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GE HealthCare to acquire Intelerad for $2.3B

GE HealthCare

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GE HealthCare

The Chicago-based imaging systems manufacturer said it plans to pay the purchase price in cash, believing the acquisition demonstrates its “continued commitment to cloud-enabled and AI-powered solutions.” 

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Oral heart failure drug receives FDA’s fast track designation

A majority of medical devices involved in Class I recalls were never required by the U.S. Food and Drug Administration (FDA) to undergo premarket or postmarket clinical testing, according to new research published in Annals of Internal Medicine.[1]

A clinical trial focused on patients with HFpEF is expected to be completed by July 2026.

  • Read more about Oral heart failure drug receives FDA’s fast track designation

Did Boston Scientific pull the plug too early on TAVR devices? Cardiologists weigh in

Boston Scientific ACURATE neo2 aortic valve system self-expanding TAVR valve.

The Acurate neo2 aortic valve system. Image courtesy of Boston Scientific. 

Boston Scientific stopped selling its Acurate TAVR systems after they underperformed in a few key trials and failed to gain FDA approval. Was it the right call?

  • Read more about Did Boston Scientific pull the plug too early on TAVR devices? Cardiologists weigh in

FDA clears new ‘smart shirt’ for real-time cardiopulmonary monitoring

Hexoskin Medical System

The Hexoskin Medical System. Image courtesy of Hexoskin.

According to Hexoskin, the newly cleared technology offers significant value for hospitals and health systems as well as researchers conducting clinical trials. 

  • Read more about FDA clears new ‘smart shirt’ for real-time cardiopulmonary monitoring

Solis Mammography names new CMO, opens 3 additional imaging centers

Emily Sedgwick 2

The breast screening provider has picked Emily Sedgwick, MD, MBA, to fill the key role and is opening new centers in Texas and Colorado. 

  • Read more about Solis Mammography names new CMO, opens 3 additional imaging centers

Allstate sues imaging centers, physicians seeking $5M from alleged insurance scam

allstate

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Allstate

Filed in a Texas federal court, the complaint names Prime Imaging Partners and Memorial MRI & Diagnostic among numerous defendants, with the alleged auto-injury scheme occurring from 2019-2023. 

  • Read more about Allstate sues imaging centers, physicians seeking $5M from alleged insurance scam

Outpatient Imaging Affiliates inks 2 new hospital joint ventures

piedmont

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Piedmont

The private equity-backed, Tennessee-based imaging group is expanding in Georgia and Missouri through partnerships with Piedmont and BJC HealthCare, respectively. 

  • Read more about Outpatient Imaging Affiliates inks 2 new hospital joint ventures

ACLU sues FDA over unanswered Freedom of Information Act request

ACLU American Civil Libertries Union

A group of people march promoting the ACLU. Photo by carterdayne.

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iStock

The agency is accused of failing to respond to a records request related to its upcoming review of the legality of abortion pills and interstate prescribing practices. The ACLU is asking a federal judge to enforce FOIA law.

  • Read more about ACLU sues FDA over unanswered Freedom of Information Act request

Trump’s former FDA commissioner joins board of UnitedHealth

UnitedHealthcare UHC UnitedHealth

Scott Gottlieb, MD, will take on the new position “effective immediately.” UnitedHealth Group did not say what, if any, steering committee the former FDA lead will sit on. 

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Telix says new kidney cancer imaging agent alters treatment plans for 50% of patients

Telix Pharmaceuticals

The positive findings come after the U.S. Food and Drug Administration previously shared concerns related to sterility assurance issues during the drug’s production.

  • Read more about Telix says new kidney cancer imaging agent alters treatment plans for 50% of patients

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