The recently concluded American Diabetes Association’s (ADA) 83rd Scientific Sessions continued to build powerful use cases for continuous glucose monitors in an ever-wider population and to highlight the value of automated insulin delivery (AID) systems that are getting ever-closer to duplicating the function of a natural pancreas. In addition to the news from Medtronic plc and Dexcom Inc. BioWorld covered earlier this week, Abbott Laboratories, Tandem Diabetes Care Inc. and Insulet Corp. also presented bright projections for future performance. Read More
Gleamer SAS reported closing a series B round of $29.6 million to help expand its portfolio of artificial intelligence (AI) systems for radiologists and ramp international expansion. The exercise was led by Supernova Invest SAS who put up $11 million, joined by Heal Capital SAS with $5.5 million. Read More
The U.K. government created a new £21 million ($US26.55 million) fund to accelerate the roll out of artificial intelligence (AI) diagnostics and treatment tools across the NHS. The AI Diagnostic Fund will enable hospitals to bid for funding to speed up the deployment of the most promising AI imaging and decision support tools to help patients with cancers, strokes and heart conditions. Read More
Precision diagnostics company Inoviq Ltd.’s stock soared 44% on the news that its breast cancer diagnostic, SubB2M/CA15-3, detected all stages of breast cancer with 87% accuracy, 81% sensitivity and 93% specificity. The clinical validation study that included 483 samples outperformed the standard of care CAS15-3 test, demonstrating an area under the curve (AUC) of .93 compared to .70. Read More
The U.S. Office of Inspector General might not be the source of routine rules of the road for information blocking for electronic health records (EHRs), but the agency is tasked with some of the enforcement load. OIG just announced that $1 million fines for violations of information blocking rules will go into force in late August, a penalty that can accrue astonishingly quickly as it may apply per violation rather than per a series of related violations. Read More
Conformis Inc. has inked a definitive agreement to be acquired by Restor3d Inc., in a move that could potentially create a formidable presence in the personalized orthopedics space. Under the agreement, Restor3d will acquire all outstanding shares of Conformis common stock (NYSE:CFMS) at $2.27 per share in cash. The purchase price represents a roughly 96% premium to Conformis’ closing price on June 22, 2023. Read More
Makers of dental equipment don’t typically show up on the U.S. FDA enforcement radar screen, but the introduction of biologics and software into routine dental practice has upped the regulatory stakes. This can be seen in the June 20, 2023, warning to Vitang Technology LLC, of Tustin, Calif., which cited the company for failure to validate a change of software used in orthodontic treatment planning systems, but the FDA reinforced the notion that claiming that the agency approved or cleared the device is also a violation of the Code of Federal Regulations. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Ciliatech, Intrinsic Therapeutics, Neurometrix. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aurora Spine, Double Black, LG Electronics, Luciole Medical, Pamgene, Rair Health, Shineco, Spiegelberg, Yangzhou Kangling. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Kalos Medical. Read More
