Researchers from Arizona State University and Mayo Clinic have filed for protection of wireless, battery-free brain implants which may be used in the monitoring, stimulation, and treatment of epilepsy, tumors, neurodegenerative disorders, neuroinflammatory conditions and trauma.
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.
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.
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.
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.
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.
Soligenix Inc. investors were extremely enthusiastic about the positive interim update for the company’s cancer therapy and light device, Hybryte, for treating for treating early stage cutaneous T-cell lymphoma. The Princeton, N.J.-based company’s stock (NASDAQ:SNGX) soared a whopping 464% before closing at a more modest but still massive of 271% increase to $7.42 each on July 9.
Confidence in working with Chinese biopharma companies has dropped by 30% to 50% for U.S.-based life sciences companies, with Chinese contract development and manufacturing organizations the hardest hit, according to a recent LEK survey of global life sciences companies on the impact of the pending U.S. Biosecure Act.
Pulse Biosciences Inc. received U.S. FDA breakthrough device designation for its Cellfx cardiac surgery system with surgical clamp for ablation of atrial fibrillation. The Cellfx system uses nanosecond pulsed field ablation technology to deliver durable, continuous transmural ablation.
The U.S. Medicare draft prospective payment system for end-stage renal disease encodes a few changes that will cheer industry, including a provision that would increase patient access to pharmaceuticals that are available only in oral form.