Illumina Inc. wasted no time in returning to the M&A front, closing the acquisition of Fluent Biosciences Inc. on July 9 with cash on hand, just a fortnight after freeing itself of Grail Inc. Fluent’s single-cell analysis technology expands Illumina’s presence in the life sciences, possibly marking a turn away from the diagnostics focus that led to the Grail debacle. The acquisition price was not disclosed. Read More
The draft version of the U.S. Medicare hospital outpatient rule for 2025 carries more than a dozen applications for a new technology pass-through payment next year, but Boston Scientific Corp.’s Agent balloon for treatment of in-stent restenosis might not be eligible for NTPT payment because of a debate over whether the device can be assigned to an existing Healthcare Common Procedure Coding System code. Read More
In the recently cast shadow of the U.S. Supreme Court’s Loper Bright decision that unraveled Chevron deference for federal agencies, the FTC’s broad rule banning noncompete employment clauses is on shaky ground. The first tremor hit July 3 when the U.S. District Court for the Northern District of Texas temporarily enjoined the FTC Noncompete Rule that is scheduled to go into effect Sept. 4 on the grounds that the agency overstepped its authority. Read More
Roche Holdings AG received CE mark for its artificial intelligence (AI)-enabled continuous glucose monitoring (CGM) system, Accu-Chek Smartguide. The company said the solution addresses the unmet need around diabetes management and glycemic control as it offers critical predictions to people living with type 1 and type 2 diabetes. Read More
Setpoint Medical Corp. reported positive topline results from its landmark RESET-RA study. The study evaluated the Setpoint system as a potential new neuroimmune modulation treatment for adults living with moderate-to-severe rheumatoid arthritis who are incomplete responders or are intolerant to biologic or targeted synthetic disease-modifying anti-rheumatic drugs. Read More
In an action two years in the making, Dublin-based Medtronic plc withdrew a series of endotracheal tubes because of complaints of lost functionality that carries the risk of respiratory and/or cardiac arrest. Read More
From no hope to viable treatments, BioWorld is there to cover the breakthroughs in medicine. Listen to Randy Osborne explain why the BioWorld team is ‘always on the lookout for what's next.’ Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: CRCbioscreen Crossject, Exthera, Mainz Biomed, Smartcella, Sensome SAS, Signature Orthopaedics, Surfix, Xylocor. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Remsleep. Read More
