updates, including trial initiations, enrollment status and data readouts and publications: Amplifi Vascular, Inspire Medical, Neurent Medical, Pulse Biosciences.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Surgical Theater.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Agilent, Berlin Heals, Infinx Healthcare, Natus Sensory, Seqwell, Scanogen, Smith+Nephew, SPT Labtech, Tikak, Voxology AI, Work Medical, Ypsomed.
Ottobock SE & Co. KGaA got the Frankfurt Stock Exchange on its feet and dancing with Germany’s largest IPO in more than 18 months Oct. 9. The €808 million (US$934.23 million) gave the prosthetics company a market capitalization of €4.2 billion (US$4.88 billion), which rapidly rose as the share price shot up from €66 to €72 at the start of trading. The second med-tech to go public in October should have more company soon, with U.S. molecular diagnostics company Billiontoone Inc. filing Oct. 7 for an IPO with placeholder value of $100 million.
ARC (Accelerate, Redesign, Collaborate), the innovation arm of Israel’s Sheba Medical Center is looking to use the principles of gaming and simulation to create smarter, more scalable solutions that will benefit both patients and providers.
The International Medical Device Regulators Forum (IMDRF) has issued a draft guidance for predetermined change control plans for software as a medical device. The problem for advocates of regulatory harmonization is that the IMDRF draft overlaps awkwardly with the FDA’s approach, which has issued separate policies for the AI subset of device software functions and a separate guidance for all other devices, including non-AI software.
New hires and promotions in the med-tech industry, including: Biomerica, Channel Medsystems, Fifty 1 AI Labs, Mission Bio, Modular Devices, Perceptive Imaging.
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