The U.S. House of Representatives has passed an agreement with the Biden administration on the debt ceiling, a deal that does not affect mandatory spending programs such as Medicare. However, the agreement, which still must gain the Senate’s stamp of approval, appears to eliminate any chance of yet more monies for the National Institutes of Health or the FDA, two programs of intense interest for companies in the life sciences.
Brightheart raises €2M for software to detect congenital heart defects in fetuses
Startup Brightheart SAS raised €2 million (US$2.14 million) in seed financing, from Sofinnova Partners, that will allow the company to accelerate the development of its artificial intelligence (AI) software, which helps physicians detect congenital heart defects in fetuses. Brightheart hopes that the technology will improve the detection of complex congenital heart defects during prenatal ultrasound screening as intervening early could address fetal malformations or abnormalities and greatly improve a baby’s chance of survival.
Orlucent receives breakthrough device designation for hand-held mole imaging system
If Orlucent Inc. has its way atypical moles in adults will soon give up their secrets to clinicians on the lookout for skin cancer, this after the Los Gatos, Calif.-based company received a U.S. breakthrough device designation for its non-invasive Orlucent skin fluorescence imaging system. The system is a hand-held point-of-care molecular-based imaging device that identifies “tissue remodeling activity” inside atypical moles that could be a precursor to early melanoma.
Gasp! Wesper challenges polysomnography with wireless, portable sleep lab
Wesper, a longitudinal and wireless clinical-grade sleep testing platform, showed ‘exceptional accuracy’ in a head-to-head comparison with polysomnography in a study published in The Journal of Clinical Sleep Medicine. The wireless, longitudinal sleep testing platform had a 0.951 correlation with the cumbersome gold standard test for sleep apnea.
SCOTUS: Belief, not interpretation, at heart of FCA violations
With False Claims Act (FCA) whistleblower lawsuits multiplying, the U.S. Supreme Court provided some clarity as to what constitutes a false claim in a unanimous opinion handed down today. "What matters for an FCA case is whether the defendant knew the claim was false,” Justice Clarence Thomas wrote for the court in U.S. ex rel. Scutte v. Supervalu Inc. In other words, the court explained, liability in an FCA suit depends on whether defendants believed their claims were false – not on whether they had interpreted a law or regulation in an “objectively reasonable" way, even if the regulation may be ambiguous. While Supervalu involves claims pharmacies submitted to Medicare and Medicaid, the ramifications of the court’s opinion could impact biopharma and med-tech, as well.
Also in the news
Atomvie Global Radiopharma, Avacta, Bioai, Cardiorenal, Caris, Concertai, Ezra, Masimo, Nalu Medical, Philips, Quipt Home Medical, Remission Medical, Remware, Seegene, Side Health, Swift Medical, Telesis, Valve Medical, Volitionrx, Wesper