Following on a trifecta of regulatory wins, Optellum Ltd. raised $14 million in a series A funding round to commercialize its artificial intelligence (AI)-enabled lung cancer diagnostic platform. Optellum’s Virtual Nodule Clinic, which helps physicians identify and monitor patients at-risk of lung cancer, has received U.S. FDA clearance, CE-MDR in the European Union and UKCA in the U.K. Read More

The U.S. FDA’s final report for the software pre-certification (pre-cert) pilot program for software as a medical device (SaMD) highlighted a number of both positive and negative developments, but the agency reiterated its call for new statutory authorities for review of SaMD. However, the agency also acknowledged that the pilot was itself compromised by the absence of that statutory authority because the absence of such authority means that the results of these mock product reviews cannot be legally walled off from non-pilot applications. Read More

Life science startup Surge Inc. raised $2.6 million in a financing led by Hcvd and Boutique Venture Partners. The funds will be used to advance its artificial intelligence (AI)-powered technology aimed at making a patient’s surgical journey safer. Read More

The COVID-19 pandemic may or may not be over, depending on which member of the U.S. government’s executive branch one asks, but the FDA’s device center has drawn much tighter lines around its emergency use authorization (EUA) program for COVID-19 tests. Read More

Siview SAS chose the European Society of Cataract and Refractive Surgeons annual congress to announce its latest capital increase.  Read More

As part of its obligations under the 21^st Century Cures Act, the U.S. FDA is proposing two new rules to harmonize sections of its regulations on human subject protection and institutional review boards with the revised Common Rule, which provides for the protection of human subjects in federally funded research. Read More

New hires and promotions in the med-tech industry, including: Blue Wind Medical, Catheter Precision, Cue Health, Flagship Biosciences, Onward Medical, Woebot Health. Read More

Med-tech firms raising money in public or private financings, including: Cranius. Read More

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Caredx. Read More

Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Akon Lighting, B. Braun, Ceryx, Eversana, Gatc, Icon Capital, Nemaura Medical, Osypka, Pacbio, Prosoma, Siemens Healthineers, Starboard, Varian. Read More