As it advances its nonopioid analgesic ATX-101 breakthrough therapy through a phase IIb registration trial, Allay Therapeutics secured $57.5 million in a series D round, which included an investment from the company’s Japanese partner. ATX-101, a configuration of sodium ion channel blocker bupivacaine and a biopolymer, which is in a phase IIb registration study, is designed to offer pain relief following total knee arthroplasty.
In the midst of June’s peak wedding season, Highridge Medical LLC called it splitsville – selling its bone healing division to Avista Healthcare Partners. The latest separation continues the sundering of what Zimmer Biomet Holdings Inc. so carefully joined together a decade ago.
The U.S. FDA’s Center for Devices and Radiological Health is recovering from a guidance drought that spanned several months in the first part of calendar year 2025, starting with a guidance on the Q-sub process.
Paradromics Inc. became the latest company developing a brain-computer interface (BCI) system to implant its technology, Connexus, into a human. The device was safely implanted, it recorded electrical brain signals and was removed intact in less than 20 minutes. Paradromics hopes to begin clinical trials later this year.
Far from eliminating the need for weight-loss procedures, glucagon-like peptide-1 receptor agonists could drive more people to seek them out. At least that’s what Fractyl Health Inc. and Bariendo Inc. hope, and they have strong evidence to support their case with a recent meta-analysis showing that individuals discontinuing the popular weight loss medications regain all their weight and more within two years.
U.S. Medicare coverage of telehealth and telemedicine sometimes seems to lag inappropriately, but fears of fraud were borne out in a conviction obtained recently by the Department of Justice.
The U.S. Federal Trade Commission said it sent letters to 37 contact lens prescribers reminding them a failure to automatically provide patients with a prescription can result in fines of more than $53,000 per violation.
Vantive Health LLC, formerly the kidney care business of Baxter International Inc., plans to invest $1 billion over the next five years in development of digitally enabled dialysis products, innovation in acute organ support therapy options and expanding production capacity.
The U.S. FDA’s decision to grant breakthrough device designation for Bivacor Inc.’s titanium total artificial heart (TAH) sent real hearts aflutter at the Huntington, Calif.-based company’s headquarters. While the designation supports use of the TAH as a bridge to transplant for adults with biventricular or univentricular heart failure for whom current options are insufficient or unsuitable, Bivacor hopes its device will eventually serve as a long-term heart replacement.
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