1. HealthSplash owner sentenced to 19 years for $1 billion Medicare brace fraud
A Kansas software CEO whose platform generated false doctors' orders has been sentenced in one of DOJ's largest telemedicine fraud cases.
Brett Blackman, owner of HealthSplash and its DMERx ordering platform, was sentenced on October 14 after a jury convicted him of health care fraud, kickback and false-statement conspiracies [1]. DOJ says suppliers and pharmacies billed more than $1 billion and were paid more than $450 million for braces and other items that physicians approved without meaningful contact with patients [1]. (See lead article.)
2. FDA flags Edwards mitral valve delivery system after balloon bursts; one death reported
Edwards Lifesciences has told hospitals to pull four lots of the delivery system used to implant its SAPIEN M3 transcatheter mitral valve.
Edwards has received three reports of balloons bursting during inflation on Commander M delivery systems, which can cause embolism or leave the device impossible to retrieve, potentially forcing surgery in patients considered unsuitable for it [2]. As of October 5, the company had reported one death and one serious injury; affected lots are 67718561, 67804014, 67887043 and 67887044, and units from other lots may still be used [2]. FDA posted the early alert on October 15 [2].
3. FDA expands Anktiva to papillary-only BCG-unresponsive bladder cancer, without a new randomized trial
The agency approved the first treatment specifically for this group by extending evidence from the drug's earlier approval in carcinoma in situ.
On October 14, FDA approved Anktiva (nogapendekin alfa inbakicept-pmln) plus BCG for adults with BCG-unresponsive, high-grade, papillary-only non-muscle invasive bladder cancer, citing the earlier 77-patient carcinoma in situ trial (62% complete response) and the scientific similarity of the two disease forms [3]. The decision follows a 2025 refusal-to-file letter and a public dispute between ImmunityBio and the agency, and came nearly three months before its January 2027 target date, Fierce Pharma reports [4].
4. Crick-trained researcher admits fabrication; Science Translational Medicine retracts COVID vaccine paper
A 2022 mouse study of a broader-acting SARS-CoV-2 vaccine, cited 83 times, has been pulled for fabricated data and falsified images.
Retraction Watch reports that first author Kevin Ng, a former Ph.D. student at the Francis Crick Institute, admitted responsibility during the journal's investigation, which the notice says casts doubt on other experiments in the paper [5]. It is his second retraction for fabrication this year, after a Nature paper on lung cancer immunotherapy; the Crick says it found no evidence of malpractice by other authors [5].
Digest references
U.S. Department of Justice, Office of Public Affairs. "Owner of Health Care Software Company Sentenced to 19 Years in Prison for $1B Medicare Fraud." Press release, October 15, 2026. Link
U.S. Food and Drug Administration, Center for Devices and Radiological Health. "Early Alert: Transcatheter Mitral Valve Delivery System Issue from Edwards Lifesciences." FDA, October 15, 2026. Link
U.S. Food and Drug Administration. "FDA Approves First Treatment for Certain People With BCG-Unresponsive Bladder Cancer." FDA, October 14, 2026. Link
Liu A. "FDA clears ImmunityBio's Anktiva expansion in bladder cancer after regulatory whiplash." Fierce Pharma, October 14, 2026 (updated October 15). Link
Orrall A. "Former Crick Ph.D. student loses COVID vaccine paper for fabrication." Retraction Watch, October 14, 2026. Retraction notice DOI: 10.1126/scitranslmed.aem5154. Link
