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Attorneys said many questions remain about the regulation of laboratory developed tests after the FDA lost its legal fight. A recent warning letter could be a clue to future enforcement.

Attorneys said many questions remain about LDT regulation after the FDA lost its legal fight. A recent warning letter could be a clue to future enforcement.

Coating for the guidewires could come off and get left in patients, which could result in extended or additional procedures. No serious injuries or deaths have been tied to the recall.

The guidance should help health systems safely manage and monitor AI tools in a financially sustainable manner, which can be “a real challenge” for providers, said CHAI CEO Dr. Brian Anderson.

At a satellite kickoff event to the annual BIO meeting, investment bankers and VCs gave reasons for optimism amid a ‘volatile’ period for the industry.

  El mercado tecnológico avanza rápidamente y los precios de los móviles nuevos no paran de subir, cada vez más personas optan por alternativas más sostenibles y económicas. Una de las opciones que más crecimiento ha experimentado en los &uacu …

Regeneron did not bid higher on the genetic testing company because of “its assessment of 23andMe’s remaining value,” according to a spokesperson for the pharma.

Analysts at Jefferies give Roche and Prothena’s Phase III study just a 25% to 40% probability of success.

The data released by a group of Democrat lawmakers found 338 rural hospitals were at risk of closure, conversion or service cutbacks if the reconciliation bill becomes law.

At 12 weeks, weight loss ranged from 2.6% to 11.3%, compared to a gain of 0.2% in the placebo group. Guggenheim analysts were also impressed by the tolerability profile.