FDA expands Embrace hydrogel embolic approval to peripheral arterial bleeding
A resorbable liquid embolic adds hemorrhage control to its label on a 130-patient pivotal trial.
Instylla said Oct. 29 that the FDA approved an expanded indication for its Embrace Hydrogel Embolic System covering embolization of peripheral arterial bleeds in vessels 6 mm or smaller, building on the August 2025 premarket approval for hypervascular tumors in peripheral arteries 5 mm or smaller [1][2]. In the single-arm HALT trial of 130 patients at 22 US sites, the device met both primary endpoints: 100% freedom from major adverse events and 90.0% clinical success (no rebleeding from the target lesion) through 30 days, per company data on file [1]. The polyethylene glycol hydrogel is non-adhesive and coagulation-independent, which the company pitches as an edge over coils in coagulopathic patients [1].
Federal judge strikes CMS’s narrowed “medically frail” exemption from Medicaid work rules
The Jan. 1, 2027 work-requirement deadline stands; one clause of the CMS rule does not.
U.S. District Judge Richard G. Stearns in Boston ruled Oct. 29 that CMS exceeded its authority when its June 2026 interim final rule limited the statutory “medically frail” exemption to people whose condition “significantly impairs” their ability to meet work requirements; he vacated that language and permanently enjoined it, with a six-month stay [3]. The case, Massachusetts v. Oz, was brought by 25 states and the District of Columbia; the court upheld the rule’s 12-month data lookback and self-attestation limits and said the Jan. 1, 2027 start date is unchanged [3][4]. CMS did not immediately comment [4].
Labor Department finalizes PBM fee-disclosure rule for self-insured employer plans
Rebates, spread pricing and clawbacks must be itemized for plan years beginning July 1, 2027.
The Department of Labor on Oct. 29 finalized a rule requiring pharmacy benefit managers to disclose direct and indirect compensation, including drugmaker rebates, spread pricing and copay clawbacks, to large self-insured group health plans before contracting and every six months thereafter, with annual audit rights [5][6]. DOL estimates savings of up to $22 billion over a decade; the trade group PCMA called the rule government overreach, and STAT reports legal challenges are expected [5][6][7].
FDA proposes first overhaul of infant formula nutrient standards in nearly 30 years
Iodine, manganese and vitamins A and D are up first; DHA and ARA are on the table.
The FDA on Oct. 29 issued the first of three planned proposed rules revising the 30 nutrient requirements for infant formula, updating standards for iodine, manganese, vitamin A and vitamin D, reaffirming four others, and seeking input on requiring commonly added ingredients such as DHA, ARA and L-carnitine [8]. The agency also released new chemical-contaminant testing data and a public dashboard; comments are due Feb. 26, 2027 [8].
Digest references
Instylla Inc., “Instylla’s Embrace Hydrogel Embolic System Receives FDA Approval for Peripheral Arterial Bleeds,” press release, Oct. 29, 2026. instylla.com
Endovascular Today, “Instylla’s Embrace HES Approved for Peripheral Arterial Bleeds,” Oct. 29, 2026. evtoday.com
U.S. District Court for the District of Massachusetts, Memorandum and Order, Commonwealth of Massachusetts et al. v. Oz et al., No. 1:26-cv-12962-RGS, Oct. 29, 2026 (posted by the Massachusetts Attorney General). mass.gov
Nate Raymond, Reuters, “US judge blocks Trump limits to Medicaid work requirement exceptions,” Oct. 29, 2026 (via SRN News). srnnews.com
Rebecca Pifer Parduhn, Healthcare Dive, “Labor Department finalizes sweeping PBM disclosure rule,” Oct. 29, 2026. healthcaredive.com
Elizabeth Casolo, Becker’s Payer Issues, “‘No more negotiating in the dark’: Labor Department finalizes PBM transparency rule,” Oct. 29, 2026. beckerspayer.com
Bob Herman, STAT, “New federal rule will require prescription drug middlemen to share secret payments data,” Oct. 29, 2026. statnews.com
U.S. Department of Health and Human Services / FDA, “Trump Administration Announces First Major Update to Infant Formula Standards in Nearly 30 Years,” Oct. 29, 2026. hhs.gov
